Ibuprofen Art 31 - CMDh agreement av... · Ibuprofen Actavis 200 mg . 200 mg : Coated tablet . Oral...

384
Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the Member States

Transcript of Ibuprofen Art 31 - CMDh agreement av... · Ibuprofen Actavis 200 mg . 200 mg : Coated tablet . Oral...

Page 1: Ibuprofen Art 31 - CMDh agreement av... · Ibuprofen Actavis 200 mg . 200 mg : Coated tablet . Oral use : 12 . Member State (in EEA) Marketing authorisation holder . INN . Invented

Annex I

List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the

Member States

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Austria Abbott GmbH Perfektastasse 84a 1230 Wien Austria

Ibuprofen Brufen 400 mg - Filmtabletten

400 mg Film-coated tablet Oral use

Austria Abbott GmbH Perfektastasse 84a 1230 Wien Austria

Ibuprofen Brufen 600 mg - Filmtabletten

600 mg Film-coated tablet Oral use

Austria Merz Consumer Care Austria GmbH Guglgasse 17 1110 Wien Austria

Ibuprofen Dismenol forte Ibuprofen 400 mg Filmtabletten

400 mg Film-coated tablet Oral use

Austria Merz Consumer Care Austria GmbH Guglgasse 17 1110 Wien Austria

Ibuprofen Dismenol Ibuprofen 200 mg Filmtabletten

200 mg Film-coated tablet Oral use

Austria Reckitt Benckiser Deutschland GmbH Theodor Heuss Anlage 68165 Mannheim Germany

Ibuprofen natrium Nurofen 400 mg überzogene Tabletten

400 mg Coated tablet Oral use

Austria Reckitt Benckiser Deutschland GmbH Theodor Heuss Anlage 68165 Mannheim Germany

Ibuprofen Nurofen Liquid 200 mg Kapseln

200 mg Capsule, soft Oral use

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Austria Sanova Pharma GmbH Haidestraße 4 1110 Wien Austria

Ibuprofen Dolgit 800 mg - Filmtabletten

800 mg Film-coated tablet Oral use

Austria Sanova Pharma GmbH Haidestraße 4 1110 Wien Austria

Ibuprofen Dolgit 200 mg - Dragees

200 mg Coated tablet Oral use

Austria Sanova Pharma GmbH Haidestraße 4 1110 Wien Austria

Ibuprofen Dolgit 600 mg - Dragees

600 mg Coated tablet Oral use

Austria Sanova Pharma GmbH Haidestraße 4 1110 Wien Austria

Ibuprofen Dolgit 400 mg - Dragees

400 mg Coated tablet Oral use

Austria Sanova Pharma GmbH Haidestraße 4 1110 Wien Austria

Ibuprofen Dolgit 400 mg - Kapseln

400 mg Capsule, soft Oral use

Austria Bayer Austria GmbH Herbststraße 6-10 1160 Wien Austria

Ibuprofen Aktren 400 mg - Kapseln

400 mg Capsule, soft Oral use

Austria Astellas Pharma GmbH Linzer Straße221 E02 1140 Wien Austria

Ibuprofen Dolofort 400 mg - Filmtabletten

400 mg Film-coated tablet Oral use

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Austria Reckitt Benckiser Deutschland GmbH Theodor Heuss Anlage 68165 Mannheim Germany

Ibuprofen Nurofen Meltlets Mint 200 mg Schmelztabletten

200 mg Orodispersible tablet Oral use

Austria Reckitt Benckiser Deutschland GmbH Theodor Heuss Anlage 68165 Mannheim Germany

Ibuprofen Nurofen Meltlets 200 mg Schmelztabletten

200 mg Orodispersible tablet Oral use

Austria Abbott GmbH Perfektastasse 84a 1230 Wien Austria

Ibuprofen Brufen 400 mg Brausegranulat

400 mg Effervescent granules Oral use

Austria Boehringer Ingelheim International GmbH Binger Straße 173 55216 Ingelheim am Rhein Germany

Ibuprofen BoxaGrippal 200 mg/30 mg - Filmtabletten

200 mg 30 mg

Film-coated tablet Oral use

Austria Sigmapharm Arzneimittel GmbH Leystraße 129 1200 Wien Austria

Ibuprofen ib-u-ron 75 mg Zäpfchen

75 mg Suppository Rectal use

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Austria Reckitt Benckiser Deutschland GmbH Theodor Heuss Anlage 68165 Mannheim Germany

Ibuprofen Nurofen rapid 200 mg Weichkapseln

200 mg Capsule, soft Oral use

Austria Sigmapharm Arzneimittel GmbH Leystraße 129 1200 Wien Austria

Ibuprofen ib-u-ron 150 mg Zäpfchen

150 mg Suppository Rectal use

Austria Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Ibunin 200 mg Filmtabletten

200 mg Film-coated tablet Oral use

Austria Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Ibunin 400 mg Filmtabletten

400 mg Film-coated tablet Oral use

Austria Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Ibuprofen Actavis 400 mg Filmtabletten

400 mg Film-coated tablet Oral use

Austria Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Ibuprofen Actavis 600 mg Filmtabletten

600 mg Film-coated tablet Oral use

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Austria Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Ibuprofen Actavis 200 mg Filmtabletten

200 mg Film-coated tablet Oral use

Austria Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Ibuprofen Actavis 800 mg Filmtabletten

800 mg Film-coated tablet Oral use

Austria Abbott GmbH Perfektastasse 84a 1230 Wien Austria

Ibuprofen Ibuprofen Rockspring 200 mg Brausegranulat

200 mg Effervescent granules Oral use

Austria Genericon Pharma GmbH Hafnerstraße 211 8054 Graz Austria

Ibuprofen Ibuprofen Genericon 400 mg Filmtabletten

400 mg Film-coated tablet Oral use

Austria Gebro Pharma GmbH Bahnhofbichl 13 6391 Fieberbrunn Austria

Ibuprofen Dexibuprofen Gebro 300 mg Pulver zur Herstellung einer Suspension zum Einnehmen

300 mg Powder for oral suspension

Oral use

Austria Gebro Pharma GmbH Bahnhofbichl 13 6391 Fieberbrunn Austria

Ibuprofen Dexibuprofen Gebro 400 mg Pulver zur Herstellung einer Suspension zum Einnehmen

400 mg Powder for oral suspension

Oral use

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Austria Takeda Austria GmbH St. Peter Straße 25 4020 Linz Austria

Ibuprofen Ibumetin 200 mg - Dragees

200 mg Coated tablet Oral use

Austria Takeda Austria GmbH St. Peter Straße 25 4020 Linz Austria

Ibuprofen Ibumetin forte 400 mg - Filmtabletten

400 mg Film-coated tablet Oral use

Austria ratiopharm Arzneimittel Vertriebs-GmbH Albert Schweitzer Gasse 3 1140 Wien Austria

Ibuprofen WICK DayMed Duo 200 mg/30 mg Filmtabletten

200 mg 30 mg

Film-coated tablet Oral use

Austria Reckitt Benckiser Deutschland GmbH Theodor Heuss Anlage 68165 Mannheim Germany

Ibuprofen Nurofen 200 mg - Dragees

200 mg Coated tablet Oral use

Austria Kwizda Pharma GmbH Effingergasse 21 1160 Wien Austria

Ibuprofen Adolorin Ibuforte 400 mg Dragees

400 mg Coated tablet Oral use

Austria ratiopharm Arzneimittel Vertriebs-GmbH Albert Schweitzer Gasse 3 1140 Wien Austria

Ibuprofen Ibuprofen ratiopharm 4 % Sirup für Kinder

40 mg/ml Syrup Oral use

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Austria Genericon Pharma GmbH Hafnerstraße 211 8054 Graz Austria

Ibuprofen Ibuprofen Genericon 600 mg Filmtabletten

600 mg Film-coated tablet Oral use

Austria Boehringer Ingelheim International GmbH Binger Straße 173 55216 Ingelheim am Rhein Germany

Ibuprofen Thomaprodol 400 mg - Weichkapseln

400 mg Capsule, soft Oral use

Austria G.L. Pharma GmbH Schloßplatz 1 8502 Lannach Austria

Ibuprofen Ibuprofen G.L. 400 mg - Filmtabletten

400 mg Film-coated tablet Oral use

Austria G.L. Pharma GmbH Schloßplatz 1 8502 Lannach Austria

Ibuprofen Ibuprofen G.L. 600 mg - Filmtabletten

600 mg Film-coated tablet Oral use

Austria Reckitt Benckiser Deutschland GmbH Theodor Heuss Anlage 68165 Mannheim Germany

Ibuprofen Nurofen rapid 400 mg Weichkapseln

400 mg Capsule, soft Oral use

Austria Gebro Pharma GmbH Bahnhofbichl 13 6391 Fieberbrunn Austria

Dexibuprofen Seractil forte 400 mg - Filmtabletten

400 mg Film-coated tablet Oral use

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Austria Gebro Pharma GmbH Bahnhofbichl 13 6391 Fieberbrunn Austria

Dexibuprofen Seractil 200 mg - Filmtabletten

200 mg Film-coated tablet Oral use

Austria Gebro Pharma GmbH Bahnhofbichl 13 6391 Fieberbrunn Austria

Dexibuprofen Seractil 300 mg - Filmtabletten

300 mg Film-coated tablet Oral use

Austria Gebro Pharma GmbH Bahnhofbichl 13 6391 Fieberbrunn Austria

Dexibuprofen Eu-Med 200 mg Schmerztabletten

200 mg Tablet Oral use

Austria Gebro Pharma GmbH Bahnhofbichl 13 6391 Fieberbrunn Austria

Dexibuprofen Monactil 200 mg - Filmtabletten

200 mg Film-coated tablet Oral use

Austria Gebro Pharma GmbH Bahnhofbichl 13 6391 Fieberbrunn Austria

Dexibuprofen Atriscal 200 mg - Filmtabletten

200 mg Film-coated tablet Oral use

Austria Gebro Pharma GmbH Bahnhofbichl 13 6391 Fieberbrunn Austria

Dexibuprofen Atriscal 300 mg - Filmtabletten

300 mg Film-coated tablet Oral use

Austria Gebro Pharma GmbH Bahnhofbichl 13 6391 Fieberbrunn Austria

Dexibuprofen Atriscal 400 mg - Filmtabletten

400 mg Film-coated tablet Oral use

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Austria Gebro Pharma GmbH Bahnhofbichl 13 6391 Fieberbrunn Austria

Dexibuprofen Dexibuprofen "Gebro" 200 mg - Filmtabletten

200 mg Film-coated tablet Oral use

Austria Gebro Pharma GmbH Bahnhofbichl 13 6391 Fieberbrunn Austria

Dexibuprofen Dexibuprofen "Gebro" 300 mg - Filmtabletten

300 mg Film-coated tablet Oral use

Austria Gebro Pharma GmbH Bahnhofbichl 13 6391 Fieberbrunn Austria

Dexibuprofen Dexibuprofen "Gebro" 400 mg - Filmtabletten

400 mg Film-coated tablet Oral use

Austria Gebro Pharma GmbH Bahnhofbichl 13 6391 Fieberbrunn Austria

Dexibuprofen Movone 200 mg - Filmtabletten

200 mg Film-coated tablet Oral use

Austria Gebro Pharma GmbH Bahnhofbichl 13 6391 Fieberbrunn Austria

Dexibuprofen Movone 300 mg - Filmtabletten

300 mg Film-coated tablet Oral use

Austria Gebro Pharma GmbH Bahnhofbichl 13 6391 Fieberbrunn Austria

Dexibuprofen Movone 400 mg - Filmtabletten

400 mg Film-coated tablet Oral use

Belgium Pfizer bv Rivium Westlaan 142 2909 LD, Capelle a/d Ijssel The Netherlands

Ibuprofen Advil 200 200 mg Effervescent tablet Oral use

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Belgium BGP Products Belgium Avenue Einstein 12 1300 Wavre Belgium

Ibuprofen Brufen 40 mg/ml Oral suspension Oral use

Belgium BGP Products Belgium Avenue Einstein 12 1300 Wavre Belgium

Ibuprofen Brufen 400 400 mg Coated tablet Oral use

Belgium BGP Products Belgium Avenue Einstein 12 1300 Wavre Belgium

Ibuprofen Brufen Forte 600 600 mg Film-coated tablet Oral use

Belgium BGP Products Belgium Avenue Einstein 12 1300 Wavre Belgium

Ibuprofen Brufen Granules 600 600 mg Granules for oral solution

Oral use

Belgium BGP Products Belgium Avenue Einstein 12 1300 Wavre Belgium

Ibuprofen Brufen Retard 800 800 mg Prolonged-release tablet

Oral use

Belgium BGP Products Belgium Avenue Einstein 12 1300 Wavre Belgium

Ibuprofen Brufen Granules 400 mg Effervescent granules Oral use

Belgium Teva Pharma Belgium N.V. Laarstraat 16 2610 Wilrijk Belgium

Ibuprofen Buprophar 200 mg Coated tablet Oral use

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Belgium Teva Pharma Belgium N.V. Laarstraat 16 2610 Wilrijk Belgium

Ibuprofen Buprophar 400 mg Coated tablet Oral use

Belgium Socobom nv Louizalaan 149 bus 24 1050 Brussel Belgium

Ibuprofen Dolofin 400 mg Coated tablet Oral use

Belgium Laboratoria Qualiphar N.V./S.A. Rijksweg 9 2880 Bornem Belgique

Ibuprofen Extrapan Ibruprofenum 200 mg

200 mg Coated tablet Oral use

Belgium Laboratoria Qualiphar N.V./S.A. Rijksweg 9 2880 Bornem Belgique

Ibuprofen Extrapan Ibruprofenum 400 mg

400 mg Coated tablet Oral use

Belgium Laboratoires Belges Pharmacobel SA Avenue de Scheut 48 1070 Bruxelles Belgique

Ibuprofen Ibumed 200 mg 200 mg Tablet Oral use

Belgium Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Ibuprofen Actavis 200 mg

200 mg Coated tablet Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Belgium Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Ibuprofen Actavis 400 mg

400 mg Coated tablet Oral use

Belgium Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Ibuprofen Actavis 600 mg

600 mg Coated tablet Oral use

Belgium Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Ibuprofen Actavis 800 mg

800 mg Coated tablet Oral use

Belgium Boehringer Ingelheim International GmbH Binger Straße 173 55216 Ingelheim am Rhein Germany

Ibuprofen Ibuprofen Boehringer Ingelheim 400 mg

400 mg Capsule Oral use

Belgium Eurogenerics Afgekort "E.G." Heizel Esplanade b22 1020 Laken Belgium

Ibuprofen Ibuprofen EG 200 mg 200 mg Coated tablet Oral use

Belgium Eurogenerics Afgekort "E.G." Heizel Esplanade b22 1020 Laken Belgium

Ibuprofen Ibuprofen EG 40 mg/ml 40 mg/ml Oral suspension Oral use

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Belgium Eurogenerics Afgekort "E.G." Heizel Esplanade b22 1020 Laken Belgium

Ibuprofen Ibuprofen EG 400 mg 400 mg Coated tablet Oral use

Belgium Eurogenerics Afgekort "E.G." Heizel Esplanade b22 1020 Laken Belgium

Ibuprofen sodium hydrate

Ibuprofen EG 400 mg 512 mg Effervescent tablet Oral use

Belgium Eurogenerics Afgekort "E.G." Heizel Esplanade b22 1020 Laken Belgium

Ibuprofen Ibuprofen EG 600 mg 600 mg Coated tablet Oral use

Belgium Eurogenerics Afgekort "E.G." Heizel Esplanade b22 1020 Laken Belgium

Ibuprofen Ibuprofen EG 800 mg 800 mg Tablet Oral use

Belgium Mylan bvba/sprl Terhulpsesteenweg 6a 1560 Hoeilaart Belgium

Ibuprofen lysine Ibuprofen Lysine Mylan 200 mg

342 mg Coated tablet Oral use

Belgium Mylan bvba/sprl Terhulpsesteenweg 6a 1560 Hoeilaart Belgium

Ibuprofen lysine Ibuprofen Lysine Mylan 400 mg

684 mg Coated tablet Oral use

Belgium Mylan bvba/sprl Terhulpsesteenweg 6a 1560 Hoeilaart Belgium

Ibuprofen lysine Ibuprofen Lysine Mylan Pharma 200 mg

342 mg Coated tablet Oral use

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Belgium Mylan bvba/sprl Terhulpsesteenweg 6a 1560 Hoeilaart Belgium

Ibuprofen lysine Ibuprofen Lysine Mylan Pharma 400 mg

684 mg Coated tablet Oral use

Belgium Boehringer Ingelheim International GmbH Binger Straße 173 55216 Ingelheim am Rhein Germany

Ibuprofen pseudoephedrine hydrochloride

Ibuprofen Pseudoéphedrine HCL Boehringer Ingelheim 200 mg -30 mg

200 mg 30 mg

Coated tablet Oral use

Belgium Sandoz nv/sa Telecom Gardens Medialaan 40 1800 Vilvoorde Belgium

Ibuprofen Ibuprofen Sandoz 200 mg

200 mg Coated tablet Oral use

Belgium Sandoz nv/sa Telecom Gardens Medialaan 40 1800 Vilvoorde Belgium

Ibuprofen Ibuprofen Sandoz 40 mg/ml

40 mg/ml Oral suspension Oral use

Belgium Sandoz nv/sa Telecom Gardens Medialaan 40 1800 Vilvoorde Belgium

Ibuprofen Ibuprofen Sandoz 400 mg

400 mg Coated tablet Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Belgium Sandoz nv/sa Telecom Gardens Medialaan 40 1800 Vilvoorde Belgium

Ibuprofen Ibuprofen Sandoz 600 mg

600 mg Coated tablet Oral use

Belgium Sandoz nv/sa Telecom Gardens Medialaan 40 1800 Vilvoorde Belgium

Ibuprofen Ibuprofen Sandoz 800 mg

800 mg Coated tablet Oral use

Belgium Teva Pharma Belgium N.V. Laarstraat 16 2610 Wilrijk Belgium

Ibuprofen Ibuprofen Teva 200 mg 200 mg Coated tablet Oral use

Belgium Teva Pharma Belgium N.V. Laarstraat 16 2610 Wilrijk Belgium

Ibuprofen Ibuprofen Teva 400 mg 400 mg Coated tablet Oral use

Belgium Teva Pharma Belgium N.V. Laarstraat 16 2610 Wilrijk Belgium

Ibuprofen Ibuprofen Teva 600mg 600 mg Tablet Oral use

Belgium Rockspring Healthcare Limited 38/40 Chamberlayne Road London NW10 3JE United Kingdom

Ibuprofen codeine phosphate hemihydrate

Ibuprofen/Codeine Phosphate Hemihydrate Rockspring 400mg/30mg

400 mg 30 mg

Coated tablet Oral use

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Belgium Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Ifenin 200mg 200 mg Film-coated tablet Oral use

Belgium Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Ifenin 400mg 400 mg Film-coated tablet Oral use

Belgium BGP Products Belgium Avenue Einstein 12 1300 Wavre Belgium

Ibuprofen Malafene 100mg/5ml 20 mg/ml Syrup Oral use

Belgium Reckitt Benckiser (Healthcare) -SA/NV Researchdreef 20 1070 Brussels Belgium

Ibuprofen Nurofen 200 200 mg Coated tablet Oral use

Belgium Reckitt Benckiser (Healthcare) -SA/NV Researchdreef 20 1070 Brussels Belgium

Ibuprofen Nurofen 200 fastcaps 200 mg Capsule, soft Oral use

Belgium Reckitt Benckiser (Healthcare) -SA/NV Researchdreef 20 1070 Brussels Belgium

Ibuprofen Nurofen 200 fastsodium 200 mg Coated tablet Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Belgium Reckitt Benckiser (Healthcare) -SA/NV Researchdreef 20 1070 Brussels Belgium

Ibuprofen Nurofen 400 400 mg Coated tablet Oral use

Belgium Reckitt Benckiser (Healthcare) -SA/NV Researchdreef 20 1070 Brussels Belgium

Ibuprofen Nurofen 400 fastcaps 400 mg Capsule, soft Oral use

Belgium Reckitt Benckiser (Healthcare) -SA/NV Researchdreef 20 1070 Brussels Belgium

Ibuprofen Nurofen 400 fastpowder 400 mg Powder for oral solution

Oral use

Belgium Reckitt Benckiser (Healthcare) -SA/NV Researchdreef 20 1070 Brussels Belgium

Ibuprofen Nurofen 400 fastsodium 400 mg Coated tablet Oral use

Belgium Reckitt Benckiser (Healthcare) -SA/NV Researchdreef 20 1070 Brussels Belgium

Ibuprofen lysine Nurofen 400 fasttabs 684 mg Film-coated tablet Oral use

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Belgium Reckitt Benckiser (Healthcare) -SA/NV Researchdreef 20 1070 Brussels Belgium

Ibuprofen Nurofen fastsodium voor kinderen vanaf 12 jaar 200mg

200 mg Coated tablet Oral use

Belgium Reckitt Benckiser (Healthcare) -SA/NV Researchdreef 20 1070 Brussels Belgium

Ibuprofen lysine Nurofen Lysine 200 mg 342 mg Film-coated tablet Oral use

Belgium Reckitt Benckiser (Healthcare) -SA/NV Researchdreef 20 1070 Brussels Belgium

Ibuprofen lysine Nurofen Lysine 400 mg 684 mg Film-coated tablet Oral use

Belgium Reckitt Benckiser (Healthcare) -SA/NV Researchdreef 20 1070 Brussels Belgium

Ibuprofen Nurofen Smelttabletten 200 mg

200 mg Orodispersible tablet Oral use

Belgium Reckitt Benckiser (Healthcare) -SA/NV Researchdreef 20 1070 Brussels Belgium

Ibuprofen Nurofen voor kinderen vanaf 12 jaar 200 mg

200 mg Coated tablet Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Belgium Omega Pharma Belgium NV Industriepark "De Prijkels" Venecoweg 26 9810 Nazareth Belgium

Ibuprofen Optalidon 200 Nieuw formule

200 mg Coated tablet Oral use

Belgium Omega Pharma Belgium NV Industriepark "De Prijkels" Venecoweg 26 9810 Nazareth Belgium

Ibuprofen Optalidon 400 Nieuw formule

400 mg Coated tablet Oral use

Belgium Johnson & Johnson Consumer SA/NV Antwerpseweg 15-17 2340 Beerse Belgium

Ibuprofen lysine Perdofemina 400mg 684 mg Film-coated tablet Oral use

Belgium Johnson & Johnson Consumer SA/NV Antwerpseweg 15-17 2340 Beerse Belgium

Ibuprofen lysine Perrdophen 400mg 684 mg Coated tablet Oral use

Belgium Johnson & Johnson Consumer SA/NV Antwerpseweg 15-17 2340 Beerse Belgium

Ibuprofen lysine Perdotensio 200mg 342 mg Film-coated tablet Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Belgium Zambon SA/NV E.Demunterlaan 1/9 1090 Brussels Belgium

Ibuprofen Spidifen 200 mg 200 mg Granules for oral solution

Oral use

Belgium Zambon SA/NV E.Demunterlaan 1/9 1090 Brussels Belgium

Ibuprofen Spidifen 200 mg 200 mg Tablet Oral use

Belgium Zambon SA/NV E.Demunterlaan 1/9 1090 Brussels Belgium

Ibuprofen Spidifen 200 mg 200 mg Effervescent tablet Oral use

Belgium Zambon SA/NV E.Demunterlaan 1/9 1090 Brussels Belgium

Ibuprofen Spidifen 400 mg 400 mg Film-coated tablet Oral use

Belgium Zambon SA/NV E.Demunterlaan 1/9 1090 Brussels Belgium

Ibuprofen Spidifen 400 mg 400 mg Granules for oral solution

Oral use

Bulgaria Alvogen IPCo S.àr.l. Rue Heienhaff, 5 L-1736, Senningerberg Luxemburg

Ibuprofen Alvofen Express 200 mg Capsule, soft Oral use

Bulgaria Alvogen IPCo S.àr.l. Rue Heienhaff, 5 L-1736, Senningerberg Luxemburg

Ibuprofen Alvofen Express 400 mg Capsule, soft Oral use

21

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Bulgaria Ecopharm Group AD Cherni Vah blvd., bl. 3 1421 Sofia Bulgaria

Ibuprofen Doloren 200 mg Film-coated tablet Oral use

Bulgaria Ecopharm Group AD Cherni Vah blvd., bl. 3 1421 Sofia Bulgaria

Ibuprofen Doloren 400 mg Film-coated tablet Oral use

Bulgaria Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Ibuprofen Extralgin 200 mg Film-coated tablet Oral use

Bulgaria Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Ibuprofen Extralgin 400 mg Film-coated tablet Oral use

Bulgaria Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Ibuprofen Extralgin Gold 200 mg 30 mg

Film-coated tablet Oral use

Bulgaria STADA Arzneimittel AG Stadastr. 2-18 61118 Bad Vilbel Germany

Ibuprofen Flexistad 400 mg Film-coated tablet Oral use

22

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Bulgaria STADA Arzneimittel AG Stadastr. 2-18 61118 Bad Vilbel Germany

Ibuprofen Flexistad 600 mg Film-coated tablet Oral use

Bulgaria STADA Arzneimittel AG Stadastr. 2-18 61118 Bad Vilbel Germany

Ibuprofen Flexistad 800 mg Film-coated tablet Oral use

Bulgaria Tchaikapharma Highquality Medicines 1 G. M. Dimitrov Blvd Sofia, 1172 Bulgaria

Ibuprofen Ibufen 200 mg Effervescent tablet Oral use

Bulgaria Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Ibudolor 200 mg Film-coated tablet Oral use

Bulgaria Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Ibudolor 400 mg Film-coated tablet Oral use

Bulgaria Actavis EAD Atanas Dukov str. 29 1407 Sofia Bulgaria

Ibuprofen Ibudolor 300 mg Prolonged-release capsule, hard

Oral use

23

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Bulgaria US Pharmacia Sp. z o.o. Ziebicka st. 40 50-507 Wroclaw Poalnd

Ibuprofen Ibuprom 200 mg Coated tablet Oral use

Bulgaria US Pharmacia Sp. z o.o. Ziebicka st. 40 50-507 Wroclaw Poalnd

Ibuprofen Ibuprom Sprint MAX 400 mg Capsule, soft Oral use

Bulgaria US Pharmacia Sp. z o.o. Ziebicka st. 40 50-507 Wroclaw Poalnd

Ibuprofen Ibuprom Sprint Caps 200 mg Capsule, soft Oral use

Bulgaria US Pharmacia Sp. z o.o. Ziebicka st. 40 50-507 Wroclaw Poalnd

Ibuprofen Ibuprom Max 400 mg Coated tablet Oral use

Bulgaria US Pharmacia Sp. z o.o. Ziebicka st. 40 50-507 Wroclaw Poalnd

Ibuprofen pseudoephedrine hydrochloride

Ibuprom Sinus 200 mg 30 mg

Coated tablet Oral use

Bulgaria Abbott Products EOOD 48 Sitnyakovo blvd, Serdika offices 1505 Sofia Bulgaria

Ibuprofen Brufen 200 mg Effervescent tablet Oral use

24

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Bulgaria Abbott Products EOOD 48 Sitnyakovo blvd, Serdika offices 1505 Sofia Bulgaria

Ibuprofen codeine phosphate hemihydrate

Brufen Codeine 400 mg 30 mg

Film-coated tablet Oral use

Bulgaria Abbott Scandinavia AB P.O Box 1498 SE-171 29 Solna Sweden

Ibuprofen Brufen 20 mg/ml Oral suspension Oral use

Bulgaria Abbott Scandinavia AB P.O Box 1498 SE-171 29 Solna Sweden

Ibuprofen Brufen Forte 40 mg/ml Oral suspension Oral use

Bulgaria Abbott Scandinavia AB P.O Box 1498 SE-171 29 Solna Sweden

Ibuprofen Brufen 400 mg Effervescent granules Oral use

Bulgaria Abbott Scandinavia AB P.O Box 1498 SE-171 29 Solna Sweden

Ibuprofen Brufen retard 800 mg Prolonged-release tablet

Oral use

Bulgaria Pabianickie Zakłady Farmaceutyczne Polfa S.A. Marszalka Pilsudskiego st. 5 95-200 Pabianice Poland

Ibuprofen Ibuprofen Polfa 200 mg Coated tablet Oral use

25

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Bulgaria Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany

Ibuprofen MIG-400 400 mg Film-coated tablet Oral use

Bulgaria Pharmaceutical plants Milve Ltd. 33 Nikola Mirchev 1113 Sofia Bulgaria

Ibuprofen Milorofen 200 mg Film-coated tablet Oral use

Bulgaria Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Ibuprofen Nurofen Express Forte 400 mg Capsule, soft Oral use

Bulgaria Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Ibuprofen Nurofen Forte 400 mg Coated tablet Oral use

Bulgaria Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Ibuprofen Nurofen Active 200 mg Orodispersible tablet Oral use

26

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Bulgaria Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Ibuprofen Nurofen 200 mg Coated tablet Oral use

Bulgaria Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Ibuprofen sodium dihydrate

Nurofen Femina Forte 512 mg Coated tablet Oral use

Bulgaria Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Ibuprofen pseudoephedrine

Nurofen STOPCOLD 200 mg 30 mg

Film-coated tablet Oral use

Bulgaria Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Ibuprofen sodium dihydrate

Nurofen X2 256 mg Coated tablet Oral use

27

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Bulgaria Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Ibuprofen lysine Nurofen Migraine Pain 342 mg Film-coated tablet Oral use

Bulgaria Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Ibuprofen Nurofen Express 200 mg Capsule, soft Oral use

Bulgaria Boehringer Ingelheim International GmbH Binger Straße 173 55216 Ingelheim am Rhein Germany

Ibuprofen pseudoephedrine

Mucogrip 200 mg 30 mg

Film-coated tablet Oral use

Bulgaria Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Ibuprofen Ibalgin Fast 400 mg Film-coated tablet Oral use

Croatia Berlin-Chemie Menarini Hrvatska d.o.o. Horvatova 80a, Zagreb 10000 Croatia

Ibuprofen Berlistar forte 40 mg/ml oralna suspenzija

40 mg/ml Oral suspension Oral use

28

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Croatia Alkaloid d.o.o., Ulica grada Vukovara 226f Zagreb 10000 Croatia

Ibuprofen BlokMax Lady 200 mg filmom obložene tablete

200 mg Film-coated tablet Oral use

Croatia Abbott Laboratories d.o.o. Koranska 2 Zagreb 10000 Croatia

Ibuprofen Brufen 400 mg filmom obložene tablete

400 mg Film-coated tablet Oral use

Croatia Abbott Laboratories d.o.o. Koranska 2 Zagreb 10000 Croatia

Ibuprofen Brufen 400 mg šumeće granule

400 mg Effervescent granules Oral use

Croatia Abbott Laboratories d.o.o. Koranska 2 Zagreb 10000 Croatia

Ibuprofen Brufen 600 mg filmom obložene tablete

600 mg Film-coated tablet Oral use

Croatia Abbott Laboratories d.o.o. Koranska 2 Zagreb 10000 Croatia

Ibuprofen Brufen 600 mg šumeće granule

600 mg Effervescent granules Oral use

Croatia Abbott Laboratories d.o.o. Koranska 2 Zagreb 10000 Croatia

Ibuprofen Brufen Effect 200 mg šumeće granule

200 mg Effervescent granules Oral use

Croatia Abbott Laboratories d.o.o. Koranska 2 Zagreb 10000 Croatia

Ibuprofen Brufen Effect 400 mg šumeće granule

400 mg Effervescent granules Oral use

29

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Croatia Abbott Laboratories d.o.o. Koranska 2 Zagreb 10000 Croatia

Ibuprofen Brufen forte 40 mg/ml oralna suspenzija

40 mg/ml Oral suspension Oral use

Croatia Abbott Laboratories d.o.o. Koranska 2 Zagreb 10000 Croatia

Ibuprofen Brufen SR 800 mg tablete s produljenim oslobađanjem

800 mg Film-coated prolonged-release tablet

Oral use

Croatia Abbott Laboratories d.o.o. Koranska 2 Zagreb 10000 Croatia

Ibuprofen Dalsy forte 40 mg/ml oralna suspenzija

40 mg/ml Oral suspension Oral use

Croatia Abbott Laboratories d.o.o. Koranska 2 Zagreb 10000 Croatia

Ibuprofen Dalsy sirup 20 mg/ml Syrup Oral use

Croatia Fidifarm d.o.o. Obrtnička 37, Rakitje Brestovje 10437 Croatia

Ibuprofen Fidiprofen 200 mg šumeće tablete

200 mg Effervescent tablet Oral use

Croatia Fidifarm d.o.o. Obrtnička 37, Rakitje Brestovje 10437 Croatia

Ibuprofen pseudoephedrine

Fidiprofen flu 200 mg + 30 mg tablete

200 mg 30 mg

Tablet Oral use

30

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Croatia sanofi-aventis Croatia d.o.o., Heinzelova 70 Zagreb 10000 Croatia

Ibuprofen Ibalgin 400 mg filmom obložene tablete

400 mg Film-coated tablet Oral use

Croatia sanofi-aventis Croatia d.o.o., Heinzelova 70 Zagreb 10000 Croatia

Ibuprofen Ibalgin Rapid 400 mg filmom obložene tablete

400 mg Film-coated tablet Oral use

Croatia PharmaS d.o.o., Radnička cesta 47 Zagreb 10000 Croatia

Ibuprofen IbuPhar 600 mg filmom obložene tablete

600 mg Film-coated tablet Oral use

Croatia PharmaS d.o.o., Radnička cesta 47 Zagreb 10000 Croatia

Ibuprofen Ibuprofen PharmaS 200 mg filmom obložene tablete

200 mg Film-coated tablet Oral use

Croatia PharmaS d.o.o., Radnička cesta 47 Zagreb 10000 Croatia

Ibuprofen Ibuprofen PharmaS 400 mg filmom obložene tablete

400 mg Film-coated tablet Oral use

Croatia Belupo, lijekovi i kozmetika d.d. Ulica Danica 5 Koprivnica 48000 Croatia

Ibuprofen Ibuprofen 100 mg/5 ml oralna suspenzija

20 mg/ml Oral suspension Oral use

31

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Croatia Belupo, lijekovi i kozmetika d.d. Ulica Danica 5 Koprivnica 48000 Croatia

Ibuprofen Ibuprofen 400 mg filmom obložene tablete

400 mg Film-coated tablet Oral use

Croatia Belupo, lijekovi i kozmetika d.d. Ulica Danica 5 Koprivnica 48000 Croatia

Ibuprofen Ibuprofen 600 mg filmom obložene tablete

600 mg Film-coated tablet Oral use

Croatia Belupo, lijekovi i kozmetika d.d. Ulica Danica 5 Koprivnica 48000 Croatia

Ibuprofen Ibuprofen Belupo 800 mg filmom obložene tablete

800 mg Film-coated tablet Oral use

Croatia Belupo, lijekovi i kozmetika d.d. Ulica Danica 5 Koprivnica 48000 Croatia

Ibuprofen Neofen 100 mg/5 ml sirup

20 mg/ml Syrup Oral use

Croatia Belupo, lijekovi i kozmetika d.d. Ulica Danica 5 Koprivnica 48000 Croatia

Ibuprofen Neofen 200 mg filmom obložene tablete

200 mg Film-coated tablet Oral use

32

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Croatia Belupo, lijekovi i kozmetika d.d. Ulica Danica 5 Koprivnica 48000 Croatia

Ibuprofen Neofen Direkt 200 mg raspadljive tablete za usta

200 mg Orodispersible tablet Oral use

Croatia Belupo, lijekovi i kozmetika d.d. Ulica Danica 5 Koprivnica 48000 Croatia

Ibuprofen Neofen Forte 400 mg filmom obložene tablete

400 mg Film-coated tablet Oral use

Croatia Farmal d.d. Branitelja domovinskog rata 8, Ludbreg 42230 Croatia

Ibuprofen Ibuprofen Farmal 200 mg filmom obložene tablete

200 mg Film-coated tablet Oral use

Croatia Farmal d.d. Branitelja domovinskog rata 8, Ludbreg 42230 Croatia

Ibuprofen Ibuprofen Farmal 400 mg filmom obložene tablete

400 mg Film-coated tablet Oral use

Croatia Farmal d.d. Branitelja domovinskog rata 8, Ludbreg 42230 Croatia

Ibuprofen Ibuprofen Farmal 600 mg filmom obložene tablete

600 mg Film-coated tablet Oral use

Croatia Farmal d.d. Branitelja domovinskog rata 8, Ludbreg 42230 Croatia

Ibuprofen Ibuprofen Farmal 800 mg tablete s produljenim oslobađanjem

800 mg Prolonged-release tablet

Oral use

33

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Croatia Berlin-Chemie Menarini Hrvatska d.o.o. Horvatova 80a Zagreb 10000 Croatia

Ibuprofen Ibustar 400 mg filmom obložene tablete

400 mg Film-coated tablet Oral use

Croatia Reckitt Benckiser d.o.o. Ulica grada Vukovara 269 D Zagreb 10000 Croatia

Ibuprofen Nurofen 200 mg obložene tablete

200 mg Coated tablet Oral use

Croatia Reckitt Benckiser d.o.o. Ulica grada Vukovara 269 D Zagreb 10000 Croatia

Ibuprofen Nurofen Forte 400 mg obložene tablete

400 mg Coated tablet Oral use

Croatia Reckitt Benckiser d.o.o. Ulica grada Vukovara 269 D Zagreb 10000 Croatia

Ibuprofen pseudoephedrine

Nurofen Cold and Flu 200 mg + 30 mg filmom obložene tablete

200 mg 40 mg

Film-coated tablet Oral use

Croatia Reckitt Benckiser d.o.o. Ulica grada Vukovara 269 D Zagreb 10000 Croatia

Ibuprofen Nurofen Rapid 200 mg meke kapsule

200 mg Capsule, soft Oral use

Croatia Reckitt Benckiser d.o.o. Ulica grada Vukovara 269 D Zagreb 10000 Croatia

Ibuprofen Nurofen Rapid Forte 400 mg meke kapsule

400 mg Capsule, soft Oral use

34

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Croatia PharmaSwiss d.o.o. Miramarska 23 Zagreb 10000 Croatia

Ibuprofen Rapidol S 200 mg kapsula, meka

200 mg Capsule, soft Oral use

Croatia PharmaSwiss d.o.o. Miramarska 23 Zagreb 10000 Croatia

Ibuprofen Rapidol S 400 mg kapsula, meka

400 mg Capsule, soft Oral use

Croatia Jadran Galenski Laboratorij d.d. Svilno 20 Rijeka 10000 Croatia

Ibuprofen pseudoephedrine

Rhinorelief 200 mg + 30 mg tablete

200 mg 30 mg

Tablet Oral use

Cyprus Varnavas Hadjipanayis Ltd Yiannou Kranidioti Avenue 226 2234 Latsia Strovolos Cyprus

Ibuprofen Brufen 400 mg Film-coated tablet Oral use

Cyprus Remedica IP Ltd Aharnon Street , Limassol Industrial Estate Limassol 3502 Cyprus

Ibuprofen Bulfan 200 mg Film-coated tablet Oral use

35

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Cyprus Remedica IP Ltd Aharnon Street , Limassol Industrial Estate Limassol 3502 Cyprus

Ibuprofen Bulfan 400 mg Film-coated tablet Oral use

Cyprus Reckitt Benckiser Hellas Chemical ABEE Taki Kavalieratou 7 Street 14564 Kato Kifissia Athens Greece

Ibuprofen Nurofen liquid capsule 200 mg Capsule, soft Oral use

Cyprus Reckitt Benckiser Hellas Chemical ABEE Taki Kavalieratou 7 Street 14564 Kato Kifissia Athens Greece

Ibuprofen Nurofen cold & flu 200 mg Film-coated tablet Oral use

Cyprus Reckitt Benckiser Hellas Chemical ABEE Taki Kavalieratou 7 Street 14564 Kato Kifissia Athens Greece

Ibuprofen Nurofen Express 400 mg Capsule, soft Oral use

Cyprus Lifepharma (Z.A.M) Ltd Agiou Nicolaou Street 8 1523 Lefkosia Cyprus

Ibuprofen sodium dihydrate

Nurofen Express 256 mg Tablet Oral use

36

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Cyprus Lifepharma (Z.A.M) Ltd Agiou Nicolaou Street 8 1523 Lefkosia Cyprus

Ibuprofen sodium dihydrate

Nurofen Express 512 mg Tablet Oral use

Cyprus Reckitt Benckiser Hellas Chemical ABEE Taki Kavalieratou 7 Street 14564 Kato Kifissia Athens Greece

Ibuprofen Nurofen 200 mg Film-coated tablet Oral use

Cyprus Remedica Ltd Aharnon str Limassol Industrial Estate Limassol 3508 Cyprus

Ibuprofen Perofen 200 mg Coated tablet Oral use

Cyprus Remedica Ltd Aharnon str Limassol Industrial Estate Limassol 3508 Cyprus

Ibuprofen Perofen 400 mg Coated tablet Oral use

Cyprus Remedica Ltd Aharnon str Limassol Industrial Estate Limassol 3508 Cyprus

Ibuprofen Perofen 200 mg Film-coated tablet Oral use

37

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Cyprus Remedica Ltd Aharnon str Limassol Industrial Estate Limassol 3508 Cyprus

Ibuprofen Perofen 400 mg Film-coated tablet Oral use

Cyprus Remedica Ltd Aharnon str Limassol Industrial Estate Limassol 3508 Cyprus

Ibuprofen Perofen 600 mg Film-coated tablet Oral use

Cyprus Medochemie Ltd 1-10 Constantinoupoleos str Limassol 3505 Cyprus

Ibuprofen Rufan 200 mg Film-coated tablet Oral use

Cyprus Medochemie Ltd 1-10 Constantinoupoleos str Limassol 3505 Cyprus

Ibuprofen Rupan Femme 400 mg Film-coated tablet Oral use

Cyprus Medochemie Ltd 1-10 Constantinoupoleos str Limassol 3505 Cyprus

Ibuprofen Rupan Max 200 mg Film-coated tablet Oral use

Cyprus Boehringer Ingelheim International GmbH Binger Straße 173 55216 Ingelheim am Rhein Germany

Ibuprofen Mucocold 200 mg Film-coated tablet Oral use

38

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Czech Republic

Pfizer Corporation Austria GmbH Floridsdorfer Hauptstraße 1 1210 Wien Austria

Ibuprofen Advil Rapid 400 mg Capsule, soft Oral use

Czech Republic

Apotex Europe B.V. Darwinweg 20 2333 CR Leiden The Netherlands

Ibuprofen Apo-ibuprofen 400 mg 400 mg Film-coated tablet Oral use

Czech Republic

Banner Pharmacaps Europe B.V. De Posthoornstraat 7 5048 AS Tilburg The Netherlands

Ibuprofen Apo-ibuprofen Rapid 400 mg soft capsules

400 mg Capsule, soft Oral use

Czech Republic

Abbott Laboratories, s.r.o. Evropská 2591/33d 160 00 Praha 6 - Hadovka Office Park Czech Republic

Ibuprofen Brufen 400 400 mg Film-coated tablet Oral use

Czech Republic

Abbott Laboratories, s.r.o. Evropská 2591/33d 160 00 Praha 6 - Hadovka Office Park Czech Republic

Ibuprofen Brufedol 400 mg šumivé granule

400 mg Effervescent granules Oral use

39

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Czech Republic

Abbott Laboratories, s.r.o. Evropská 2591/33d 160 00 Praha 6 - Hadovka Office Park Czech Republic

Ibuprofen Brufen 600 mg 600 mg Effervescent granules Oral use

Czech Republic

Abbott Laboratories, s.r.o. Evropská 2591/33d 160 00 Praha 6 - Hadovka Office Park Czech Republic

Ibuprofen Brufen Retard 800 mg 800 mg Prolonged-release tablet

Oral use

Czech Republic

Abbott Laboratories, s.r.o. Evropská 2591/33d 160 00 Praha 6 - Hadovka Office Park Czech Republic

Ibuprofen Brufen Sirup 20 mg/ml Syrup Oral use

Czech Republic

Dolorgiet GmbH & Co. KG Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany

Ibuprofen Dolgit 800 800 mg Film-coated tablet Oral use

Czech Republic

Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Ibuprofen Ibalgin 200 200 mg Film-coated tablet Oral use

40

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Czech Republic

Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Ibuprofen Ibalgin 400 400 mg Film-coated tablet Oral use

Czech Republic

Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Ibuprofen Ibalgin 600 600 mg Film-coated tablet Oral use

Czech Republic

Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Ibuprofen phenylephrine hydrochloride

Ibalgin Grip 200 mg/5 mg

200 mg 5 mg

Film-coated tablet Oral use

Czech Republic

Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Ibuprofen lysine Ibalgin Rapid 683,25 mg Film-coated tablet Oral use

Czech Republic

Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibuprofen Ibumax 200 mg 200 mg Film-coated tablet Oral use

Czech Republic

Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibuprofen Ibumax 400 mg 400 mg Film-coated tablet Oral use

41

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Czech Republic

Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibuprofen Ibumax 600 mg 600 mg Film-coated tablet Oral use

Czech Republic

Generics UK Albany Gate Darkes Lane Potters Bar Hertfordshire EN6 1AG United Kingdom

Ibuprofen lysine Ibumyl Rapid 400 mg 684 mg Film-coated tablet Oral use

Czech Republic

MEDREG s.r.o. Krčmářovská 223/33 196 00 Praha 9 Czech Republic

Ibuprofen Ibunex 200 mg potahované tablety

200 mg Film-coated tablet Oral use

Czech Republic

MEDREG s.r.o. Krčmářovská 223/33 196 00 Praha 9 Czech Republic

Ibuprofen Ibunex 400 mg potahované tablety

400 mg Film-coated tablet Oral use

Czech Republic

GALMED a.s. Těšínská 1349/296 716 00 Ostrava - Radvanice Czech Republic

Ibuprofen Ibuprofen 400 mg Galmed

400 mg Film-coated tablet Oral use

Czech Republic

ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 89150 Laichingen Germany

Ibuprofen Ibuprofen AL 400 400 mg Film-coated tablet Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Czech Republic

Dr. Max Pharma Ltd. First Floor Roxburge House, Regent Street 273-287 W1B 2HA London United Kingdom

Ibuprofen Ibuprofen Dr. MAX 200 MG potahované tablety

200 mg Film-coated tablet Oral use

Czech Republic

Dr. Max Pharma Ltd. First Floor Roxburge House, Regent Street 273-287 W1B 2HA London United Kingdom

Ibuprofen Ibuprofen Dr. MAX 400 mg potahované tablety

400 mg Film-coated tablet Oral use

Czech Republic

Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

Ibuprofen Ibuprofen Galpharm 200 mg potahované tablety

200 mg Film-coated tablet Oral use

Czech Republic

Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

Ibuprofen Ibuprofen Galpharm 400 mg potahované tablety

400 mg Film-coated tablet Oral use

43

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Czech Republic

Wrafton Laboratories Limited Exeter Road Wrafton Braunton Devon EX33 2DL United Kingdom

Ibuprofen lysine Ibuprofen Perrigo 200 mg potahované tablety

342 mg Film-coated tablet Oral use

Czech Republic

Wrafton Laboratories Limited Exeter Road Wrafton Braunton Devon EX33 2DL United Kingdom

Ibuprofen lysine Ibuprofen Perrigo 400 mg

684 mg Film-coated tablet Oral use

Czech Republic

Abbott Laboratories, s.r.o. Evropská 2591/33d 160 00 Praha 6 - Hadovka Office Park Czech Republic

Ibuprofen Brufedol 200 mg šumivé granule

200 mg Effervescent granules Oral use

Czech Republic

Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Ibuprofen pseudoephedrine hydrochloride

Modafen 200 mg 30 mg

Film-coated tablet Oral use

44

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Czech Republic

Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Ibuprofen Nurofen 200 mg 200 mg Coated tablet Oral use

Czech Republic

Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Ibuprofen Nurofen 400 mg 400 mg Coated tablet Oral use

Czech Republic

Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Ibuprofen lysine Nurofen Instant 400 mg rozpustný prášek

683,34 mg Powder for oral solution

Oral use

Czech Republic

Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Ibuprofen sodium dihydrate

Nurofen Neo 200 mg obalené tablety

256 mg Coated tablet Oral use

45

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Czech Republic

Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Ibuprofen sodium dihydrate

Nurofen Neo Femina 400 mg obalené tablety

512 mg Coated tablet Oral use

Czech Republic

Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Ibuprofen Nurofen Rapid 200 mg capsules

200 mg Capsule, soft Oral use

Czech Republic

Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Ibuprofen Nurofen Rapid 400 mg capsules

400 mg Capsule, soft Oral use

Czech Republic

Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Ibuprofen pseudoephedrine hydrochloride

Nurofen Stopgrip 200 mg 30 mg

Film-coated tablet Oral use

46

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Denmark Abbott Scandinavia AB Hemvärnsgatan 9 (Box 1498, 171 29 Solna) SE-171 54 Solna Sweden

Ibuprofen Brufen 400 mg Film-coated tablet Oral use

Denmark Takeda Pharma A/S Dybendal Alle 10 DK-2630 Taastrup Denmark

Ibuprofen Ibumetin 200 mg Film-coated tablet Oral use

Denmark Takeda Pharma A/S Dybendal Alle 10 DK-2630 Taastrup Denmark

Ibuprofen Ibumetin 400 mg Film-coated tablet Oral use

Denmark Takeda Pharma A/S Dybendal Alle 10 DK-2630 Taastrup Denmark

Ibuprofen Ibumetin 600 mg Film-coated tablet Oral use

Denmark Actavis Nordic A/S Ørnegårdsvej 16 DK-2820 Gentofte Denmark

Ibuprofen Ibuprofen "Actavis" 400 mg Film-coated tablet Oral use

Denmark Abbott Scandinavia AB Hemvärnsgatan 9 (Box 1498, 171 29 Solna) SE-171 54 Solna Sweden

Ibuprofen Brufen 600 mg Film-coated tablet Oral use

47

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Denmark Abbott Scandinavia AB Hemvärnsgatan 9 (Box 1498, 171 29 Solna) SE-171 54 Solna Sweden

Ibuprofen Brufen Retard 800 mg Prolonged-release tablet

Oral use

Denmark Infirst Healthcare Ltd. Strand 265 London WC2R 1BH United Kingdom

Ibuprofen Flarin 200 mg Capsule, soft Oral use

Denmark Infirst Healthcare Ltd. Strand 265 London WC2R 1BH United Kingdom

Ibuprofen Flarin 400 mg Capsule, soft Oral use

Denmark Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibuprofen Ibumax 400 mg Film-coated tablet Oral use

Denmark Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibuprofen Ibumax 600 mg Film-coated tablet Oral use

Denmark Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibuprofen Ibumax 200 mg Film-coated tablet Oral use

48

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Denmark Takeda Pharma A/S Dybendal Alle 10 DK-2630 Taastrup Denmark

Ibuprofen Ibumetin Retard 600 mg Prolonged-release tablet

Oral use

Denmark Alchemia Ltd., Jermyn Street 86 5th floor SW1 Y6AW London United Kingdom

Ibuprofen Ibunin 200 mg Film-coated tablet Oral use

Denmark Alchemia Ltd., Jermyn Street 86 5th floor SW1 Y6AW London United Kingdom

Ibuprofen Ibunin 400 mg Film-coated tablet Oral use

Denmark Alternova A/S Lodshusvej 11 DK-4230 Skælskør Denmark

Ibuprofen Ibupama 200 mg Film-coated tablet Oral use

Denmark Alternova A/S Lodshusvej 11 DK-4230 Skælskør Denmark

Ibuprofen Ibupama 400 mg Film-coated tablet Oral use

Denmark Alternova A/S Lodshusvej 11 DK-4230 Skælskør Denmark

Ibuprofen Ibupama 600 mg Film-coated tablet Oral use

49

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Denmark Actavis Nordic A/S Ørnegårdsvej 16 DK-2820 Gentofte Denmark

Ibuprofen Ibuprofen "Actavis" 600 mg Film-coated tablet Oral use

Denmark Alternova A/S Lodshusvej 11 DK-4230 Skælskør Denmark

Ibuprofen Ibuprofen "Alternova" 400 mg Film-coated tablet Oral use

Denmark Alternova A/S Lodshusvej 11 DK-4230 Skælskør Denmark

Ibuprofen Ibuprofen "Alternova" 600 mg Film-coated tablet Oral use

Denmark Alternova A/S Lodshusvej 11 DK-4230 Skælskør Denmark

Ibuprofen Ibuprofen "Alternova" 200 mg Film-coated tablet Oral use

Denmark Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofen Ibuprofen "Farmalider" 20 mg/ml Oral suspension Oral use

Denmark Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofen Ibuprofen "Farmalider" 40 mg/ml Oral suspension Oral use

50

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Denmark Orifarm Generics A/S Energivej 15 POB 69 DK-5260 Odense S Denmark

Ibuprofen Ibuprofen "Orifarm" 200 mg Film-coated tablet Oral use

Denmark Orifarm Generics A/S Energivej 15 POB 69 DK-5260 Odense S Denmark

Ibuprofen Ibuprofen "Orifarm" 400 mg Film-coated tablet Oral use

Denmark Orifarm Generics A/S Energivej 15 POB 69 DK-5260 Odense S Denmark

Ibuprofen Ibuprofen "Orifarm" 600 mg Film-coated tablet Oral use

Denmark Teva Denmark A/S Parallelvej 10-12, DK-2800 Kongens Lyndby Denmark

Ibuprofen Ibuprofen "Teva" 200 mg Film-coated tablet Oral use

Denmark Teva Denmark A/S Parallelvej 10-12 DK-2800 Kongens Lyndby Denmark

Ibuprofen Ibuprofen "Teva" 400 mg Film-coated tablet Oral use

Denmark Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany

Ibuprofen Ibustar 400 mg Film-coated tablet Oral use

51

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Denmark Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Ifenin 200 mg Film-coated tablet Oral use

Denmark Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Ifenin 400 mg Film-coated tablet Oral use

Denmark Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Ifenin 600 mg Film-coated tablet Oral use

Denmark Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Ifenin 800 mg Film-coated tablet Oral use

Denmark Takeda Pharma A/S Dybendal Alle 10 DK-2630 Taastrup Denmark

Ibuprofen Ipren 200 mg Film-coated tablet Oral use

Denmark Nordic Drugs AB Geijersgatan 2A Box 30035 200 61 Limhamn Sweden

Dexibuprofen Seractiv 300 mg Film-coated tablet Oral use

52

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Denmark Nordic Drugs AB Geijersgatan 2A Box 30035 200 61 Limhamn Sweden

Dexibuprofen Seractiv 400 mg Film-coated tablet Oral use

Estonia AS Grindeks Krustpils 53 LV-1057 Riga Latvia

Ibuprofen IBUFLUX 400 MG 400 mg Film-coated tablet Oral use

Estonia Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibuprofen IBUMAX 400 mg Film-coated tablet Oral use

Estonia Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

Ibuprofen NUROFEN 200 mg Coated tablet Oral use

Estonia STADA Arzneimittel AG Stadastr. 2-18 61118 Bad Vilbel Germany

Ibuprofen IBUDOLOR 200 mg Film-coated tablet Oral use

Estonia Lannacher Heilmittel GmbH Schlossplatz 1 A-8502 Lannach Austria

Ibuprofen IBUPROFEN LANNACHER

400 mg Film-coated tablet Oral use

53

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Estonia Lannacher Heilmittel GmbH Schlossplatz 1 A-8502 Lannach Austria

Ibuprofen IBUPROFEN LANNACHER

600 mg Film-coated tablet Oral use

Estonia AS Grindeks Krustpils 53 LV-1057 Riga Latvia

Ibuprofen IBUPROFEN-GRINDEKS 200 mg Film-coated tablet Oral use

Estonia Takeda Pharma AS Jaama 55B Polva 63308 Estonia

Ibuprofen IBUMETIN 200 mg Film-coated tablet Oral use

Estonia Takeda Pharma AS Jaama 55B Polva 63308 Estonia

Ibuprofen IBUMETIN 400 mg Film-coated tablet Oral use

Estonia Takeda Pharma AS Jaama 55B Polva 63308 Estonia

Ibuprofen IBUMETIN 600 mg Film-coated tablet Oral use

Estonia Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibuprofen IBUMAX 600 mg Film-coated tablet Oral use

54

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Estonia Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

Ibuprofen NUROFEN FORTE 400 mg Coated tablet Oral use

Estonia Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibuprofen IBUMAX 200 mg Film-coated tablet Oral use

Estonia Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

Ibuprofen NUROFEN EXPRESS 200 mg Coated tablet Oral use

Estonia Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

Ibuprofen NUROFEN FORTE EXPRESS

400 mg Coated tablet Oral use

Estonia Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany

Ibuprofen IBUSTAR 400 mg Film-coated tablet Oral use

55

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Estonia Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen IBUPROFEN ACTAVIS 200 mg Film-coated tablet Oral use

Estonia Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen IBUPROFEN ACTAVIS 400 mg Film-coated tablet Oral use

Estonia Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen IBUPROFEN ACTAVIS 600 mg Film-coated tablet Oral use

Estonia Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen IBUPROFEN ACTAVIS 800 mg Film-coated tablet Oral use

Estonia Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen IFENIN 200 mg Film-coated tablet Oral use

Estonia Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen IFENIN 400 mg Film-coated tablet Oral use

Estonia ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen IBUPROFEN-RATIOPHARM 400 MG

400 mg Film-coated tablet Oral use

56

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Estonia BGP Products SIA Mūkusalas 101 Riga, LV 1004 Latvia

Ibuprofen BRUFEN 200 mg Film-coated tablet Oral use

Estonia BGP Products SIA Mūkusalas 101 Riga, LV 1004 Latvia

Ibuprofen BRUFEN 400 mg Film-coated tablet Oral use

Estonia ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen BUTIFEN 400 MG 400 mg Film-coated tablet Oral use

Estonia BGP Products SIA Mūkusalas 101 Riga, LV 1004 Latvia

Ibuprofen BRUFEN 20 mg/ml Oral suspension Oral use

Estonia BGP Products SIA Mūkusalas 101 Riga, LV 1004 Latvia

Ibuprofen BRUFEN 800 mg Prolonged-release tablet

Oral use

Estonia BGP Products SIA Mūkusalas 101 Riga, LV 1004 Latvia

Ibuprofen BRUFEN 200 mg Effervescent granules Oral use

Estonia BGP Products SIA Mūkusalas 101 Riga, LV 1004 Latvia

Ibuprofen BRUFEN 400 mg Effervescent granules Oral use

57

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Estonia BGP Products SIA Mūkusalas 101 Riga, LV 1004 Latvia

Ibuprofen BRUFEN 600 mg Effervescent granules Oral use

Estonia BGP Products SIA Mūkusalas 101 Riga, LV 1004 Latvia

Ibuprofen codeine

BRUFEN PLUS 400 mg 30 mg

Film-coated tablet Oral use

Estonia BGP Products SIA Mūkusalas 101 Riga, LV 1004 Latvia

Ibuprofen BRUFEN 40 mg/ml Oral suspension Oral use

Finland Orion Pharma Orionintie 1 PL 65 02101 ESPOO Finland

Ibuprofen BURANA 200 mg Film-coated tablet Oral use

Finland Orion Pharma Orionintie 1 PL 65 02101 ESPOO Finland

Ibuprofen BURANA 400 mg Film-coated tablet Oral use

Finland Orion Pharma Orionintie 1 PL 65 02101 ESPOO Finland

Ibuprofen BURANA 600 mg Film-coated tablet Oral use

58

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Finland Orion Pharma Orionintie 1 PL 65 02101 ESPOO Finland

Ibuprofen BURANA 800 mg Film-coated tablet Oral use

Finland Orion Pharma Orionintie 1 PL 65 02101 ESPOO Finland

Ibuprofen BURANA 20 mg/ml Oral suspension Oral use

Finland Orion Pharma Orionintie 1 PL 65 02101 ESPOO Finland

Ibuprofen BURANA 40 mg/ml Oral suspension Oral use

Finland Orion Pharma Orionintie 1 PL 65 02101 ESPOO Finland

Ibuprofen BURANA SLOW 800 mg Prolonged-release tablet

Oral use

Finland Orion Pharma Orionintie 1 PL 65 02101 ESPOO Finland

Ibuprofen BURANA-CAPS 400 mg Capsule, soft Oral use

59

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Finland Orion Pharma Orionintie 1 PL 65 02101 ESPOO Finland

Ibuprofen BURANA-PORE 200 mg Effervescent tablet Oral use

Finland Orion Pharma Orionintie 1 PL 65 02101 ESPOO Finland

Ibuprofen BURANA-PORE 400 mg Effervescent tablet Oral use

Finland Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibuprofen IBUMAX 200 mg Film-coated tablet Oral use

Finland Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibuprofen IBUMAX 400 mg Film-coated tablet Oral use

Finland Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibuprofen IBUMAX 600 mg Film-coated tablet Oral use

Finland Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibuprofen IBUMAX 800 mg Film-coated tablet Oral use

60

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Finland Oy Leiras Takeda Paciuksenkatu 21 PL 1406 00101 HELSINKI Finland

Ibuprofen IBUMETIN 400 mg Film-coated tablet Oral use

Finland Oy Leiras Takeda Paciuksenkatu 21 PL 1406 00101 HELSINKI Finland

Ibuprofen IBUMETIN 600 mg Film-coated tablet Oral use

Finland Laboratorios Farmalider S.A. Aragoneses, 15. Polígono Industrial de Alcobendas 28108 ALCOBENDAS Spain

Ibuprofen IBUPROFEN FARMALIDER

20 mg/ml Oral suspension Oral use

Finland Laboratorios Farmalider S.A. Aragoneses, 15. Polígono Industrial de Alcobendas 28108 ALCOBENDAS Spain

Ibuprofen IBUPROFEN FARMALIDER

40 mg/ml Oral suspension Oral use

Finland Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

Ibuprofen IBUPROFEN GALPHARM 200 mg Film-coated tablet Oral use

61

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Finland Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

Ibuprofen IBUPROFEN GALPHARM 400 mg Film-coated tablet Oral use

Finland Orion Pharma Orionintie 1 PL 65 02101 ESPOO Finland

Ibuprofen IBUSAL 200 mg Film-coated tablet Oral use

Finland Orion Pharma Orionintie 1 PL 65 02101 ESPOO Finland

Ibuprofen IBUSAL 400 mg Film-coated tablet Oral use

Finland Orion Pharma Orionintie 1 PL 65 02101 ESPOO Finland

Ibuprofen IBUSAL 600 mg Film-coated tablet Oral use

Finland Orion Pharma Orionintie 1 PL 65 02101 ESPOO Finland

Ibuprofen IBUSAL 800 mg Film-coated tablet Oral use

62

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Finland Orion Pharma Orionintie 1 PL 65 02101 ESPOO Finland

Ibuprofen IBUTABS 400 mg Film-coated tablet Oral use

Finland ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen IBUXIN 200 mg Film-coated tablet Oral use

Finland ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen IBUXIN 400 mg Film-coated tablet Oral use

Finland ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen IBUXIN 600 mg Film-coated tablet Oral use

Finland ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen IBUXIN 800 mg Film-coated tablet Oral use

Finland ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen IBUXIN RAPID 400 mg Film-coated tablet Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Finland Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany

Ibuprofen MIG-400 400 mg Film-coated tablet Oral use

Finland Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Ibuprofen NUROFEN APPELSIINI 40 mg/ml Oral suspension Oral use

Finland Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Ibuprofen NUROFEN MANSIKKA 40 mg/ml Oral suspension Oral use

Finland Orion Pharma Orionintie 1 PL 65 02101 ESPOO Finland

Ibuprofen ascorbic acid

BURANA-C 400 mg 300 mg

Film-coated tablet Oral use

Finland Abbott Scandinavia AB P.O Box 1498 SE-171 29 Solna Sweden

Ibuprofen codeine

ARDINEX 200 mg 30 mg

Film-coated tablet Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

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Finland Orion Pharma Orionintie 1 PL 65 02101 ESPOO Finland

Ibuprofen codeine

BURANA COMP 200 mg 30 mg

Film-coated tablet Oral use

Finland Orion Pharma Orionintie 1 PL 65 02101 ESPOO Finland

Ibuprofen codeine

BURANA COMP 400 mg 60 mg

Film-coated tablet Oral use

Finland Abbott Oy Pihatörmä 1 B 02240 ESPOO Finland

Ibuprofen codeine

ARDINEX 400 mg 30 mg

Film-coated tablet Oral use

France PFIZER SANTE FAMILIALE 23-25, avenue du Docteur Lannelongue 75014 Paris France

Ibuprofen ADVIL 200 mg, comprimé enrobé

200 mg Coated tablet Oral use

France PFIZER SANTE FAMILIALE 23-25, avenue du Docteur Lannelongue 75014 Paris France

Ibuprofen ADVIL 400 mg, comprimé effervescent

400 mg Effervescent tablet Oral use

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INN Invented name Strength Pharmaceutical form

Route of administration

France PFIZER SANTE FAMILIALE 23-25, avenue du Docteur Lannelongue 75014 Paris France

Ibuprofen ADVIL 400 mg, comprimé enrobé

400 mg Coated tablet Oral use

France PFIZER SANTE FAMILIALE 23-25, avenue du Docteur Lannelongue 75014 Paris France

Ibuprofen ADVILCAPS 200 mg, capsule molle

200 mg Capsule, soft Oral use

France PFIZER SANTE FAMILIALE 23-25, avenue du Docteur Lannelongue 75014 Paris France

Ibuprofen ADVILCAPS 400 mg, capsule molle

400 mg Capsule, soft Oral use

France PFIZER SANTE FAMILIALE 23-25, avenue du Docteur Lannelongue 75014 Paris France

Ibuprofen ADVILEFF 200 mg, comprimé effervescent

200 mg Effervescent tablet Oral use

France PFIZER SANTE FAMILIALE 23-25, avenue du Docteur Lannelongue 75014 Paris France

Ibuprofen ADVILMED 400 mg, comprimé enrobé

400 mg Coated tablet Oral use

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INN Invented name Strength Pharmaceutical form

Route of administration

France PFIZER SANTE FAMILIALE 23-25, avenue du Docteur Lannelongue 75014 Paris France

Ibuprofen ADVILTAB 200 mg, comprimé enrobé

200 mg Coated tablet Oral use

France JOLLY JATEL 28, avenue Carnot 78951 Saint Germain en Laye Cedex France

Ibuprofen ALGIFENE 200 mg, comprimé enrobé

200 mg Tablet Oral use

France ELERTE 181 - 183, rue André Karman BP 101 93303 Aubervilliers Cedex France

Ibuprofen ANTARENE 200 mg, comprimé pelliculé

200 mg Tablet Oral use

France ELERTE 181 - 183, rue André Karman BP 101 93303 Aubervilliers Cedex France

Ibuprofen ANTARENE 400 mg, comprimé pelliculé

400 mg Tablet Oral use

France ELERTE 181 - 183, rue André Karman BP 101 93303 Aubervilliers Cedex France

Ibuprofen codeine

ANTARENE CODEINE 200 mg/30 mg, comprimé pelliculé

200 mg 30 mg

Tablet Oral use

67

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

France ELERTE 181 - 183, rue André Karman BP 101 93303 Aubervilliers Cedex France

Ibuprofen codeine

ANTARENE CODEINE 400 mg/60 mg, comprimé pelliculé

400 mg 60 mg

Tablet Oral use

France Abbott France 3 place Gustave Eiffel Bâtiment Florence 94518 Rungis Cedex France

Ibuprofen BRUFEN 400 mg, comprimé pelliculé

400 mg Tablet Oral use

France CRISTERS 22 quai Gallieni 92150 Suresnes France

Ibuprofen CRIFENE 400 mg, comprimé pelliculé

400 mg Tablet Oral use

France MERCK MEDICATION FAMILIALE 37, rue Saint-Romain 69379 Lyon Cedex 08 France

Ibuprofen ERGIX 200 mg DOULEUR ET FIEVRE, comprimé pelliculé

200 mg Tablet Oral use

France AJC INVEST Rue de la Rochefoucauld 6 16000 Angoulême France

Ibuprofen EXPANFEN 200 mg, comprimé enrobé

200 mg Tablet Oral use

France COOPER Place Lucien-Auvert 77020 Melun Cedex France

Ibuprofen GELUFENE 200 mg, gélule

200 mg Capsule, hard Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

France ELERTE 181 - 183, rue André Karman BP 101 93303 Aubervilliers Cedex France

Ibuprofen HEMAGENE TAILLEUR 200 mg, comprimé pelliculé

200 mg Tablet Oral use

France Banner Pharmacaps Europe B.V. De Posthoornstraat 7 5048 AS Tilburg The Netherlands

Ibuprofen IBUCAPS 200 mg, capsule molle

200 mg Capsule, soft Oral use

France Pharmachemie B.V. Swensweg 5 - Haarlem PO Box 552 2003 RN Haarlem The Netherlands

Ibuprofen IBUFEN 200 mg, comprimé enrobé

200 mg Tablet Oral use

France Pharmachemie B.V. Swensweg 5 - Haarlem PO Box 552 2003 RN Haarlem The Netherlands

Ibuprofen IBUFEN 400 mg, comprimé enrobé

400 mg Tablet Oral use

France Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen IBUPROFENE ACTAVIS 400 mg, comprimé pelliculé

400 mg Film-coated tablet Oral use

69

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INN Invented name Strength Pharmaceutical form

Route of administration

France Biogaran Boulevard Charles de Gaulle 15 92700 Colombes France

Ibuprofen IBUPROFENE ALMUS 200 mg, comprimé pelliculé

200 mg Film-coated tablet Oral use

France Biogaran Boulevard Charles de Gaulle 15 92700 Colombes France

Ibuprofen IBUPROFENE ALMUS 400 mg, comprimé pelliculé

400 mg Film-coated tablet Oral use

France ARROW GENERIQUES 26, avenue Tony Garnier 69007 Lyon France

Ibuprofen IBUPROFENE ARROW 200 mg, comprimé enrobé

200 mg Coated tablet Oral use

France ARROW GENERIQUES 26, avenue Tony Garnier 69007 Lyon France

Ibuprofen IBUPROFENE ARROW 400 mg, comprimé pelliculé

400 mg Film-coated tablet Oral use

France ARROW GENERIQUES 26, avenue Tony Garnier 69007 Lyon France

Ibuprofen IBUPROFENE ARROW CONSEIL 400 mg, comprimé pelliculé

400 mg Film-coated tablet Oral use

France INTERNATIONAL DRUG DEVELOPMENT 5, rue Simonet 75013 Paris France

Ibuprofen IBUPROFENE BIO VALYS 400 mg, comprimé effervescent

400 mg Effervescent tablet Oral use

70

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

France Biogaran Boulevard Charles de Gaulle 15 92700 Colombes France

Ibuprofen IBUPROFENE BIOGARAN 200 mg, comprimé pelliculé

200 mg Film-coated tablet Oral use

France Biogaran Boulevard Charles de Gaulle 15 92700 Colombes France

Ibuprofen IBUPROFENE BIOGARAN 400 mg, comprimé pelliculé

400 mg Film-coated tablet Oral use

France Biogaran Boulevard Charles de Gaulle 15 92700 Colombes France

Ibuprofen IBUPROFENE BIOGARAN CONSEIL 200 mg, comprimé pelliculé

200 mg Film-coated tablet Oral use

France Biogaran Boulevard Charles de Gaulle 15 92700 Colombes France

Ibuprofen IBUPROFENE BIOGARAN CONSEIL 400 mg, comprimé pelliculé

400 mg Film-coated tablet Oral use

France CRISTERS 22 quai Gallieni 92150 Suresnes France

Ibuprofen IBUPROFENE CRISTERS 200 mg, comprimé enrobé

200 mg Coated tablet Oral use

France CRISTERS 22 quai Gallieni 92150 Suresnes France

Ibuprofen IBUPROFENE CRISTERS 200 mg, comprimé pelliculé

200 mg Film-coated tablet Oral use

71

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

France CRISTERS 22 quai Gallieni 92150 Suresnes France

Ibuprofen IBUPROFENE CRISTERS 400 mg, comprimé pelliculé

400 mg Film-coated tablet Oral use

France EG LABO - LABORATOIRES EUROGENERICS "Le Quintet" - bâtiment A 12, rue Danjou 92517 Boulogne Billancourt Cedex France

Ibuprofen IBUPROFENE EG 200 mg, comprimé pelliculé

200 mg Film-coated tablet Oral use

France EG LABO - LABORATOIRES EUROGENERICS "Le Quintet" - bâtiment A 12, rue Danjou 92517 Boulogne Billancourt Cedex France

Ibuprofen IBUPROFENE EG 400 mg, comprimé pelliculé

400 mg Film-coated tablet Oral use

France ELAIAPHARM 2881, Route des Crêtes BP 205 Valbonne 06904 Sophia Antipolis Cedex France

Ibuprofen IBUPROFENE ELAIAPHARM 200 mg, comprimé pelliculé

200 mg Film-coated tablet Oral use

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INN Invented name Strength Pharmaceutical form

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France ETHYPHARM 194, Bureaux de la Colline Bâtiment D 92213 Saint-Cloud Cedex France

Ibuprofen IBUPROFENE ETHYPHARM L.P.300 mg, microgranules à libération prolongée en gélule

300 mg Prolonged-release capsule, hard

Oral use

France EVOLUPHARM rue Irène Caron Zone Industrielle d'Auneuil 60390 Auneuil France

Ibuprofen IBUPROFENE EVOLUGEN 400 mg, comprimé pelliculé

400 mg Film-coated tablet Oral use

France Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofen IBUPROFENE FARMALIDER 400 mg, comprimé pelliculé

400 mg Film-coated tablet Oral use

France GIBAUD PHARMA 73, rue de la Tour 42002 Saint-Etienne Cedex 1 France

Ibuprofen IBUPROFENE GIBAUD 200 mg, comprimé enrobé

200 mg Coated tablet Oral use

France PLUS PHARMACIE 26, boulevard Paul Vaillant-Couturier 94200 Ivry-sur-Seine France

Ibuprofen IBUPROFENE ISOMED 200 mg, comprimé enrobé

200 mg Coated tablet Oral use

France MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France

Ibuprofen IBUPROFENE MYLAN 200 mg, comprimé enrobé

200 mg Coated tablet Oral use

73

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

France MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France

Ibuprofen IBUPROFENE MYLAN 400 mg, comprimé effervescent

400 mg Effervescent tablet Oral use

France MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France

Ibuprofen IBUPROFENE MYLAN 400 mg, comprimé pelliculé

400 mg Film-coated tablet Oral use

France MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France

Ibuprofen IBUPROFENE MYLAN CONSEIL 200 mg, comprimé pelliculé

200 mg Film-coated tablet Oral use

France MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France

Ibuprofen IBUPROFENE MYLAN CONSEIL 400 mg, comprimé pelliculé

400 mg Film-coated tablet Oral use

France LABORATOIRES NEPENTHES 13, avenue Paul Langevin ZA de la patte d'oie 95220 Herblay France

Ibuprofen IBUPROFENE NEPENTHES 200 mg, comprimé pelliculé

200 mg Film-coated tablet Oral use

France LABORATOIRES NEPENTHES 13, avenue Paul Langevin ZA de la patte d'oie 95220 Herblay France

Ibuprofen IBUPROFENE NEPENTHES 400 mg, comprimé pelliculé

400 mg Film-coated tablet Oral use

74

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

France Biogaran Boulevard Charles de Gaulle 15 92700 Colombes France

Ibuprofen IBUPROFENE NOR 400 mg, comprimé pelliculé

400 mg Film-coated tablet Oral use

France Biogaran Boulevard Charles de Gaulle 15 92700 Colombes France

Ibuprofen IBUPROFENE PHR LAB 400 mg, comprimé pelliculé

400 mg Film-coated tablet Oral use

France RANBAXY PHARMACIE GENERIQUES 11-15 Quai Dion Bouton 92800 Puteaux France

Ibuprofen IBUPROFENE RANBAXY MEDICATION OFFICINALE 200 mg, comprimé pelliculé

200 mg Film-coated tablet Oral use

France RANBAXY PHARMACIE GENERIQUES 11-15 Quai Dion Bouton 92800 Puteaux France

Ibuprofen IBUPROFENE RANBAXY MEDICATION OFFICINALE 400 mg, comprimé pelliculé

400 mg Film-coated tablet Oral use

France ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen IBUPROFENE RATIOPHARM 200 mg, comprimé enrobé

200 mg Coated tablet Oral use

75

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

France TEVA SANTE Esplanade du Général de Gaulle 110 92931 Paris La Défense Cedex France

Ibuprofen IBUPROFENE RATIOPHARM 400 mg, comprimé pelliculé

400 mg Film-coated tablet Oral use

France TEVA SANTE Esplanade du Général de Gaulle 110 92931 Paris La Défense Cedex France

Ibuprofen IBUPROFENE RATIOPHARM CONSEIL 200 mg, comprimé enrobé

200 mg Coated tablet Oral use

France TEVA SANTE Esplanade du Général de Gaulle 110 92931 Paris La Défense Cedex France

Ibuprofen IBUPROFENE RATIOPHARM CONSEIL 400 mg, comprimé pelliculé

400 mg Film-coated tablet Oral use

France Biogaran Boulevard Charles de Gaulle 15 92700 Colombes France

Ibuprofen IBUPROFENE REF 200 mg, comprimé pelliculé

200 mg Coated tablet Oral use

France RANBAXY PHARMACIE GENERIQUES 11-15 Quai Dion Bouton 92800 Puteaux France

Ibuprofen IBUPROFENE RPG 400 mg, comprimé pelliculé

400 mg Film-coated tablet Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

France SANDOZ 49, avenue Georges Pompidou 92300 Levallois-Perret France

Ibuprofen IBUPROFENE SANDOZ 200 mg, comprimé enrobé

200 mg Coated tablet Oral use

France SANDOZ 49, avenue Georges Pompidou 92300 Levallois-Perret France

Ibuprofen IBUPROFENE SANDOZ 200 mg, comprimé pelliculé

200 mg Film-coated tablet Oral use

France SANDOZ 49, avenue Georges Pompidou 92300 Levallois-Perret France

Ibuprofen IBUPROFENE SANDOZ 400 mg, comprimé enrobé

400 mg Coated tablet Oral use

France SANDOZ 49, avenue Georges Pompidou 92300 Levallois-Perret France

Ibuprofen IBUPROFENE SANDOZ 400 mg, comprimé pelliculé

400 mg Film-coated tablet Oral use

France SANDOZ 49, avenue Georges Pompidou 92300 Levallois-Perret France

Ibuprofen IBUPROFENE SANDOZ CONSEIL 200 mg, comprimé enrobé

200 mg Coated tablet Oral use

77

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

France SANDOZ 49, avenue Georges Pompidou 92300 Levallois-Perret France

Ibuprofen IBUPROFENE SANDOZ CONSEIL 400 mg, comprimé pelliculé

400 mg Film-coated tablet Oral use

France TEVA SANTE Esplanade du Général de Gaulle 110 92931 Paris La Défense Cedex France

Ibuprofen IBUPROFENE TEVA 200 mg, comprimé enrobé

200 mg Coated tablet Oral use

France TEVA SANTE Esplanade du Général de Gaulle 110 92931 Paris La Défense Cedex France

Ibuprofen IBUPROFENE TEVA 400 mg, comprimé pelliculé

400 mg Film-coated tablet Oral use

France TEVA SANTE Esplanade du Général de Gaulle 110 92931 Paris La Défense Cedex France

Ibuprofen IBUPROFENE TEVA CONSEIL 200 mg, comprimé enrobé

200 mg Coated tablet Oral use

France PFIZER HOLDING FRANCE 23-25, avenue du Docteur Lannelongue 75014 Paris France

Ibuprofen IBUPROFENE UNION INTERPHARMACEUTIQUE ATLANTIQUE 200 mg, comprimé pelliculé

200 mg Film-coated tablet Oral use

78

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

France PFIZER HOLDING FRANCE 23-25, avenue du Docteur Lannelongue 75014 Paris France

Ibuprofen IBUPROFENE UNION INTERPHARMACEUTIQUE ATLANTIQUE 400 mg, comprimé pelliculé

400 mg Film-coated tablet Oral use

France PFIZER HOLDING FRANCE 23-25, avenue du Docteur Lannelongue 75014 Paris France

Ibuprofen IBUPROFENE UPJOHN 200 mg, comprimé pelliculé

200 mg Film-coated tablet Oral use

France PFIZER SANTE FAMILIALE 23-25, avenue du Docteur Lannelongue 75014 Paris France

Ibuprofen IBUPROFENE WYETH SANTE FAMILIALE 400 mg, comprimé effervescent

400 mg Effervescent tablet Oral use

France ZYDUS FRANCE 25, rue des Peupliers ZAC Les Hautes Pâtures - Parc d’Activités des Peupliers 92000 Nanterre France

Ibuprofen IBUPROFENE ZF 400 mg, comprimé pelliculé

400 mg Film-coated tablet Oral use

79

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INN Invented name Strength Pharmaceutical form

Route of administration

France ZYDUS FRANCE 25, rue des Peupliers ZAC Les Hautes Pâtures - Parc d’Activités des Peupliers 92000 Nanterre France

Ibuprofen IBUPROFENE ZYDUS 200 mg, comprimé enrobé

200 mg Coated tablet Oral use

France ZYDUS FRANCE 25, rue des Peupliers ZAC Les Hautes Pâtures - Parc d’Activités des Peupliers 92000 Nanterre France

Ibuprofen IBUPROFENE ZYDUS 400 mg, comprimé pelliculé

400 mg Film-coated tablet Oral use

France ZYDUS FRANCE 25, rue des Peupliers ZAC Les Hautes Pâtures - Parc d’Activités des Peupliers 92000 Nanterre France

Ibuprofen IBUPROFENE ZYDUS FRANCE 200 mg, comprimé pelliculé

200 mg Film-coated tablet Oral use

France ZYDUS FRANCE 25, rue des Peupliers ZAC Les Hautes Pâtures - Parc d’Activités des Peupliers 92000 Nanterre France

Ibuprofen IBUPROFENE ZYDUS FRANCE 400 mg, comprimé pelliculé

400 mg Film-coated tablet Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

France Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen IBUTABS 200 mg, comprimé pelliculé

200 mg Film-coated tablet Oral use

France Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen IBUTABS 400 mg, comprimé pelliculé

400 mg Film-coated tablet Oral use

France URGO 42, rue de Longvic BP 157 21304 Chenôve Cedex France

Ibuprofen INTRALGIS 200 mg, comprimé pelliculé

200 mg Film-coated tablet Oral use

France RECKITT BENCKISER HEALTHCARE FRANCE 15, rue Ampère 91748 Massy Cedex France

Ibuprofen NUREFLEX 200 mg, comprimé enrobé

200 mg Coated tablet Oral use

France RECKITT BENCKISER HEALTHCARE FRANCE 15, rue Ampère 91748 Massy Cedex France

Ibuprofen NUREFLEX 400 mg, comprimé enrobé

400 mg Coated tablet Oral use

France RECKITT BENCKISER HEALTHCARE FRANCE 15, rue Ampère 91748 Massy Cedex France

Ibuprofen NUREFLEX 400 mg, granulés effervescents en sachet-dose

400 mg Effervescent granules Oral use

81

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

France RECKITT BENCKISER HEALTHCARE FRANCE 15, rue Ampère 91748 Massy Cedex France

Ibuprofen NUREFLEX L.P. 300 mg, gélule à libération prolongée

300 mg Prolonged-release capsule, hard

Oral use

France RECKITT BENCKISER HEALTHCARE FRANCE 15, rue Ampère 91748 Massy Cedex France

Ibuprofen NUROFEN 200 mg, capsule molle

200 mg Capsule, soft Oral use

France RECKITT BENCKISER HEALTHCARE FRANCE 15, rue Ampère 91748 Massy Cedex France

Ibuprofen NUROFEN 200 mg, comprimé enrobé

200 mg Coated tablet Oral use

France RECKITT BENCKISER HEALTHCARE FRANCE 15, rue Ampère 91748 Massy Cedex France

Ibuprofen NUROFEN 200 mg, comprimé orodispersible

200 mg Orodispersible tablet Oral use

France RECKITT BENCKISER HEALTHCARE FRANCE 15, rue Ampère 91748 Massy Cedex France

Ibuprofen NUROFEN 400 mg, capsule molle

400 mg Capsule, soft Oral use

82

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

France RECKITT BENCKISER HEALTHCARE FRANCE 15, rue Ampère 91748 Massy Cedex France

Ibuprofen NUROFEN 400 mg, comprimé enrobé

400 mg Coated tablet Oral use

France RECKITT BENCKISER HEALTHCARE FRANCE 15, rue Ampère 91748 Massy Cedex France

Ibuprofen pseudoephedrine

NUROFEN RHUME, comprimé pelliculé

200 mg Film-coated tablet Oral use

France RECKITT BENCKISER HEALTHCARE FRANCE 15, rue Ampère 91748 Massy Cedex France

Ibuprofen NUROFENCAPS 200 mg, capsule molle

200 mg Capsule, soft Oral use

France RECKITT BENCKISER HEALTHCARE FRANCE 15, rue Ampère 91748 Massy Cedex France

Ibuprofen NUROFENCAPS 400 mg, capsule molle

400 mg Capsule, soft Oral use

France RECKITT BENCKISER HEALTHCARE FRANCE 15, rue Ampère 91748 Massy Cedex France

Ibuprofen lysinate NUROFENFEM 400 mg, comprimé pelliculé

400 mg Film-coated tablet Oral use

83

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

France RECKITT BENCKISER HEALTHCARE FRANCE 15, rue Ampère 91748 Massy Cedex France

Ibuprofen NUROFENFLASH 200 mg, comprimé pelliculé

200 mg Film-coated tablet Oral use

France RECKITT BENCKISER HEALTHCARE FRANCE 15, rue Ampère 91748 Massy Cedex France

Ibuprofen NUROFENFLASH 400 mg, comprimé pelliculé

400 mg Film-coated tablet Oral use

France RECKITT BENCKISER HEALTHCARE FRANCE 15, rue Ampère 91748 Massy Cedex France

Ibuprofen NUROFENFLASH 400 mg, poudre pour solution buvable en sachet

400 mg Powder for oral solution

Oral use

France RECKITT BENCKISER HEALTHCARE FRANCE 15, rue Ampère 91748 Massy Cedex France

Ibuprofen NUROFENTABS 200 mg, comprimé orodispersible

200 mg Orodispersible tablet Oral use

France RECKITT BENCKISER HEALTHCARE FRANCE 15, rue Ampère 91748 Massy Cedex France

Ibuprofen NUROFLASH 200 mg, capsule molle

200 mg Capsule, soft Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

France WYETH SANTE FAMILIALE Coeur Défense - Tour A - La Défense 4 110, Esplanade du Général de Gaulle 92931 Paris La Défense Cedex France

Ibuprofen pseudoephedrine

RHINADVIL RHUME IBUPROFENE/PSEUDOEPHEDRINE, comprimé enrobé

200 mg Coated tablet Oral use

France PFIZER SANTE FAMILIALE 23-25, avenue du Docteur Lannelongue 75014 Paris France

Ibuprofen pseudoephedrine

RHINADVILTAB, comprimé enrobé

200 mg Coated tablet Oral use

France RECKITT BENCKISER HEALTHCARE FRANCE 15, rue Ampère 91748 Massy Cedex France

Ibuprofen pseudoephedrine

RHINUREFLEX, comprimé pelliculé

200 mg Film-coated tablet Oral use

France ZAMBON FRANCE 13, rue René Jacques 92138 Issy-les-Moulineaux Cedex France

Ibuprofen SPEDIFEN 200 mg, comprimé

200 mg Tablet Oral use

France ZAMBON FRANCE 13, rue René Jacques 92138 Issy-les-Moulineaux Cedex France

Ibuprofen SPEDIFEN 200 mg, granulés pour solution buvable en sachet-dose

200 mg Granules for oral solution

Oral use

85

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INN Invented name Strength Pharmaceutical form

Route of administration

France ZAMBON FRANCE 13, rue René Jacques 92138 Issy-les-Moulineaux Cedex France

Ibuprofen SPEDIFEN 400 mg, comprimé pelliculé

400 mg Film-coated tablet Oral use

France ZAMBON FRANCE 13, rue René Jacques 92138 Issy-les-Moulineaux Cedex France

Ibuprofen SPEDIFEN 400 mg, granulés pour solution buvable en sachet-dose

400 mg Granules for oral solution

Oral use

France ZAMBON FRANCE 13, rue René Jacques 92138 Issy-les-Moulineaux Cedex France

Ibuprofen SPIFEN 200 mg, comprimé

200 mg Tablet Oral use

France ZAMBON FRANCE 13, rue René Jacques 92138 Issy-les-Moulineaux Cedex France

Ibuprofen SPIFEN 200 mg, granulés pour solution buvable en sachet-dose

200 mg Granules for oral solution

Oral use

France ZAMBON FRANCE 13, rue René Jacques 92138 Issy-les-Moulineaux Cedex France

Ibuprofen SPIFEN 400 mg, comprimé pelliculé

400 mg Film-coated tablet Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

France ZAMBON FRANCE 13, rue René Jacques 92138 Issy-les-Moulineaux Cedex France

Ibuprofen SPIFEN 400 mg, granulés pour solution buvable en sachet-dose

400 mg Granules for oral solution

Oral use

France Bristol Myers Squibb 3, rue Joseph Monier 92500 Rueil-Malmaison France

Ibuprofen UPFEN 200 mg, comprimé pelliculé

200 mg Film-coated tablet Oral use

Germany 1 A Pharma GmbH Keltenring 1 + 3 82041 Oberhaching Germany

Ibuprofen Ibuprofen - 1 A Pharma 20 mg/ml Suspension zum Einnehmen

20 mg Oral suspension Oral use

Germany 1 A Pharma GmbH Keltenring 1 + 3 82041 Oberhaching Germany

Ibuprofen Ibu 600 - 1 A Pharma 600 mg Film-coated tablet Oral use

Germany 1 A Pharma GmbH Keltenring 1 + 3 82041 Oberhaching Germany

Ibuprofen Ibu 400 - 1 A Pharma 400 mg Film-coated tablet Oral use

Germany 1 A Pharma GmbH Keltenring 1 + 3 82041 Oberhaching Germany

Ibuprofen Ibu 400 akut - 1 A Pharma

400 mg Film-coated tablet Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Germany 1 A Pharma GmbH Keltenring 1 + 3 82041 Oberhaching Germany

Ibuprofen Ibu 800 ret - 1 A Pharma

800 mg Prolonged-release tablet

Oral use

Germany 1 A Pharma GmbH Keltenring 1 + 3 82041 Oberhaching Germany

Ibuprofen Ibu 800 - 1 A Pharma 800 mg Film-coated tablet Oral use

Germany 1 A Pharma GmbH Keltenring 1 + 3 82041 Oberhaching Germany

Ibuprofen Ibuprofen - 1 A Pharma 40 mg/ml Suspension zum Einnehmen

40 mg Oral suspension Oral use

Germany Abbott Arzneimittel GmbH Freundallee 9A 30173 Hannover Germany

Ibuprofen Brufen 40 mg/ml Suspension zum Einnehmen

40 mg Oral suspension Oral use

Germany AbZ-Pharma GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen Ibuprofen AbZ 2 % Saft 20 mg/ml Syrup Oral use

Germany AbZ-Pharma GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen Ibuprofen AbZ 600 mg Filmtablette

600 mg Film-coated tablet Oral use

Germany AbZ-Pharma GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen Ibu-Lysin AbZ Migräne 684 mg Filmtabletten

400 mg Film-coated tablet Oral use

88

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Germany AbZ-Pharma GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen Ibuprofen-CT 4 % Kindersaft

40 mg/ml Syrup Oral use

Germany AbZ-Pharma GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen Ibuprofen AbZ 800 mg Filmtabletten

800 mg Film-coated tablet Oral use

Germany AbZ-Pharma GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen Ibu-Lysin-CT 342 mg Filmtabletten

200 mg Film-coated tablet Oral use

Germany AbZ-Pharma GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen Ibuprofen-CT 200 mg Filmtabletten

200 mg Film-coated tablet Oral use

Germany AbZ-Pharma GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen ibuprofen-ct 600 mg Filmtabletten

600 mg Film-coated tablet Oral use

Germany AbZ-Pharma GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen Ibu-Lysin-CT 684 mg Filmtabletten

400 mg Film-coated tablet Oral use

Germany AbZ-Pharma GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen Ibuprofen AbZ 4 % Saft 40 mg/ml Syrup Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Germany AbZ-Pharma GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen ibuprofen-ct 400 mg Filmtablette

400 mg Film-coated tablet Oral use

Germany AbZ-Pharma GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen ibuprofen-ct 500 mg Zäpfchen

500 mg Suppository Rectal use

Germany AbZ-Pharma GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen ibuprofen-ct 400 mg Retardkapsel

400 mg Prolonged-release capsule, hard

Oral use

Germany AbZ-Pharma GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen Ibuprofen-CT 800 mg Retardtabletten

800 mg Prolonged-release tablet

Oral use

Germany acis Arzneimittel GmbH Lil-Dagover-Ring 7 82031 Grünwald Germany

Ibuprofen Ibu-acis 600 mg Filmtabletten

600 mg Film-coated tablet Oral use

Germany acis Arzneimittel GmbH Lil-Dagover-Ring 7 82031 Grünwald Germany

Ibuprofen Ibu-acis 800 mg retard 800 mg Prolonged-release tablet

Oral use

90

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Germany Actavis Deutschland GmbH & Co. KG Willy-Brandt-Allee 2 81829 München Germany

Ibuprofen Ibuprofen-Actavis 600 mg Filmtabletten

600 mg Film-coated tablet Oral use

Germany Actavis Deutschland GmbH & Co. KG Willy-Brandt-Allee 2 81829 München Germany

Ibuprofen Ibuprofen-Actavis Granulat 400 mg

400 mg Granules for oral solution

Oral use

Germany Actavis Deutschland GmbH & Co. KG Willy-Brandt-Allee 2 81829 München Germany

Ibuprofen Ibuprofen-Actavis 400 mg Filmtabletten

400 mg Film-coated tablet Oral use

Germany Actavis Deutschland GmbH & Co. KG Willy-Brandt-Allee 2 81829 München Germany

Ibuprofen Ibuprofen-Actavis Granulat 600 mg

600 mg Granules for oral solution

Oral use

Germany Actavis Deutschland GmbH & Co. KG Willy-Brandt-Allee 2 81829 München Germany

Ibuprofen Ibuprofen-Actavis 800 mg Filmtabletten

800 mg Film-coated tablet Oral use

91

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Germany Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Ibuprofen-Actavis 200 mg Filmtabletten

200 mg Film-coated tablet Oral use

Germany ADL Pharma GmbH Borsigstr. 3 71263 Weil der Stadt Germany

Ibuprofen Ibuprofen PB 400 mg 400 mg Film-coated tablet Oral use

Germany ADL Pharma GmbH Borsigstr. 3 71263 Weil der Stadt Germany

Ibuprofen Ibuprofen PB 600 mg 600 mg Film-coated tablet Oral use

Germany ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 89150 Laichingen Germany

Ibuprofen Ibuprofen AL 40 mg/ml Suspension zum Einnehmen

40 mg Oral suspension Oral use

Germany ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 89150 Laichingen Germany

Ibuprofen Ibuprofen AL 400 400 mg Film-coated tablet Oral use

Germany ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 89150 Laichingen Germany

Ibuprofen Ibuprofen AL 800 retard 800 mg Prolonged-release tablet

Oral use

Germany ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 89150 Laichingen Germany

Ibuprofen Ibuprofen AL 800 800 mg Film-coated tablet Oral use

92

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Germany ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 89150 Laichingen Germany

Ibuprofen Ibuprofen AL 600 600 mg Film-coated tablet Oral use

Germany ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 89150 Laichingen Germany

Ibuprofen natrium Ibuprofen AL 600 Zäpfchen

694 mg Suppository Rectal use

Germany Aspire Pharma Limited 102 High Street GB-GU7 1DS GODALMING, SURREY United Kingdom

Ibuprofen Ibuprofen ASPIRE 40 mg/ml Suspension zum Einnehmen

40 mg Oral suspension Oral use

Germany axcount Generika GmbH Max-Planck-Str. 36d 61381 Friedrichsdorf Germany

Ibuprofen Ibuprofen Axcount 800 mg retard

800 mg Prolonged-release tablet

Oral use

Germany axcount Generika GmbH Max-Planck-Str. 36d 61381 Friedrichsdorf Germany

Ibuprofen Ibuprofen axcount 400 mg akut

400 mg Film-coated tablet Oral use

Germany axcount Generika GmbH Max-Planck-Str. 36d 61381 Friedrichsdorf Germany

Ibuprofen Fibraflex 800 mg 800 mg Film-coated tablet Oral use

93

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Germany axcount Generika GmbH Max-Planck-Str. 36d 61381 Friedrichsdorf Germany

Ibuprofen Ibuprofen axcount 200 mg akut

200 mg Film-coated tablet Oral use

Germany axcount Generika GmbH Max-Planck-Str. 36d 61381 Friedrichsdorf Germany

Ibuprofen Ibuprofen Axcount 600 mg

600 mg Film-coated tablet Oral use

Germany AxiCorp Pharma GmbH Max-Planck-Str. 36b 61381 Friedrichsdorf Germany

Ibuprofen ibutop 400 mg Schmerztabletten

400 mg Film-coated tablet Oral use

Germany AxiCorp Pharma GmbH Max-Planck-Str. 36b 61381 Friedrichsdorf Germany

Ibuprofen ibutop 200 mg Schmerztabletten

200 mg Film-coated tablet Oral use

Germany Bayer Vital GmbH Kaiser-Wilhelm-Allee 70 51373 Leverkusen Germany

Ibuprofen Aktren Spezial 400 mg Capsule, soft Oral use

Germany Bayer Vital GmbH Kaiser-Wilhelm-Allee 70 51373 Leverkusen Germany

Ibuprofen Aktren forte 400 mg Film-coated tablet Oral use

Germany Bayer Vital GmbH Kaiser-Wilhelm-Allee 70 51373 Leverkusen Germany

Ibuprofen Aktren Mobil 400 mg Film-coated tablet Oral use

94

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Germany Bayer Vital GmbH Kaiser-Wilhelm-Allee 70 51373 Leverkusen Germany

Ibuprofen Aktren 200 mg Coated tablet Oral use

Germany Bayer Vital GmbH Kaiser-Wilhelm-Allee 70 51373 Leverkusen Germany

Ibuprofen Aktren 200 mg Coated tablet Oral use

Germany bene - Arzneimittel GmbH Herterichstr. 1 - 3 81479 München Germany

Ibuprofen ib-u-ron 75 mg Zäpfchen

75 mg Suppository Rectal use

Germany bene - Arzneimittel GmbH Herterichstr. 1 - 3 81479 München Germany

Ibuprofen Ibuprofen bene 150 mg Zäpfchen

150 mg Suppository Rectal use

Germany Dolorgiet GmbH & Co. KG Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany

Ibuprofen ib-u-ron akut 400 mg Weichkapseln

400 mg Capsule, soft Oral use

Germany bene - Arzneimittel GmbH Herterichstr. 1 - 3 81479 München Germany

Ibuprofen ib-u-ron 150 mg Zäpfchen

150 mg Suppository Rectal use

Germany bene - Arzneimittel GmbH Herterichstr. 1 - 3 81479 München Germany

Ibuprofen Ibuprofen bene 75 mg Zäpfchen

75 mg Suppository Rectal use

95

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Germany Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany

Ibuprofen EUDORLIN Extra Ibuprofen-Schmerztabletten

400 mg Film-coated tablet Oral use

Germany Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany

Ibuprofen MENSOTON gegen Regelschmerzen

200 mg Film-coated tablet Oral use

Germany Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany

Ibuprofen Eudorlin Ibuprofen 40 mg/ml Suspension zum Einnehmen

40 mg/ml Oral suspension Oral use

Germany Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany

Ibuprofen Eudorlin Ibuprofen 20 mg/ml Suspension zum Einnehmen

20 mg/ml Oral suspension Oral use

Germany Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany

Ibuprofen EUDORLIN Migräne 400 mg Film-coated tablet Oral use

Germany betapharm Arzneimittel GmbH Kobelweg 95 86156 Augsburg Germany

Ibuprofen Ibubeta retard 800 mg Prolonged-release tablet

Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Germany betapharm Arzneimittel GmbH Kobelweg 95 86156 Augsburg Germany

Ibuprofen Ibubeta 800 800 mg Film-coated tablet Oral use

Germany betapharm Arzneimittel GmbH Kobelweg 95 86156 Augsburg Germany

Ibuprofen Ibubeta 600 600 mg Film-coated tablet Oral use

Germany betapharm Arzneimittel GmbH Kobelweg 95 86156 Augsburg Germany

Ibuprofen Ibubeta 400 400 mg Film-coated tablet Oral use

Germany Blanco-Pharma GmbH Oasenweg 3 25474 Ellerbek Germany

Ibuprofen Ibusan 400 mg Filmtabletten

400 mg Film-coated tablet Oral use

Germany Boehringer Ingelheim International GmbH Binger Str. 148 - 173 55216 Ingelheim Germany

Ibuprofen Ibuprofen Boehringer Ingelheim 400 mg Weichkapsel

400 mg Capsule, soft Oral use

97

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Germany Boehringer Ingelheim International GmbH Binger Str. 148 - 173 55216 Ingelheim Germany

Ibuprofen pseudoephedrine hydrochloride

BoxaGrippal 200 mg/ 30 mg

200 mg 30 mg

Film-coated tablet Oral use

Germany Boehringer Ingelheim Pharma GmbH & Co. KG Binger Str. 148 - 173 55216 Ingelheim Germany

Ibuprofen Thomapyrin TENSION 400 mg Film-coated tablet Oral use

Germany Boehringer Ingelheim Pharma GmbH & Co. KG Binger Str. 148 - 173 55216 Ingelheim Germany

Ibuprofen TOMIBU 400 mg Film-coated tablet Oral use

Germany Bronzactiv Pharma GmbH Carl-von-Linde-Str. 30 85716 Unterschleißheim Germany

Ibuprofen lysine Ibuaktiv 200 mg 342 mg Effervescent tablet Oral use

Germany Denk Pharma GmbH & Co. KG Prinzregentenstr. 79 81675 München Germany

Ibuprofen Ibuprofen Denk 600 mg Filmtabletten

600 mg Film-coated tablet Oral use

98

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Germany Omega Pharma Deutschland GmbH Benzstr. 25 71083 Herrenberg Germany

Ibuprofen Optalidon Ibu 200 mg 200 mg Film-coated tablet Oral use

Germany Dexcel Pharma GmbH Carl-Zeiss-Str. 2 63755 Alzenau Germany

Ibuprofen Ibu Atid 400 mg Filmtabletten

400 mg Film-coated tablet Oral use

Germany Dexcel Pharma GmbH Carl-Zeiss-Str. 2 63755 Alzenau Germany

Ibuprofen IbuDex 400 mg 400 mg Film-coated tablet Oral use

Germany Dexcel Pharma GmbH Carl-Zeiss-Str. 2 63755 Alzenau Germany

Ibuprofen Ibuprofen Atid 600 mg 600 mg Film-coated tablet Oral use

Germany Dexcel Pharma GmbH Carl-Zeiss-Str. 2 63755 Alzenau Germany

Ibuprofen Ibuprofen Atid 800 mg 800 mg Film-coated tablet Oral use

Germany Dexcel Pharma GmbH Carl-Zeiss-Str. 2 63755 Alzenau Germany

Ibuprofen IbuDex 200 mg 200 mg Film-coated tablet Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Germany Dolorgiet GmbH & Co. KG Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany

Ibuprofen Dolgit Schmerzdragees 200 mg Coated tablet Oral use

Germany Dolorgiet GmbH & Co. KG Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany

Ibuprofen Schmerz-Dolgit 400 mg Capsule, soft Oral use

Germany Dolorgiet GmbH & Co. KG Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany

Ibuprofen Dolgit 200 200 mg Coated tablet Oral use

Germany Dolorgiet GmbH & Co. KG Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany

Ibuprofen Dolgit 800 800 mg Coated tablet Oral use

Germany Dolorgiet GmbH & Co. KG Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany

Ibuprofen Dolgit 400 400 mg Coated tablet Oral use

Germany Dolorgiet GmbH & Co. KG Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany

Ibuprofen Dolgit Schmerzkapseln gegen Schmerzen und Fieber

400 mg Capsule, soft Oral use

Germany Dolorgiet GmbH & Co. KG Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany

Ibuprofen Dolgit 600 600 mg Coated tablet Oral use

100

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Germany Dr. R. Pfleger Chemische Fabrik GmbH Dr.-Robert-Pfleger-Str. 12 96052 Bamberg Germany

Ibuprofen Gyno-Neuralgin 400 mg Film-coated tablet Oral use

Germany Dr. R. Pfleger Chemische Fabrik GmbH Dr.-Robert-Pfleger-Str. 12 96052 Bamberg Germany

Ibuprofen Neuralgin extra Ibu-Lysinat

400 mg Coated tablet Oral use

Germany Dr. R. Pfleger Chemische Fabrik GmbH Dr.-Robert-Pfleger-Str. 12 96052 Bamberg Germany

Ibuprofen Ibuprofen Pfleger 400 mg Filmtabletten

400 mg Coated tablet Oral use

Germany Dr. Kade Pharmazeutische Fabrik GmbH Rigistr. 2 12277 Berlin Germany

Ibuprofen Urem forte 400 mg Coated tablet Oral use

101

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Germany Dr. Kade Pharmazeutische Fabrik GmbH Rigistr. 2 12277 Berlin Germany

Ibuprofen Ibu KD 400 mg 400 mg Coated tablet Oral use

Germany Dr. Kade Pharmazeutische Fabrik GmbH Rigistr. 2 12277 Berlin Germany

Ibuprofen Ibu KD 800 mg 800 mg Coated tablet Oral use

Germany Dr. Kade Pharmazeutische Fabrik GmbH Rigistr. 2 12277 Berlin Germany

Ibuprofen Ibu KD 600 mg 600 mg Coated tablet Oral use

Germany Dr. Kade Pharmazeutische Fabrik GmbH Rigistr. 2 12277 Berlin Germany

Ibuprofen Ibu KD 400 mg akut 400 mg Coated tablet Oral use

Germany Fair-Med Healthcare GmbH Planckstr. 13 22765 Hamburg Germany

Ibuprofen Ibuprofen FAIR-MED Healthcare 600 mg Filmtabletten

600 mg Film-coated tablet Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Germany Fair-Med Healthcare GmbH Planckstr. 13 22765 Hamburg Germany

Ibuprofen Ibuprofen FAIR-MED Healthcare 400 mg Filmtabletten

400 mg Film-coated tablet Oral use

Germany Fair-Med Healthcare GmbH Planckstr. 13 22765 Hamburg Germany

Ibuprofen Ibuprofen FAIR-MED Healthcare 200 mg Filmtabletten

200 mg Film-coated tablet Oral use

Germany Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofen Ibuprofen LIDERFARM 20 mg/ml Suspension zum Einnehmen

20 mg/ml Oral suspension Oral use

Germany Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofen Ibuprofen LIDERFARM 40 mg/ml Suspension zum Einnehmen

40 mg/ml Oral suspension Oral use

Germany Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofen Ibuprofen LIDERFARM 40 mg/ml Suspension zum Einnehmen

40 mg/ml Oral suspension Oral use

Germany Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofen Ibuprofen LIDERFARM 40 mg/ml Suspension zum Einnehmen

40 mg/ml Oral suspension Oral use

Germany Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofen Ibuprofen LIDERFARM 20 mg/ml Suspension zum Einnehmen

20 mg/ml Oral suspension Oral use

103

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Germany Galpharm Healthcare Limited EX33 2DL Wrafton Braunton Devon United Kingdom

Ibuprofen Ibuprofen Galpharm 400 mg Filmtabletten

400 mg Film-coated tablet Oral use

Germany Galpharm Healthcare Limited EX33 2DL Wrafton Braunton Devon United Kingdom

Ibuprofen Ibuprofen Galpharm 200 mg Filmtabletten

200 mg Film-coated tablet Oral use

Germany Gebro Pharma GmbH Bahnhofbichl 13 6391 Fieberbrunn Austria

Dexibuprofen Dolomagon 400 mg Filmtabletten

400 mg Film-coated tablet Oral use

Germany Gebro Pharma GmbH Bahnhofbichl 13 6391 Fieberbrunn Austria

Dexibuprofen Dolomagon 300 mg Filmtabletten

300 mg Film-coated tablet Oral use

Germany Georg Simons GmbH Eckenheimer Landstr. 100-104 60318 Frankfurt am Main Germany

Ibuprofen Dismenol N 200 mg Film-coated tablet Oral use

104

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Germany Hemopharm GmbH Königsteiner Str. 2 61350 Bad Homburg v.d.H. Germany

Ibuprofen lysine Ibu-Hemopharm 200mg Brausetabletten

342 mg Effervescent tablet Oral use

Germany Hemopharm GmbH Königsteiner Str. 2 61350 Bad Homburg v.d.H. Germany

Ibuprofen Ibu-Hemopharm 400mg Filmtabletten

400 mg Film-coated tablet Oral use

Germany Hennig Arzneimittel GmbH & Co. KG Liebigstr. 1 65439 Flörsheim Germany

Ibuprofen Esprenit 800 mg retard Retardtabletten

800 mg Prolonged-release tablet

Oral use

Germany Hennig Arzneimittel GmbH & Co. KG Liebigstr. 1 65439 Flörsheim Germany

Ibuprofen Esprenit 600mg Filmtabletten

600 mg Film-coated tablet Oral use

Germany Hennig Arzneimittel GmbH & Co. KG Liebigstr. 1 65439 Flörsheim Germany

Ibuprofen Esprenit 400mg Filmtabletten

400 mg Film-coated tablet Oral use

Germany Heumann Pharma GmbH & Co. Generika KG Südwestpark 50 90449 Nürnberg Germany

Ibuprofen Ibuprofen Heumann Schmerztabletten 400mg Filmtabletten

400 mg Film-coated tablet Oral use

105

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Germany Heumann Pharma GmbH & Co. Generika KG Südwestpark 50 90449 Nürnberg Germany

Ibuprofen Ibuprofen Heumann 800mg Filmtabletten

800 mg Film-coated tablet Oral use

Germany Heumann Pharma GmbH & Co. Generika KG Südwestpark 50 90449 Nürnberg Germany

Ibuprofen Ibuprofen Heumann 200mg Filmtabletten

200 mg Film-coated tablet Oral use

Germany Heumann Pharma GmbH & Co. Generika KG Südwestpark 50 90449 Nürnberg Germany

Ibuprofen Ibuprofen Heumann 600mg Filmtabletten

600 mg Film-coated tablet Oral use

Germany Hexal AG Industriestr. 25 83607 Holzkirchen Germany

Ibuprofen Ibu-LysinHexal 684 mg Filmtabletten

400 mg Film-coated tablet Oral use

Germany Hexal AG Industriestr. 25 83607 Holzkirchen Germany

Ibuprofen Ibuhexal 400 400 mg Film-coated tablet Oral use

Germany Hexal AG Industriestr. 25 83607 Holzkirchen Germany

Ibuprofen sodium Ibuhexal 600 694 mg Suppository Rectal use

106

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Germany Hexal AG Industriestr. 25 83607 Holzkirchen Germany

Ibuprofen Ibuhexal 800 800 mg Film-coated tablet Oral use

Germany Hexal AG Industriestr. 25 83607 Holzkirchen Germany

Ibuprofen Ibuhexal 600 600 mg Film-coated tablet Oral use

Germany Hexal AG Industriestr. 25 83607 Holzkirchen Germany

Ibuprofen Ibuhexal retard 800 mg Prolonged-release tablet

Oral use

Germany KSK-Pharma Vertriebs AG Finkenstr. 1 76327 Pfinztal-Berghausen Germany

Ibuprofen ibu 200 KSK 200 mg Film-coated tablet Oral use

Germany KSK-Pharma Vertriebs AG Finkenstr. 1 76327 Pfinztal-Berghausen Germany

Ibuprofen ibu-KSK 600mg 600 mg Film-coated tablet Oral use

Germany McNeil GmbH & Co.oHG Johnson & Johnson Platz 2 41470 Neuss Germany

Ibuprofen Dolormin Schmerztabletten

200 mg Film-coated tablet Oral use

Germany McNeil GmbH & Co.oHG Johnson & Johnson Platz 2 41470 Neuss Germany

Ibuprofen Dolormin Migräne schnell lösliches Granulat

200 mg Effervescent granules Oral use

107

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Germany McNeil GmbH & Co.oHG Johnson & Johnson Platz 2 41470 Neuss Germany

Ibuprofen Dolormin bei Erkältungsschmerzen und Fieber

200 mg Effervescent granules Oral use

Germany McNeil GmbH & Co.oHG Johnson & Johnson Platz 2 41470 Neuss Germany

Ibuprofen Dolormin Schmerztabletten

342 mg Film-coated tablet Oral use

Germany McNeil GmbH & Co.oHG Johnson & Johnson Platz 2 41470 Neuss Germany

Ibuprofen sodium Dolormin Migräne Zäpfchen

694 mg Suppository Rectal use

Germany McNeil GmbH & Co.oHG Johnson & Johnson Platz 2 41470 Neuss Germany

Ibuprofen Tispol Ibu-DD 400 mg Film-coated tablet Oral use

Germany McNeil GmbH & Co.oHG Johnson & Johnson Platz 2 41470 Neuss Germany

Ibuprofen Ibu 342 Lysinat JJ 342 mg Film-coated tablet Oral use

Germany McNeil GmbH & Co.oHG Johnson & Johnson Platz 2 41470 Neuss Germany

Ibuprofen Dolormin Migräne Filmtabletten

400 mg Film-coated tablet Oral use

Germany McNeil GmbH & Co.oHG Johnson & Johnson Platz 2 41470 Neuss Germany

Ibuprofen Dolormin instant schnell lösliches Granulat

200 mg Effervescent granules Oral use

108

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Germany McNeil GmbH & Co.oHG Johnson & Johnson Platz 2 41470 Neuss Germany

Ibuprofen lysine Dolormin extra 684 mg Film-coated tablet Oral use

Germany McNeil GmbH & Co.oHG Johnson & Johnson Platz 2 41470 Neuss Germany

Ibuprofen lysine Dolormin extra 684 mg Film-coated tablet Oral use

Germany Medphano Arzneimittel GmbH Maienbergstr. 10-12 15562 Rüdersdorf Germany

Ibuprofen Ibuprofen-mp 600 600 mg Film-coated tablet Oral use

Germany Medphano Arzneimittel GmbH Maienbergstr. 10-12 15562 Rüdersdorf Germany

Ibuprofen Miralgin 400 mg Filmtabletten

400 mg Film-coated tablet Oral use

Germany Mepha Investigacao, Desenvolvimento e Fabricacao Farmaceutica, Lda. Lagos Park, Edificio 5A, Piso 2 2740-298 PORTO SALVO Portugal

Ibuprofen Irfen 200 mg Filmtabletten

200 mg Film-coated tablet Oral use

109

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Germany Mepha Investigacao, Desenvolvimento e Fabricacao Farmaceutica, Lda. Lagos Park, Edificio 5A, Piso 2 2740-298 PORTO SALVO Portugal

Ibuprofen Irfen 400 mg Filmtabletten

400 mg Film-coated tablet Oral use

Germany Mibe GmbH Arzneimittel Münchener Str. 15 06796 Brehna Germany

Ibuprofen Fibraflex 600 mg 600 mg Film-coated tablet Oral use

Germany Mibe GmbH Arzneimittel Münchener Str. 15 06796 Brehna Germany

Ibuprofen Jenaprofen 600 mg 600 mg Film-coated tablet Oral use

Germany Mibe GmbH Arzneimittel Münchener Str. 15 06796 Brehna Germany

Ibuprofen Fibraflex 800 mg retard 800 mg Prolonged-release tablet

Oral use

Germany Mibe GmbH Arzneimittel Münchener Str. 15 06796 Brehna Germany

Ibuprofen Fibraflex 400 mg 400 mg Film-coated tablet Oral use

Germany Mibe GmbH Arzneimittel Münchener Str. 15 06796 Brehna Germany

Ibuprofen Jenaprofen 400 mg 400 mg Film-coated tablet Oral use

110

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Germany Mylan dura GmbH Wittichstr. 6 64295 Darmstadt Germany

Ibuprofen Ibuprofen dura 800 mg Filmtabletten

800 mg Film-coated tablet Oral use

Germany Mylan dura GmbH Wittichstr. 6 64295 Darmstadt Germany

Ibuprofen Ibuprofen dura 400 mg Filmtabletten

400 mg Film-coated tablet Oral use

Germany Mylan dura GmbH Wittichstr. 6 64295 Darmstadt Germany

Ibuprofen Ibuprofen dura 600mg Filmtabletten

600 mg Film-coated tablet Oral use

Germany Pfizer Consumer Healthcare GmbH Linkstr. 10 10785 Berlin Germany

Ibuprofen Spalt Kopfschmerz 200 mg Capsule, soft Oral use

Germany Pfizer Consumer Healthcare GmbH Linkstr. 10 10785 Berlin Germany

Ibuprofen Spalt Migräne 400 mg Capsule, soft Oral use

Germany Pfizer Consumer Healthcare GmbH Linkstr. 10 10785 Berlin Germany

Ibuprofen Spalt Mobil 400 mg Capsule, soft Oral use

111

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Germany Pfizer Consumer Healthcare GmbH Linkstr. 10 10785 Berlin Germany

Ibuprofen pseudoephedrine hydrochloride

SpaltGrippal 30 mg/200 mg überzogene Tabletten

200 mg 30 mg

Film-coated tablet Oral use

Germany Pfizer Consumer Healthcare GmbH Linkstr. 10 10785 Berlin Germany

Ibuprofen Spalt Forte 400 mg Capsule, soft Oral use

Germany ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen Ibuprofen-ratio 200 mg Filmtabletten

200 mg Film-coated tablet Oral use

Germany ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen Ibu-ratiopharm 800 mg Retardtabletten

800 mg Prolonged-release tablet

Oral use

Germany ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen Ibu-ratiopharm 400 mg akut Schmerztabletten

400 mg Film-coated tablet Oral use

Germany ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen Ibu-ratiopharm 800 mg Filmtabletten

800 mg Film-coated tablet Oral use

112

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Germany ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen lysine IBU-LYSIN-ratiopharm 342 mg Filmtabletten

342 mg Film-coated tablet Oral use

Germany ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen IBU-ratiopharm Fiebersaft für Kinder 2 %

20 mg/ml Syrup oral use

Germany ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen IBU-ratiopharm Fiebersaft für Kinder 4 %

40 mg/ml Syrup oral use

Germany ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen lysine IBU-ratiopharm Lysinat Schmerztabletten 500 mg

500 mg Film-coated tablet Oral use

Germany ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen lysine IBU-LYSIN-ratiopharm 684 mg Filmtabletten

684 mg Film-coated tablet Oral use

Germany ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen Ibu-ratiopharm 600 mg Filmtabletten

600 mg Film-coated tablet Oral use

Germany ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen Ibuprofen-ratio 400 mg Filmtabletten

400 mg Film-coated tablet Oral use

113

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Germany ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen Ibu-ratiopharm 400 mg Filmtabletten

400 mg Film-coated tablet Oral use

Germany Reckitt Benckiser Deutschland GmbH Theodor-Heuss-Anlage 12 68165 Mannheim Germany

Ibuprofen Nurofen Ibuprofen 400 mg überzogene Tabletten

400 mg Coated tablet Oral use

Germany Reckitt Benckiser Deutschland GmbH Theodor-Heuss-Anlage 12 68165 Mannheim Germany

Ibuprofen Nurofen 40 mg/ml Suspension zum Einnehmen

40 mg/ml Oral suspension Oral use

Germany Reckitt Benckiser Deutschland GmbH Theodor-Heuss-Anlage 12 68165 Mannheim Germany

Ibuprofen Nurofen Liquid 200 mg Weichkapseln

200 mg Capsule, soft Oral use

Germany Reckitt Benckiser Deutschland GmbH Theodor-Heuss-Anlage 12 68165 Mannheim Germany

Ibuprofen Nurofen 200 mg Schmelztabletten Mint

200 mg Orodispersible tablet Oral use

114

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Germany Reckitt Benckiser Deutschland GmbH Theodor-Heuss-Anlage 12 68165 Mannheim Germany

Ibuprofen Nurofen 200 mg Schmelztabletten Lemon

200 mg Orodispersible tablet Oral use

Germany Reckitt Benckiser Deutschland GmbH Theodor-Heuss-Anlage 12 68165 Mannheim Germany

Ibuprofen lysine Nurofen Immedia 400 mg Pulver zur Herstellung einer Lösung zum Einnehmen

683,34 mg Powder for oral solution

Oral use

Germany Reckitt Benckiser Deutschland GmbH Theodor-Heuss-Anlage 12 68165 Mannheim Germany

Ibuprofen Nurofen Schmerz- und Fiebersaft Erdbeer 40 mg/ml Suspension zum Einnehmen

40 mg/ml Oral suspension Oral use

Germany Reckitt Benckiser Deutschland GmbH Theodor-Heuss-Anlage 12 68165 Mannheim Germany

Ibuprofen Nurofen Immedia 200 mg Weichkapseln

200 mg Capsule, soft Oral use

Germany Reckitt Benckiser Deutschland GmbH Theodor-Heuss-Anlage 12 68165 Mannheim Germany

Ibuprofen lysine Nurofen Immedia 400 mg Filmtabletten

684 mg Film-coated tablet Oral use

115

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Germany Recordati Pharma GmbH Eberhard-Finckh-Str. 55 89075 Ulm Germany

Ibuprofen lysine Imbun Zäpfchen 500 mg Suppository Rectal use

Germany Recordati Pharma GmbH Eberhard-Finckh-Str. 55 89075 Ulm Germany

Ibuprofen Imbun retard 800 mg Prolonged-release tablet

Oral use

Germany Recordati Pharma GmbH Eberhard-Finckh-Str. 55 89075 Ulm Germany

Ibuprofen lysine Imbun 500mg Filmtabletten

500 mg Film-coated tablet Oral use

Germany Recordati Pharma GmbH Eberhard-Finckh-Str. 55 89075 Ulm Germany

Ibuprofen lysine Imbun 1000mg Filmtabletten

1000 mg Film-coated tablet Oral use

Germany Recordati Pharma GmbH Eberhard-Finckh-Str. 55 89075 Ulm Germany

Ibuprofen Imbun 800 mg Retardtabletten

800 mg Prolonged-release tablet

Oral use

Germany Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 83607 Holzkirchen Germany

Ibuprofen Ibuprofen Sandoz 800 mg Retardtabletten

800 mg Prolonged-release tablet

Oral use

116

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Germany Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 83607 Holzkirchen Germany

Ibuprofen Anco 600mg Filmtabletten

600 mg Film-coated tablet Oral use

Germany Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 83607 Holzkirchen Germany

Ibuprofen Ibuprofen Sandoz 600 mg Filmtabletten

600 mg Film-coated tablet Oral use

Germany STADA Arzneimittel AG Stadastr. 2-18 61118 Bad Vilbel Germany

Ibuprofen Ibusustad 40 mg/ml Suspension zum Einnehmen

40 mg Oral suspension Oral use

Germany STADA GmbH Stadastr. 2-18 61118 Bad Vilbel Germany

Ibuprofen Ibudolor 400 mg Filmtabletten

400 mg Film-coated tablet Oral use

Germany STADA GmbH Stadastr. 2-18 61118 Bad Vilbel Germany

Ibuprofen Ibudolor 200 mg Filmtabletten

200 mg Film-coated tablet Oral use

Germany STADA GmbH Stadastr. 2-18 61118 Bad Vilbel Germany

Ibuprofen Ibudolor 40 mg/ml Suspension zum Einnehmen

40 mg Oral suspension Oral use

117

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Germany STADA GmbH Stadastr. 2-18 61118 Bad Vilbel Germany

Ibuprofen Pfeil Zahnschmerz-Tabletten forte 400mg Filmtabletten

400 mg Film-coated tablet Oral use

Germany Stadapharm GmbH Stadastr. 2-18 61118 Bad Vilbel Germany

Ibuprofen Ibuprofen STADA 40 mg/ml Suspension zum Einnehmen

40 mg Oral suspension Oral use

Germany Stadapharm GmbH Stadastr. 2-18 61118 Bad Vilbel Germany

Ibuprofen Ibuprofen Stada 600 mg Filmtabletten

600 mg Film-coated tablet Oral use

Germany Stadapharm GmbH Stadastr. 2-18 61118 Bad Vilbel Germany

Ibuprofen Ibuprofen STADA 400mg Filmtabletten

400 mg Film-coated tablet Oral use

Germany Stadapharm GmbH Stadastr. 2-18 61118 Bad Vilbel Germany

Ibuprofen sodium Ibuprofen STADA 600 mg Zäpfchen

694 mg Suppository Rectal use

Germany Stadapharm GmbH Stadastr. 2-18 61118 Bad Vilbel Germany

Ibuprofen Ibuprofen STADA 800 mg Retardtabletten

800 mg Prolonged-release tablet

Oral use

Germany Strathmann GmbH & Co. KG Sellhopsweg 1 22459 Hamburg Germany

Dexibuprofen Deltaran 200 mg Filmtabletten

200 mg Film-coated tablet Oral use

118

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Germany Strathmann GmbH & Co. KG Sellhopsweg 1 22459 Hamburg Germany

Dexibuprofen Deltaran 300 mg Filmtabletten

300 mg Film-coated tablet Oral use

Germany Strathmann GmbH & Co. KG Sellhopsweg 1 22459 Hamburg Germany

Dexibuprofen Deltaran 400 mg Filmtabletten

400 mg Film-coated tablet Oral use

Germany TAD Pharma GmbH Heinz-Lohmann-Str. 5 27472 Cuxhaven Germany

Ibuprofen ibuTAD 800mg retard 800 mg Prolonged-release tablet

Oral use

Germany TAD Pharma GmbH Heinz-Lohmann-Str. 5 27472 Cuxhaven Germany

Ibuprofen ibuTAD 600mg 600 mg Film-coated tablet Oral use

Germany TAD Pharma GmbH Heinz-Lohmann-Str. 5 27472 Cuxhaven Germany

Ibuprofen IbuTAD 800mg 800 mg Film-coated tablet Oral use

Germany TAD Pharma GmbH Heinz-Lohmann-Str. 5 27472 Cuxhaven Germany

Ibuprofen IbuTAD 400 mg gegen Schmerzen

400 mg Film-coated tablet Oral use

Germany TAD Pharma GmbH Heinz-Lohmann-Str. 5 27472 Cuxhaven Germany

Ibuprofen ibuTAD 400mg 400 mg Film-coated tablet Oral use

119

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Germany Temmler Pharma GmbH & Co. KG Temmlerstr. 2 35039 Marburg Germany

Ibuprofen Novogent 400mg Trinktabletten

400 mg Dispersible tablet Oral use

Germany Temmler Pharma GmbH & Co. KG Temmlerstr. 2 35039 Marburg Germany

Ibuprofen Ibuprofen Temmler 200 mg

200 mg Tablet Oral use

Germany Temmler Pharma GmbH & Co. KG Temmlerstr. 2 35039 Marburg Germany

Ibuprofen Novogent 600mg Trinktabletten

600 mg Tablet Oral use

Germany Temmler Pharma GmbH & Co. KG Temmlerstr. 2 35039 Marburg Germany

Ibuprofen Ibuprofen Temmler 400 mg

400 mg Soluble tablet Oral use

Germany Temmler Pharma GmbH & Co. KG Temmlerstr. 2 35039 Marburg Germany

Ibuprofen Novogent 800mg Trinktabletten

800 mg Tablet Oral use

120

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Germany Temmler Werke GmbH Weihenstephaner Str. 28 81673 München Germany

Ibuprofen Ibuflam 800 mg Retardtabletten

800 mg Prolonged-release tablet

Oral use

Germany Temmler Werke GmbH Weihenstephaner Str. 28 81673 München Germany

Ibuprofen dolomo-IBU TN 400 mg 600 mg

Film-coated tablet Oral use

Germany Temmler Werke GmbH Weihenstephaner Str. 28 81673 München Germany

Ibuprofen Ibuprofen Klinge 600mg

600 mg Film-coated tablet Oral use

Germany Temmler Werke GmbH Weihenstephaner Str. 28 81673 München Germany

Ibuprofen Ibuklaph 800 mg 800 mg Film-coated tablet Oral use

Germany TEOFARMA S.R.L. Via F.Ili Cervi 8 27010 Valle Salimbene Italia

Ibuprofen Tabalon 400mg 400 mg Film-coated tablet Oral use

Germany Togal-Werk AG Kardinal-Faulhaber-Str. 5 80333 München Germany

Ibuprofen Togal Ibuprofen AKUT 400mg Filmtabletten

400 mg Film-coated tablet Oral use

Germany TUSSIN Pharma GmbH Menchestr. 22a 35274 Kirchhain Germany

Ibuprofen Ibu-Attritin forte 600 mg Film-coated tablet Oral use

121

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Germany TUSSIN Pharma GmbH Menchestr. 22a 35274 Kirchhain Germany

Ibuprofen Ibu-Attritin N 400 mg Film-coated tablet Oral use

Germany Procter & Gamble Service GmbH Zweigniederlassung Wick Pharma Sulzbacher Str. 40 65824 Schwalbach / Taunus Germany

Ibuprofen pseudoephedrine hydrochloride

WICK DuoGrippal 200mg/30 mg Filmtabletten

200 mg 30 mg

Film-coated tablet Oral use

Germany Winthrop Arzneimittel GmbH Brüningstr. 50 65926 Frankfurt am Main Germany

Ibuprofen Ibuflam 400mg Lichtenstein

400 mg Film-coated tablet Oral use

Germany Winthrop Arzneimittel GmbH Brüningstr. 50 65926 Frankfurt am Main Germany

Ibuprofen Ibuflam 600mg Lichtenstein

600 mg Film-coated tablet Oral use

Germany Winthrop Arzneimittel GmbH Brüningstr. 50 65926 Frankfurt am Main Germany

Ibuprofen Ibuflam-Lysin 400 mg Filmtabletten

400 mg Film-coated tablet Oral use

Germany Winthrop Arzneimittel GmbH Brüningstr. 50 65926 Frankfurt am Main Germany

Ibuprofen Ibuflam 4% 200 mg Oral suspension Oral use

122

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Germany Winthrop Arzneimittel GmbH Brüningstr. 50 65926 Frankfurt am Main Germany

Ibuprofen Ibuflam akut 400 mg Filmtabletten

400 mg Film-coated tablet Oral use

Germany Winthrop Arzneimittel GmbH Brüningstr. 50 65926 Frankfurt am Main Germany

Ibuprofen Ibuflam 800mg Lichtenstein

800 mg Film-coated tablet Oral use

Germany Winthrop Arzneimittel GmbH Brüningstr. 50 65926 Frankfurt am Main Germany

Ibuprofen Ibuflam Kindersaft 2% gegen Fieber und Schmerzen

100 mg oral suspension oral use

Germany Wörwag Pharma GmbH & Co. KG Calwer Str. 7 71034 Böblingen Germany

Ibuprofen Dignoflex 400 400 mg Film-coated tablet Oral use

Germany Wörwag Pharma GmbH & Co. KG Calwer Str. 7 71034 Böblingen Germany

Ibuprofen Dignoflex 600 400 mg Film-coated tablet Oral use

Germany Wörwag Pharma GmbH & Co. KG Calwer Str. 7 71034 Böblingen Germany

Ibuprofen Dignoflex 800 retard 800 mg Prolonged-release tablet

Oral use

123

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Germany Wörwag Pharma GmbH & Co. KG Calwer Str. 7 71034 Böblingen Germany

Ibuprofen Dignoflex 400mg retard 400 mg Prolonged-release tablet

Oral use

Germany Wrafton Laboratories Limited EX33 2DL Wrafton Braunton Devon Great Britain

Ibuprofen Ibuprofen Perrigo 200 mg Filmtabletten

200 mg Film-coated tablet Oral use

Germany Wrafton Laboratories Limited EX33 2DL Wrafton Braunton Devon Great Britain

Ibuprofen Ibuprofen Perrigo 400 mg Filmtabletten

400 mg Film-coated tablet Oral use

Germany Zambon GmbH Fraunhoferstr. 18b 82152 Planegg-Martinsried Germany

Ibuprofen SPIDIFEN 400 mg Filmtabletten

400 mg Film-coated tablet Oral use

Greece Abbott Laboratories Ellas ABEE Agiou Dimitriou 63 174 56 Alimos Greece

Ibuprofen BRUFEN 400 mg Coated tablet Oral use

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INN Invented name Strength Pharmaceutical form

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Greece Abbott Laboratories Ellas ABEE Agiou Dimitriou 63 174 56 Alimos Greece

Ibuprofen BRUFEN 800 mg Film-coated tablet Oral use

Greece Abbott Laboratories Ellas ABEE Agiou Dimitriou 63 174 56 Alimos Greece

Ibuprofen BRUFEN 800 mg Slow-release film-coated tablet

Oral use

Greece Abbott Laboratories Ellas ABEE Agiou Dimitriou 63 174 56 Alimos Greece

Ibuprofen BRUFEN 100 mg/5ml Syrup Oral use

Greece Abbott Laboratories Ellas ABEE Agiou Dimitriou 63 174 56 Alimos Greece

Ibuprofen BRUFEN 200 mg Coated tablet Oral use

Greece Abbott Laboratories Ellas ABEE Agiou Dimitriou 63 174 56 Alimos Greece

Ibuprofen BRUFEN 600 mg Film-coated tablet Oral use

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INN Invented name Strength Pharmaceutical form

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Greece Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen IBUPROFEN/ACTAVIS 200 mg Film-coated tablet Oral use

Greece Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen IBUPROFEN/ACTAVIS 600 mg Film-coated tablet Oral use

Greece Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen IBUPROFEN/ACTAVIS 800 mg Film-coated tablet Oral use

Greece Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen IBUPROFEN/ACTAVIS 400 mg Film-coated tablet Oral use

Greece Boehringer Ingelheim International GmbH P.O.BOX 200 D-6507 Ingelheim am Rhein Germany

Ibuprofen pseudoephedrine hydrochloride

MUCOCOLD 200 mg 30 mg

Film-coated tablet Oral use

Greece Pfizer Ellas Α.Ε. Mesogeion 243, 154 51, Neo Psihiko Greece

Ibuprofen ADVIL 400 mg Film-coated tablet Oral use

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INN Invented name Strength Pharmaceutical form

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Greece Pfizer Ellas Α.Ε. Mesogeion 243, 154 51, Neo Psihiko Greece

Ibuprofen ADVIL 200 mg Capsule, soft Oral use

Greece Pfizer Ellas Α.Ε. Mesogeion 243, 154 51, Neo Psihiko Greece

Ibuprofen ADVIL 200 mg Coated tablet Oral use

Greece Pfizer Ellas Α.Ε. Mesogeion 243, 154 51, Neo Psihiko Greece

Ibuprofen ADVIL 400 mg Capsule, soft Oral use

Greece IOUL & EIR TSETI FAR/KA ERGASTIRIA ABEE D.T. "INTERMED ABEE" Kalyftaki 27, 145 64, Kifisia Greece

Ibuprofen ALGOFREN 400 mg Effervescent granules Oral use

Greece IOUL & EIR TSETI FAR/KA ERGASTIRIA ABEE D.T. "INTERMED ABEE" Kalyftaki 27, 145 64, Kifisia Greece

Ibuprofen ALGOFREN 600 mg Effervescent granules Oral use

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INN Invented name Strength Pharmaceutical form

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Greece IOUL & EIR TSETI FAR/KA ERGASTIRIA ABEE D.T. "INTERMED ABEE" Kalyftaki 27, 145 64, Kifisia Greece

Ibuprofen ALGOFREN 600 mg Film-coated tablet Oral use

Greece IOUL & EIR TSETI FAR/KA ERGASTIRIA ABEE D.T. "INTERMED ABEE" Kalyftaki 27, 145 64, Kifisia Greece

Ibuprofen ALGOFREN 500 mg Suppository Rectal use

Greece IOUL & EIR TSETI FAR/KA ERGASTIRIA ABEE D.T. "INTERMED ABEE" Kalyftaki 27, 145 64, Kifisia Greece

Ibuprofen ALGOFREN 400 mg Effervescent tablet Oral use

Greece IOUL & EIR TSETI FAR/KA ERGASTIRIA ABEE D.T. "INTERMED ABEE" Kalyftaki 27, 145 64, Kifisia Greece

Ibuprofen ALGOFREN 200 mg Effervescent granules Oral use

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INN Invented name Strength Pharmaceutical form

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Greece IOUL & EIR TSETI FAR/KA ERGASTIRIA ABEE D.T. "INTERMED ABEE" Kalyftaki 27, 145 64, Kifisia Greece

Ibuprofen ALGOFREN 200 mg Effervescent tablet Oral use

Greece IOUL & EIR TSETI FAR/KA ERGASTIRIA ABEE D.T. "INTERMED ABEE" Kalyftaki 27, 145 64, Kifisia Greece

Ibuprofen ALGOFREN 200 mg Film-coated tablet Oral use

Greece Reckitt Benckiser Hellas Chemical ABEE Taki Kavalieratou 7 Street 14564 Kato Kifissia Athens Greece

Ibuprofen NUROFEN (MINT) 200 mg Orodispersible tablet Oral use

Greece Reckitt Benckiser Hellas Chemical ABEE Taki Kavalieratou 7 Street 14564 Kato Kifissia Athens Greece

Ibuprofen pseudoephedrine hydrochloride

NUROFEN COLD AND FLU

200 mg 30 mg

Film-coated tablet Oral use

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INN Invented name Strength Pharmaceutical form

Route of administration

Greece Reckitt Benckiser Hellas Chemical ABEE Taki Kavalieratou 7 Street 14564 Kato Kifissia Athens Greece

Ibuprofen NUROFEN (LEMON) 200 mg Orodispersible tablet Oral use

Greece Reckitt Benckiser Hellas Chemical ABEE Taki Kavalieratou 7 Street 14564 Kato Kifissia Athens Greece

Ibuprofen NUROFEN 400 mg Capsule, soft Oral use

Greece Reckitt Benckiser Hellas Chemical ABEE Taki Kavalieratou 7 Street 14564 Kato Kifissia Athens Greece

Ibuprofen NUROFEN LIQUID CAPSULES

200 mg Capsule, soft Oral use

Greece Reckitt Benckiser Hellas Chemical ABEE Taki Kavalieratou 7 Street 14564 Kato Kifissia Athens Greece

Ibuprofen NUROFEN 200 mg Coated tablet Oral use

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INN Invented name Strength Pharmaceutical form

Route of administration

Greece Reckitt Benckiser Hellas Chemical ABEE Taki Kavalieratou 7 Street 14564 Kato Kifissia Athens Greece

Ibuprofen NUROFEN 200 mg Capsule, soft Oral use

Greece Reckitt Benckiser Hellas Chemical ABEE Taki Kavalieratou 7 Street 14564 Kato Kifissia Athens Greece

Ibuprofen sodium dihydrate

NUROFEN EXPRESS 256 mg Coated tablet Oral use

Greece Reckitt Benckiser Hellas Chemical ABEE Taki Kavalieratou 7 Street 14564 Kato Kifissia Athens Greece

Ibuprofen sodium dihydrate

NUROFEN EXPRESS 512 mg Coated tablet Oral use

Greece GALENICA A.E. Eleftherias 4, 14564, Kifissia, Greece

Dexibuprofen SERACTIL 300 mg Film-coated tablet Oral use

Greece GALENICA A.E. Eleftherias 4, 14564, Kifissia, Greece

Dexibuprofen SERACTIL 400 mg Film-coated tablet Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Greece Pfizer Ellas Α.Ε. Mesogeion 243, 154 51, Neo Psihiko Greece

Ibuprofen ADVIL 100mg/5ml Oral suspension Oral use

Greece IOUL & EIR TSETI FAR/KA ERGASTIRIA ABEE D.T. "INTERMED ABEE" Kalyftaki 27, 145 64, Kifisia Greece

Ibuprofen ALGOFREN 400 mg Film-coated tablet Oral use

Greece IOUL & EIR TSETI FAR/KA ERGASTIRIA ABEE D.T. "INTERMED ABEE" Kalyftaki 27, 145 64, Kifisia Greece

Ibuprofen ALGOFREN 100mg/5ml Syrup Oral use

Hungary Pfizer Corporation Austria GmbH Floridsdorfer Hauptstraße 1 1210 Wien Austria

Ibuprofen ADVIL ULTRA FORTE lágy kapszula

400 mg Capsule, soft Oral use

Hungary Pfizer Corporation Austria GmbH Floridsdorfer Hauptstraße 1 1210 Wien Austria

Ibuprofen ADVIL ULTRA lágy kapszula

200 mg Capsule, soft Oral use

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INN Invented name Strength Pharmaceutical form

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Hungary sanofi-aventis Zrt. 1045 Budapest, Tó u. 1-5. Hungary

Ibuprofen ALGOFLEX 200 mg filmtabletta

200 mg Film-coated tablet Oral use

Hungary sanofi-aventis Zrt. 1045 Budapest, Tó u. 1-5. Hungary

Ibuprofen ALGOFLEX 400 mg filmtabletta

400 mg Film-coated tablet Oral use

Hungary sanofi-aventis Zrt. 1045 Budapest, Tó u. 1-5. Hungary

Ibuprofen ALGOFLEX FORTE filmtabletta

600 mg Film-coated tablet Oral use

Hungary sanofi-aventis Zrt. 1045 Budapest, Tó u. 1-5. Hungary

Ibuprofen ALGOFLEX Izom+Ízület 300 mg retard kemény kapszula

300 mg Prolonged-release capsule, hard

Oral use

Hungary sanofi-aventis Zrt. 1045 Budapest, Tó u. 1-5. Hungary

Ibuprofen ALGOFLEX NORMA 400 mg filmtabletta

400 mg Film-coated tablet Oral use

Hungary sanofi-aventis Zrt. 1045 Budapest, Tó u. 1-5. Hungary

Ibuprofen ALGOFLEX RAPID 400 mg filmtabletta

400 mg Film-coated tablet Oral use

Hungary sanofi-aventis Zrt. 1045 Budapest, Tó u. 1-5. Hungary

Ibuprofen drotaverine

ALGOFLEX-M tabletta 400 mg Tablet oral use

Hungary Abbott Laboratories Magyarország Kft. 1095 Budapest Lechner Ödön fasor 7 Hungary

Ibuprofen Brufen 400 mg pezsgőgranulátum

400 mg Effervescent granules Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Hungary Abbott Laboratories Magyarország Kft. 1095 Budapest Lechner Ödön fasor 7 Hungary

Ibuprofen BRUFEN 800 mg retard tabletta

800 mg Prolonged-release tablet

Oral use

Hungary Abbott Laboratories Magyarország Kft. 1095 Budapest Lechner Ödön fasor 7 Hungary

Ibuprofen BRUFEN cukormentes 40 mg/ml belsőleges szuszpenzió

40 mg/ml Oral suspension Oral use

Hungary Dolorgiet GmbH & Co. KG Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany

Ibuprofen DOLGIT AKUT 400 mg lágy kapszula

400 mg Capsule, soft Oral use

Hungary Dolorgiet GmbH & Co. KG Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany

Ibuprofen DOLGIT MAX 800 mg filmtabletta

800 mg Film-coated tablet Oral use

Hungary Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibuprofen IBUMAX 200 mg filmtabletta

200 mg Film-coated tablet Oral use

Hungary Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibuprofen IBUMAX 400 mg filmtabletta

400 mg Film-coated tablet Oral use

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INN Invented name Strength Pharmaceutical form

Route of administration

Hungary Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibuprofen IBUMAX 600 mg filmtabletta

600 mg Film-coated tablet Oral use

Hungary Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibuprofen IBUMAX 800 mg filmtabletta

800 mg Film-coated tablet Oral use

Hungary APC Instytut Sp. z o.o. Grójecka st. 22/24 lok. 4 02-301 Warsaw Poland

Ibuprofen IBUPROFEN APC 200 mg filmtabletta

200 mg Film-coated tablet Oral use

Hungary APC Instytut Sp. z o.o. Grójecka st. 22/24 lok. 4 02-301 Warsaw Poland

Ibuprofen IBUPROFEN APC 400 mg filmtabletta

400 mg Film-coated tablet Oral use

Hungary Boehringer Ingelheim International GmbH Binger Straße 173 55216 Ingelheim am Rhein Germany

Ibuprofen IBUPROFEN BOEHRINGER INGELHEIM 400 mg lágy kapszula

400 mg Capsule, soft Oral use

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INN Invented name Strength Pharmaceutical form

Route of administration

Hungary Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

Ibuprofen IBUPROFEN GALPHARM 200 mg filmtabletta

200 mg Film-coated tablet Oral use

Hungary Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

Ibuprofen IBUPROFEN GALPHARM 400 mg filmtabletta

400 mg Film-coated tablet Oral use

Hungary Pharmaceutical Works Polfa in Pabianice Joint-Stock Co. Marszałka J. Piłsudskiego St. 5 95-200 Pabianice Poland

Ibuprofen IBUPROFEN POLFA 200 mg bevont tabletta

200 mg Coated tablet Oral use

Hungary Rockspring Healthcare Limited 38/40 Chamberlayne Road London NW10 3JE United Kingdom

Ibuprofen IBUPROFEN ROCKSPRING 600 mg pezsgőgranulátum

600 mg Effervescent granules Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Hungary ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen IBUPROFEN-RATIOPHARM 200 mg filmtabletta

200 mg Film-coated tablet Oral use

Hungary ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen IBUPROFEN-RATIOPHARM 400 mg filmtabletta

400 mg Film-coated tablet Oral use

Hungary Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany

Ibuprofen IBUSTAR 400 mg filmtabletta

400 mg Film-coated tablet Oral use

Hungary PANNONPHARMA Gyógyszergyártó Kft. 7720 Pécsvárad Pannonpharma út 1. Hungary

Ibuprofen MELFEN 200 mg bevont tabletta

200 mg Coated tablet Oral use

Hungary PANNONPHARMA Gyógyszergyártó Kft. 7720 Pécsvárad Pannonpharma út 1. Hungary

Ibuprofen MELFEN 400 mg bevont tabletta

400 mg Coated tablet Oral use

Hungary Boehringer Ingelheim International GmbH Binger Straße 173 55216 Ingelheim am Rhein Germany

Ibuprofen pseudoephedrine

MUCOGRIP 200 mg/30 mg filmtabletta

200 mg 30 mg

Film-coated tablet Oral use

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INN Invented name Strength Pharmaceutical form

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Hungary Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Ibuprofen NUROFEN 200 mg bevont tabletta

200 mg Coated tablet Oral use

Hungary Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Ibuprofen pseudoephedrine

NUROFEN COLD and FLU 200 mg/30 mg filmtabletta

200 mg 30 mg

Film-coated tablet Oral use

Hungary Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Ibuprofen NUROFEN eperízű 20 mg/ml belsőleges szuszpenzió gyermekeknek

20 mg/ml Oral suspension Oral use

Hungary Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Ibuprofen NUROFEN FORTE 400 mg bevont tabletta

400 mg Coated tablet Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Hungary Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Ibuprofen NUROFEN NON-AQUA 200 mg szájban diszpergálódó tabletta

200 mg Orodispersible tablet Oral use

Hungary Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Ibuprofen NUROFEN RAPID 200 mg lágy kapszula

200 mg Capsule, soft Oral use

Hungary Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Ibuprofen NUROFEN RAPID bevont tabletta

200 mg Coated tablet Oral use

Hungary Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Ibuprofen NUROFEN RAPID FORTE 400 mg lágy kapszula

400 mg Capsule, soft Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

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Hungary Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Ibuprofen NUROFEN RAPID FORTE 400 mg por belsőleges oldathoz

400 mg Powder for oral solution

Oral use

Hungary Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Ibuprofen NUROFEN RAPID FORTE bevont tabletta

400 mg Coated tablet Oral use

Hungary TEVA Gyógyszergyár zRt. 4042 Debrecen Pallagi út 13. Hungary

Ibuprofen RAPIDOPHEN 200 mg granulátum belsőleges oldathoz

200 mg Granules for oral solution

Oral use

Hungary TEVA Gyógyszergyár zRt. 4042 Debrecen Pallagi út 13. Hungary

Ibuprofen RAPIDOPHEN 200 mg lágy kapszula

200 mg Capsule, soft Oral use

Hungary TEVA Gyógyszergyár zRt. 4042 Debrecen Pallagi út 13. Hungary

Ibuprofen RAPIDOPHEN 400 mg granulátum belsőleges oldathoz

400 mg Granules for oral solution

Oral use

Hungary TEVA Gyógyszergyár zRt. 4042 Debrecen Pallagi út 13. Hungary

Ibuprofen RAPIDOPHEN 400 mg lágy kapszula

400 mg Capsule, soft Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Hungary TEVA Gyógyszergyár zRt. 4042 Debrecen Pallagi út 13. Hungary

Ibuprofen RAPIDOPHEN 600 mg granulátum belsőleges oldathoz

600 mg Granules for oral solution

Oral use

Hungary TEVA Gyógyszergyár zRt. 4042 Debrecen Pallagi út 13. Hungary

Ibuprofen RAPIDOPHEN BABY 20 mg/ml belsőleges szuszpenzió

20 mg/ml Oral suspension Oral use

Hungary sanofi-aventis Zrt. 1045 Budapest, Tó u. 1-5. Hungary

Ibuprofen pseudoephedrine

RHINATHIOL COLD 200 mg/30 mg filmtabletta

200 mg 30 mg

film-coated tablet oral use

Hungary Zambon S.p.A. Via Lillo del Duca 10 20091, Bresso (Mi) Italy

Ibuprofen SPEDIFEN 400 mg filmtabletta

400 mg Film-coated tablet Oral use

Hungary Zambon S.p.A. Via Lillo del Duca 10 20091, Bresso (Mi) Italy

Ibuprofen SPEDIFEN 400 mg granulátum

400 mg Granules Oral use

Hungary Zambon S.p.A. Via Lillo del Duca 10 20091, Bresso (Mi) Italy

Ibuprofen SPEDIFEN 600 mg granulátum

600 mg Granules Oral use

Hungary Gebro Pharma GmbH 13 Bahnhofbichl 6391 Fieberbrunn Austria

Dexibuprofen Seractil 400 mg filmtabletta

400 mg Film-coated tablet Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

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Hungary Gebro Pharma GmbH 13 Bahnhofbichl 6391 Fieberbrunn Austria

Dexibuprofen Seractil Dolo 200 mg filmtabletta

200 mg Film-coated tablet Oral use

Hungary Gebro Pharma GmbH 13 Bahnhofbichl 6391 Fieberbrunn Austria

Dexibuprofen Seractil Dolo 300 mg filmtabletta

300 mg Film-coated tablet Oral use

Iceland Alvogen IPCo S.àr.l. Rue Heienhaff, 5 L-1736, Senningerberg Luxemburg

Ibuprofen Alvofen Express 200 mg Capsule, soft Oral use

Iceland Alvogen IPCo S.àr.l. Rue Heienhaff, 5 L-1736, Senningerberg Luxemburg

Ibuprofen Alvofen Express 400 mg Capsule, soft Oral use

Iceland Bristol Laboratories Limited, Unit 3, Canalside Northbridge Road, Berkhamstead, Hertfordshire HP4 1EG United Kingdom

Ibuprofen Ibuprofen Bril 200 mg Film-coated tablet Oral use

Iceland Bristol Laboratories Limited, Unit 3, Canalside Northbridge Road, Berkhamstead, Hertfordshire HP4 1EG United Kingdom

Ibuprofen Ibuprofen Bril 400 mg Film-coated tablet Oral use

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INN Invented name Strength Pharmaceutical form

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Iceland Bristol Laboratories Limited, Unit 3, Canalside Northbridge Road, Berkhamstead, Hertfordshire HP4 1EG United Kingdom

Ibuprofen Ibuprofen Bril 600 mg Film-coated tablet Oral use

Iceland ratiopharm Oy Keilaranta 10 02150 Espoo Finland

Ibuprofen Ibuxin 200 mg Film-coated tablet Oral use

Iceland ratiopharm Oy Keilaranta 10 02150 Espoo Finland

Ibuprofen Ibuxin 400 mg Film-coated tablet Oral use

Iceland ratiopharm Oy Keilaranta 10 02150 Espoo Finland

Ibuprofen Ibuxin 600 mg Film-coated tablet Oral use

Iceland ratiopharm Oy Keilaranta 10 02150 Espoo Finland

Ibuprofen Ibuxin 800 mg Film-coated tablet Oral use

Iceland ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen ibuxin rapid 400 mg Film-coated tablet Oral use

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INN Invented name Strength Pharmaceutical form

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Iceland Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Íbúfen 200 mg Film-coated tablet Oral use

Iceland Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Íbúfen 400 mg Film-coated tablet Oral use

Iceland Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Íbúfen 600 mg Film-coated tablet Oral use

Iceland Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Íbúfen 800 mg Film-coated tablet Oral use

Iceland Portfarma ehf. Borgartúni 26 105 Reykjavík Iceland

Ibuprofen Íbúprófen Portfarma 400 mg Film-coated tablet Oral use

Ireland GlaxoSmithKline Consumer Healthcare (Ireland) Limited Stonemasons Way Rathfarnham Dublin 16 Ireland

Ibuprofen Actiprofen 200mg Tablets

200 mg Film-coated tablet Oral use

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INN Invented name Strength Pharmaceutical form

Route of administration

Ireland Pfizer Healthcare Ireland 9 Riverwalk National Digital Park Citywest Business Campus Dublin 24 Ireland

Ibuprofen Advil 200mg Tablets 200 mg Coated tablet Oral use

Ireland Pfizer Healthcare Ireland 9 Riverwalk National Digital Park Citywest Business Campus Dublin 24 Ireland

Ibuprofen pseudoephedrine hydrochloride

Advil Cold and Flu Coated Tablets

200 mg 30 mg

Coated tablet Oral use

Ireland Pfizer Healthcare Ireland 9 Riverwalk National Digital Park Citywest Business Campus Dublin 24 Ireland

Ibuprofen Advil Liquigels, 200mg Capsules

200 mg Capsule, soft Oral use

Ireland GlaxoSmithKline Consumer Healthcare (Ireland) Limited Stonemasons Way Rathfarnham Dublin 16 Ireland

Ibuprofen codeine phosphate hemihydrate

Apfen Plus 200mg / 12.8mg Film-Coated Tablets

200 mg 12.8 mg

Film-coated tablet Oral use

145

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Ireland BGP Products Ireland Limited Kingswood Drive 4051 Citywest Business Campus Dublin 24 Ireland

Ibuprofen Brufen 400mg film-coated tablets

400 mg Film-coated tablet Oral use

Ireland BGP Products Ireland Limited Kingswood Drive 4051 Citywest Business Campus Dublin 24 Ireland

Ibuprofen Brufen 600mg film-coated tablets

600 mg Film-coated tablet Oral use

Ireland BGP Products Ireland Limited Kingswood Drive 4051 Citywest Business Campus Dublin 24 Ireland

Ibuprofen Brufen 400mg Effervescent Granules

400 mg Effervescent granules Oral use

Ireland BGP Products Ireland Limited Kingswood Drive 4051 Citywest Business Campus Dublin 24 Ireland

Ibuprofen Brufen Paediatric 100 mg / 5 ml Oral Suspension.

20 mg/ml Oral suspension Oral use

146

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Ireland BGP Products Ireland Limited Kingswood Drive 4051 Citywest Business Campus Dublin 24 Ireland

Ibuprofen Brufen Retard 800mg Prolonged Release Tablets

800 mg Prolonged-release tablet

Oral use

Ireland Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Buplex 200mg film-coated tablets

200 mg Film-coated tablet Oral use

Ireland Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Buplex 400mg film-coated tablets

400 mg Film-coated tablet Oral use

Ireland Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Buplex Rx 200 mg film-coated tablets

200 mg Film-coated tablet Oral use

Ireland Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Buplex Rx 400 mg film-coated tablets

400 mg Film-coated tablet Oral use

Ireland Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Buplex Rx 600 mg film-coated tablets

600 mg Film-coated tablet Oral use

147

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Ireland Clonmel Healthcare Ltd. Waterford Road, Co. Tipperary Ireland

Ibuprofen Easofen 200mg Film-Coated Tablets.

200 mg Film-coated tablet Oral use

Ireland Clonmel Healthcare Ltd. Waterford Road, Co. Tipperary Ireland

Ibuprofen Easofen Max Strength 400 mg Film-coated Tablets

400 mg Film-coated tablet Oral use

Ireland Pinewood Laboratories Limited Ballymacarbry, Clonmel Co Tipperary Ireland

Ibuprofen Fenopine 200 mg Film-coated Tablets.

200 mg Film-coated tablet Oral use

Ireland Pinewood Laboratories Limited Ballymacarbry, Clonmel Co Tipperary Ireland

Ibuprofen Fenopine 400 mg Film-coated Tablets.

400 mg Film-coated tablet Oral use

Ireland Pinewood Laboratories Limited Ballymacarbry, Clonmel Co Tipperary Ireland

Ibuprofen Fenopine 600 mg Film-Coated Tablets.

600 mg Film-coated tablet Oral use

148

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Ireland BGP Products Ireland Limited Kingswood Drive 4051 Citywest Business Campus Dublin 24 Ireland

Ibuprofen Brufen 200mg Effervescent Granules

200 mg Effervescent granules Oral use

Ireland McDermott Laboratories Ltd t/a Gerard Laboratories 35/36 Baldoyle Industrial Estate Grange Road Dublin 13 Ireland

Ibuprofen Ibuprofen 200mg film-coated tablets

200 mg Film-coated tablet Oral use

Ireland McDermott Laboratories Ltd t/a Gerard Laboratories 35/36 Baldoyle Industrial Estate Grange Road Dublin 13 Ireland

Ibuprofen Ibuprofen 400mg film-coated tablets

400 mg Film-coated tablet Oral use

Ireland BGP Products Ireland Limited Kingswood Drive 4051 Citywest Business Campus Dublin 24 Ireland

Ibuprofen Brufen 600mg Effervescent Granules

600 mg Effervescent granules Oral use

149

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Ireland The Boots Company PLC 1 Thane Road West Nottingham NG2 3AA United Kingdom

Ibuprofen codeine phosphate hemihydrate

Ibuprofen and Codeine 200 mg/ 12.8 mg film-coated Tablets

200 mg 12.8 mg

Film-coated tablet Oral use

Ireland Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

Ibuprofen Ibuprofen Galpharm 200mg Film-coated Tablets

200 mg Film-coated tablet Oral use

Ireland Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

Ibuprofen Ibuprofen Galpharm Max 400mg Film-coated Tablets

400 mg Film-coated tablet Oral use

Ireland Clonmel Healthcare Ltd. Waterford Road, Co. Tipperary Ireland

Ibuprofen Melfen 200mg Film-coated tablets

200 mg Film-coated tablet Oral use

150

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Ireland Clonmel Healthcare Ltd. Waterford Road, Co. Tipperary Ireland

Ibuprofen Melfen 400mg Film-coated tablets

400 mg Film-coated tablet Oral use

Ireland Reckitt Benckiser Ireland Ltd. 7 Riverwalk Citywest Business Campus Dublin 24 Ireland

Ibuprofen Nurofen 200 mg Coated Tablets

200 mg Coated Tablet Oral use

Ireland Reckitt Benckiser Ireland Ltd. 7 Riverwalk Citywest Business Campus Dublin 24 Ireland

Ibuprofen Nurofen 200mg Effervescent Tablets

200 mg Effervescent tablet Oral use

Ireland Crookes Healthcare Ltd., Thane Road West 1 Nottingham NG2 3AA United Kingdom

Ibuprofen Nurofen Advance 200 mg Tablets.

200 mg Film-coated tablet Oral use

Ireland Reckitt Benckiser Ireland Ltd. 7 Riverwalk Citywest Business Campus Dublin 24 Ireland

Ibuprofen Nurofen Advance Maximum Strength 400mg oral powder

400 mg Powder for oral solution

Oral use

151

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Ireland Reckitt Benckiser Ireland Ltd. 7 Riverwalk Citywest Business Campus Dublin 24 Ireland

Ibuprofen pseudoephedrine hydrochloride

Nurofen Cold & Flu Film-coated Tablets

200 mg 30 mg

Film-coated tablet Oral use

Ireland Reckitt Benckiser Ireland Ltd. 7 Riverwalk Citywest Business Campus Dublin 24 Ireland

Ibuprofen Nurofen Express 200 mg Tablets

200 mg Coated tablet Oral use

Ireland Reckitt Benckiser Ireland Ltd. 7 Riverwalk Citywest Business Campus Dublin 24 Ireland

Ibuprofen Nurofen Express Maximum Strength 400 mg Tablets

400 mg Coated tablet Oral use

Ireland Reckitt Benckiser Ireland Ltd. 7 Riverwalk Citywest Business Campus Dublin 24 Ireland

Ibuprofen Nurofen 200mg Liquid Capsules

200 mg Capsule, soft Oral use

152

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Ireland Reckitt Benckiser Ireland Ltd. 7 Riverwalk Citywest Business Campus Dublin 24 Ireland

Ibuprofen Nurofen 400mg Liquid Capsules

400 mg Capsule, soft Oral use

Ireland Reckitt Benckiser Ireland Ltd. 7 Riverwalk Citywest Business Campus Dublin 24 Ireland

Ibuprofen Nurofen Long Lasting 300 mg Prolonged Release Hard Capsules

300 mg Prolonged-release capsule, hard

Oral use

Ireland Reckitt Benckiser Ireland Ltd. 7 Riverwalk Citywest Business Campus Dublin 24 Ireland

Ibuprofen codeine phosphate hemihydrate

Nurofen Plus Tablets 200 mg 12.8 mg

Film-coated tablet Oral use

Ireland Pfizer Healthcare Ireland 9 Riverwalk National Digital Park Citywest Business Campus Dublin 24 Ireland

Ibuprofen Seclodin 400mg Tablets 400 mg Tablet Oral use

153

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Ireland Pfizer Healthcare Ireland 9 Riverwalk National Digital Park Citywest Business Campus Dublin 24 Ireland

Ibuprofen Seclodin 400mg Soft Capsules

400 mg Capsule, soft Oral use

Italy BGP PRODUCTS S.R.L. VIALE GIORGIO RIBOTTA 11 00144 ROMA Italy

Ibuprofen BRUFEN 600 mg Effervescent granules Oral use

Italy BGP PRODUCTS S.R.L. VIALE GIORGIO RIBOTTA 11 00144 ROMA Italy

Ibuprofen BRUFEN 800 mg Film-coated prolonged-release tablet

Oral use

Italy BGP PRODUCTS S.R.L. VIALE GIORGIO RIBOTTA 11 00144 ROMA Italy

Ibuprofen BRUFEN 400 mg Film-coated tablet Oral use

Italy BGP PRODUCTS S.R.L. VIALE GIORGIO RIBOTTA 11 00144 ROMA Italy

Ibuprofen BRUFEN 600 mg Film-coated tablet Oral use

154

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Italy LABORATORIO FARMACEUTICO SIT SPECIALITA' IGIENICO TERAPEUTICHE S.R.L., Via Cavour 70 27035 Mede - Pavia Italy

Ibuprofen ALGOFEN 200 mg Film-coated tablet Oral use

Italy Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Ibuprofen NUROFEN 200 mg Film-coated tablet Oral use

Italy Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Ibuprofen NUROFEN 400 mg Film-coated tablet Oral use

Italy SANDOZ S.P.A. Largo U. Boccioni 1 21040 Origgio (VA) - Italy

Ibuprofen IBUPROFENE SANDOZ 200 mg Film-coated tablet Oral use

155

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Italy Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. Viale Amelia 70 00181 Rome Italy

Ibuprofen MOMENT 200 mg Film-coated tablet Oral use

Italy Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. Viale Amelia 70 00181 Rome Italy

Ibuprofen MOMENT 200 mg/ml Oral drops, solution Oral use

Italy Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. Viale Amelia 70 00181 Rome Italy

Ibuprofen MOMENT 200 mg Granules for oral solution

Oral use

Italy Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. Viale Amelia 70 00181 Rome Italy

Ibuprofen MOMENT 200 mg Effervescent tablet Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Italy Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. Viale Amelia 70 00181 Rome Italy

Ibuprofen MOMENT 200 mg Chewable tablet Oral use

Italy Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. Viale Amelia 70 00181 Rome Italy

Ibuprofen MOMENT 200 mg Capsule, soft Oral use

Italy JOHNSON & JOHNSON S.P.A., Via Ardeatina Km 23,500 00040 Santa Palomba - Pomezia (RM) - Italy

Ibuprofen ANTALGIL 200 mg Tablet Oral use

Italy SPA ITALIANA LABORATORI BOUTY Via Vanvitelli, 4 20129 Milano Italy

Ibuprofen CALMINE 200 mg Film-coated tablet Oral use

Italy Zambon Italia S.R.L. Via Lillo del Duca 10 20091, Bresso (Mi) Italy

Ibuprofen SPIDIDOL ANALGESICO 200 mg Effervescent tablet Oral use

157

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Italy Zambon Italia S.R.L. Via Lillo del Duca 10 20091, Bresso (Mi) Italy

Ibuprofen SPIDIDOL ANALGESICO 200 mg Granules for oral solution

Oral use

Italy Zambon Italia S.R.L. Via Lillo del Duca 10 20091, Bresso (Mi) Italy

Ibuprofen SPIDIDOL ANALGESICO 200 mg/ml Oral drops, solution Oral use

Italy Zambon Italia S.R.L. Via Lillo del Duca 10 20091, Bresso (Mi) Italy

Ibuprofen SPIDIDOL ANALGESICO 200 mg tablet Oral use

Italy Zambon Italia S.R.L. Via Lillo del Duca 10 20091, Bresso (Mi) Italy

Ibuprofen SPIDIDOL 400 mg film-coated tablet Oral use

Italy Zambon Italia S.R.L. Via Lillo del Duca 10 20091, Bresso (Mi) Italy

Ibuprofen SPIDIDOL 400 mg granules for oral solution

Oral use

Italy Zambon Italia S.R.L. Via Lillo del Duca 10 20091, Bresso (Mi) Italy

Ibuprofen SPIDIFEN 400 mg film-coated tablet Oral use

Italy Zambon Italia S.R.L. Via Lillo del Duca 10 20091, Bresso (Mi) Italy

Ibuprofen SPIDIFEN 400 mg granules for oral solution

Oral use

158

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Italy Zambon Italia S.R.L. Via Lillo del Duca 10 20091, Bresso (Mi) Italy

Ibuprofen SPIDIFEN 600 mg granules for oral solution

Oral use

Italy Boehringer Ingelheim Italia S.P.A. Via Lorenzini, 8 20139 Milano Italy

Ibuprofen BUSCOFEN 200 mg Film-coated tablet Oral use

Italy Boehringer Ingelheim Italia S.P.A. Via Lorenzini, 8 20139 Milano Italy

Ibuprofen BUSCOFEN 200 mg Capsule, soft Oral use

Italy Boehringer Ingelheim Italia S.P.A. Via Lorenzini, 8 20139 Milano Italy

Ibuprofen BUSCOFEN 200 mg Granules for oral solution

Oral use

Italy Novartis Consumer Health S.P.A., Largo Umberto Boccioni 1 21040 Origgio (VA) Italy

Ibuprofen CIBALGINA DUE FAST 200 mg Gastro-resistant tablet Oral use

Italy Bracco S.P.A. Via Egidio Folli 50 20134 Milano Italy

Ibuprofen DOLOFAST 200 mg Tablet Oral use

159

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Italy Bracco S.P.A. Via Egidio Folli 50 20134 Milano Italy

Ibuprofen DOLOFAST 200 mg/ml Oral drops, solution Oral use

Italy Angenerico S.P.A. Via Nocera Umbra 75 Roma Italy

Ibuprofen IBUPROFENE ANGENERICO

200 mg Film-coated tablet Oral use

Italy Angenerico S.P.A. Via Nocera Umbra 75 Roma Italy

Ibuprofen IBUPROFENE ANGENERICO

200 mg/ml Oral drops, solution Oral use

Italy FARMAKOPEA S.P.A. Via Cavriana 14 Milano Italy

Ibuprofen SUBITENE 200 mg Effervescent tablet Oral use

Italy FARMAKOPEA S.P.A. Via Cavriana 14 Milano Italy

Ibuprofen SUBITENE 200 mg Granules for oral solution

Oral use

Italy FARMAKOPEA S.P.A. Via Cavriana 14 Milano Italy

Ibuprofen SUBITENE 400 mg Granules for oral solution

Oral use

Italy FARMAKOPEA S.P.A. Via Cavriana 14 Milano Italy

Ibuprofen SUBITENE 200 mg Film-coated tablet Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Italy Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. Viale Amelia 70 00181 Rome Italy

Ibuprofen MOMENTACT 400 mg Film-coated tablet Oral use

Italy Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. Viale Amelia 70 00181 Rome Italy

Ibuprofen MOMENTACT 400 mg Capsule, soft Oral use

Italy Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. Viale Amelia 70 00181 Rome Italy

Ibuprofen MOMENTACT ANALGESICO

400 mg Granules for oral solution

Oral use

Italy Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Ibuprofen NUROSOLV 200 mg Orodispersible tablet Oral use

Italy LABORATORI ALTER S.R.L. Via Egadi 7 20144 Milano Italy

Ibuprofen IBUPROFENE ALTER 400 mg Film-coated tablet Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Italy LABORATORI ALTER S.R.L. Via Egadi 7 20144 Milano Italy

Ibuprofen IBUPROFENE ALTER 600 mg Film-coated tablet Oral use

Italy Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Ibuprofen NUROFENELLE 200 mg Film-coated tablet Oral use

Italy Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Ibuprofen NUROFENELLE 400 mg Film-coated tablet Oral use

Italy ABC Farmaceutici S.P.A. Corso Vittorio Emanuele II 72 10121 Torino Italy

Ibuprofen KENDO 200 mg/ml Oral drops, solution Oral use

Italy RATIOPHARM ITALIA S.R.L. Viale Monza 270 20128 Milano Italy

Ibuprofen IBUPROFENE RATIOPHARM ITALIA

400 mg Film-coated tablet Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Italy ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen IBUPROFENE RATIOPHARM

200 mg Film-coated tablet Oral use

Italy Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. Viale Amelia 70 00181 Rome Italy

Ibuprofen MOMENFLOGO 600 mg Granules for oral solution

Oral use

Italy Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen ZORENDOL 200 mg Film-coated tablet Oral use

Italy Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen ZORENDOL 400 mg Film-coated tablet Oral use

Italy Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen IBUPROFENE ACTAVIS 600 mg Film-coated tablet Oral use

Italy E-PHARMA TRENTO S.P.A. Via Provina, 2 38123 Frazione Ravina - Trento Italy

Ibuprofen IBUPROFENE E-PHARMA TRENTO

400 mg Granules for oral solution

Oral use

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Italy Boots Pharmaceuticals S.R.L. Via Cesarea 11/10 16121 Genova Italy

Ibuprofen DOLIPRO 200 mg Film-coated tablet Oral use

Italy Boots Pharmaceuticals S.R.L. Via Cesarea 11/10 16121 Genova Italy

Ibuprofen DOLIPRO 400 mg Film-coated tablet Oral use

Italy Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. Viale Amelia 70 00181 Rome Italy

Ibuprofen IBUPROFENE ANGELINI 600 mg Granules for oral solution

Oral use

Italy LABORATORI ALTER S.R.L. Via Egadi 7 20144 Milano Italy

Ibuprofen SAKITOL 400 mg Film-coated tablet Oral use

Italy DOC GENERICI SRL Via Turati, 40 20121 Milano Italy

Ibuprofen IBUPROFENE DOC GENERICI

600 mg Effervescent granules Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Italy Boehringer Ingelheim International GmbH Binger Straße 173 55216 Ingelheim am Rhein Germany

Ibuprofen BUSCOFENACT 400 mg Capsule, soft Oral use

Italy Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Ibuprofen NUROFENCAPS 400 mg Capsule, soft Oral use

Italy DOC GENERICI SRL Via Turati, 40 20121 Milano Italy

Ibuprofen IBUPROFEN DOC GENERICS

20 mg/ml Oral suspension Oral use

Italy POLIFARMA BENESSERE S.R.L. Via Laurentine, 289 00142 Roma Italy

Ibuprofen VIAMAL FEBBRE E DOLORE

200 mg Film-coated tablet Oral use

Italy POLIFARMA BENESSERE S.R.L. Via Laurentine, 289 00142 Roma Italy

Ibuprofen VIAMAL FEBBRE E DOLORE

400 mg Film-coated tablet Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Italy THERABEL GIENNE PHARMA S.P.A. Via Roberto Koch 1/2 20152 Milano Italy

Dexibuprofen SERACTIL 200 mg Film-coated tablet Oral use

Italy THERABEL GIENNE PHARMA S.P.A. Via Roberto Koch 1/2 20152 Milano Italy

Dexibuprofen SERACTIL 300 mg Film-coated tablet Oral use

Italy THERABEL GIENNE PHARMA S.P.A. Via Roberto Koch 1/2 20152 Milano Italy

Dexibuprofen SERACTIL 400 mg Film-coated tablet Oral use

Italy THERABEL GIENNE PHARMA S.P.A. Via Roberto Koch 1/2 20152 Milano Italy

Dexibuprofen SERACTIL 300 mg Powder for oral suspension

Oral use

Italy THERABEL GIENNE PHARMA S.P.A. Via Roberto Koch 1/2 20152 Milano Italy

Dexibuprofen SERACTIL 400 mg Powder for oral suspension

Oral use

166

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Italy Bruno Farmaceutici S.p.A. Via delle Ande, 15 00144 Roma Italy

Dexibuprofen FENEXTRA 400 mg Film-coated tablet Oral use

Italy Bruno Farmaceutici S.p.A. Via delle Ande, 15 00144 Roma Italy

Dexibuprofen FENEXTRA 300 mg Granules for oral suspension

Oral use

Italy Bruno Farmaceutici S.p.A. Via delle Ande, 15 00144 Roma Italy

Dexibuprofen FENEXTRA 400 mg Granules for oral suspension

Oral use

Italy Boehringer Ingelheim International GmbH Binger Straße 173 55216 Ingelheim am Rhein Germany

Ibuprofen pseudoephedrine

IBUPROFENE E PSEUDOEFEDRINA BOEHRINGER INGELHEIM

200 mg 30 mg

Film-coated tablet Oral use

Italy Laboratorio Italiano Biochimico Farmaceutico Lisapharma S.P.A. Via Licinio 11 22036 Erba Como Italy

Ibuprofen lysine ARFEN 500 mg Tablet Oral use

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Italy Laboratorio Italiano Biochimico Farmaceutico Lisapharma S.P.A. Via Licinio 11 22036 Erba Como Italy

Ibuprofen lysine ARFEN 400 mg/3ml Solution for injection Parenteral use

Italy Carlo Erba O.T.C. S.R.L. Via Ardeatina Km 23 500 - Frazione LOC. Santa Palomba 00040 Pomezia Italy

Ibuprofen lysine IBUPROFENE CARLO ERBA

200 mg Film-coated tablet Oral use

Italy Carlo Erba O.T.C. S.R.L. Via Ardeatina Km 23 500 - Frazione LOC. Santa Palomba 00040 Pomezia Italy

Ibuprofen lysine IBUPROFENE CARLO ERBA

400 mg Film-coated tablet Oral use

Italy Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Ibuprofen lysine NUROFENIMMEDIA 200 mg Film-coated tablet Oral use

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Latvia CIPLA (UK) LIMITED The Old Post House Heath Road, Surrey Weybridge KT13 8TS United Kingdom

Ibuprofen Ibugesic 400 mg film-coated tablets

400 mg Film-coated tablet Oral use

Latvia CIPLA (UK) LIMITED The Old Post House Heath Road, Surrey Weybridge KT13 8TS United Kingdom

Ibuprofen Ibugesic 600 mg film-coated tablets

600 mg Film-coated tablet Oral use

Latvia Lannacher Heilmittel GmbH Schlossplatz 1 A-8502 Lannach Austria

Ibuprofen Ibuprofen Lannacher 600 mg film-coated tablets

600 mg Film-coated tablet Oral use

Latvia Lannacher Heilmittel GmbH Schlossplatz 1 A-8502 Lannach Austria

Ibuprofen Ibuprofen Lannacher 400 mg film-coated tablets

400 mg Film-coated tablet Oral use

Latvia Abbott Laboratories Baltics SIA Mukusalas 101 Riga LV 1004 Latvia

Ibuprofen codeine phosphate hemihydrate

Brufen Plus 400 mg/30 mg film-coated tablets

400 mg 30 mg

Film-coated tablet Oral use

Latvia Abbott Laboratories Baltics SIA Mukusalas 101 Riga LV 1004 Latvia

Ibuprofen Brufen 200 mg effervescent granules

200 mg Effervescent granules Oral use

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INN Invented name Strength Pharmaceutical form

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Latvia Abbott Laboratories Baltics SIA Mukusalas 101 Riga LV 1004 Latvia

Ibuprofen Brufen 600 mg effervescent granules

600 mg Effervescent granules Oral use

Latvia Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

Ibuprofen Nurofen Forte Express 400 mg coated tablets

400 mg Coated tablet Oral use

Latvia Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

Ibuprofen Nurofen Express 200 mg coated tablets

200 mg Coated tablet Oral use

Latvia Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

Ibuprofen Nurofen Forte 400 mg coated tablets

400 mg Coated tablet Oral use

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INN Invented name Strength Pharmaceutical form

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Latvia Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

Ibuprofen Nurofen 200 mg film-coated tablets

200 mg Film-coated tablet Oral use

Latvia Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

Ibuprofen pseudoephedrine hydrochloride

Nurofen Antigrip 200 mg/30 mg coated tablets

200 mg 30 mg

Coated tablet Oral use

Latvia STIROLBIOFARM BALTIKUM SIA, Rasas 5 Riga Latvia

Ibuprofen Ibuprofen Stirol 300 mg capsules

300 mg Capsule, hard Oral use

Latvia AS Grindeks Krustpils 53 LV-1057 Riga Latvia

Ibuprofen Ibuprofen - Grindeks 400 mg film-coated tablets

400 mg Film-coated tablet Oral use

Latvia AS Grindeks Krustpils 53 LV-1057 Riga Latvia

Ibuprofen Ibuprofen - Grindeks 200 mg film-coated tablets

200 mg Film-coated tablet Oral use

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INN Invented name Strength Pharmaceutical form

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Latvia AS “Olainfarm” Rupnicu iela 5 Olaine LV-2114 Latvia

Ibuprofen Ibuprofen Olainfarm 400 mg film-coated tablets

400 mg Film-coated tablet Oral use

Latvia AS “Olainfarm” Rupnicu iela 5 Olaine LV-2114 Latvia

Ibuprofen Ibulain 200 mg film-coated tablets

200 mg Film-coated tablet Oral use

Latvia Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany

Ibuprofen Ibustar 400 mg film-coated tablets

400 mg Film-coated tablet Oral use

Latvia STADA Arzneimittel AG Stadastr. 2-18 61118 Bad Vilbel Germany

Ibuprofen Ibudolor 200 mg coated tablets

200 mg Coated tablet Oral use

Latvia CTO LT UAB S.Daukanto g. 4 Siauliu, Siauliu m., Siauliu m.sav., Lithuania LT-77171

Ibuprofen Ibufanti 100 mg/5 ml oral suspension

20 mg/ml Oral suspension Oral use

Latvia ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen Ibuprofen-ratiopharm 400 mg film-coated tablets

400 mg Film-coated tablet Oral use

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Latvia ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen Butifen 400 mg film-coated tablets

400 mg Film-coated tablet Oral use

Latvia Abbott Laboratories Baltics SIA Mukusalas 101 Riga LV 1004 Latvia

Ibuprofen Brufen 400 mg effervescent granules

400 mg Effervescent granules Oral use

Latvia Abbott Laboratories Baltics SIA Mukusalas 101 Riga LV 1004 Latvia

Ibuprofen Brufen 200 mg film-coated tablets

200 mg Film-coated tablet Oral use

Latvia Abbott Laboratories Baltics SIA Mukusalas 101 Riga LV 1004 Latvia

Ibuprofen Brufen 20 mg/ml oral suspension

20 mg/ml Oral suspension Oral use

Latvia Abbott Laboratories Baltics SIA Mukusalas 101 Riga LV 1004 Latvia

Ibuprofen Brufen 800 mg prolonged-release tablets

800 mg Prolonged-release tablet

Oral use

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INN Invented name Strength Pharmaceutical form

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Latvia Abbott Laboratories Baltics SIA Mukusalas 101 Riga LV 1004 Latvia

Ibuprofen Brufen 400 mg film-coated tablets

400 mg Film-coated tablet Oral use

Latvia UAB “INTELI GENERICS NORD”, Seimyniskiu g. 3 Vilnius, LT-09312 Lithuania

Ibuprofen Ibuprofen Inteli 100 mg/5 ml oral suspension

20 mg/ml Oral suspension Oral use

Latvia Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Ibuprofen Ibuprofen Zentiva 400 mg film-coated tablets

400 mg Film-coated tablet Oral use

Latvia Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Ibuprofen Ibuprofen Zentiva 200 mg film-coated tablets

200 mg Film-coated tablet Oral use

Latvia Takeda Pharma AS Jaama 55B Polva 63308 Estonia

Ibuprofen Ibumetin 200 mg film-coated tablets

200 mg Film-coated tablet Oral use

Latvia Takeda Pharma AS Jaama 55B Polva 63308 Estonia

Ibuprofen Ibumetin 400 mg film-coated tablets

400 mg Film-coated tablet Oral use

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INN Invented name Strength Pharmaceutical form

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Latvia Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Ibuprofen Ibalgin Fast 400 mg film-coated tablets

400 mg Film-coated tablet Oral use

Latvia Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibuprofen Ibumax 200 mg film-coated tablets

200 mg Film-coated tablet Oral use

Latvia Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibuprofen Ibumax 400 mg film-coated tablets

400 mg Film-coated tablet Oral use

Latvia Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibuprofen Ibumax 600 mg film-coated tablets

600 mg Film-coated tablet Oral use

Lithuania BGP Products SIA, Mukusalas 101 Riga LV 1004 Latvia

Ibuprofen Abfen 40 mg/ml Oral suspension Oral use

Lithuania BGP Products SIA, Mukusalas 101 Riga LV 1004 Latvia

Ibuprofen Brufen 200 mg Film-coated tablet Oral use

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INN Invented name Strength Pharmaceutical form

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Lithuania BGP Products SIA, Mukusalas 101 Riga LV 1004 Latvia

Ibuprofen Brufen 400 mg Film-coated tablet Oral use

Lithuania BGP Products SIA, Mukusalas 101 Riga LV 1004 Latvia

Ibuprofen Brufen 800 mg Prolonged-release tablet

Oral use

Lithuania BGP Products SIA, Mukusalas 101 Riga LV 1004 Latvia

Ibuprofen Brufen 400 mg Effervescent granules Oral use

Lithuania BGP Products SIA, Mukusalas 101 Riga LV 1004 Latvia

Ibuprofen Brufen 20 mg/ml Oral suspension Oral use

Lithuania ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen Butifen 400 mg Film-coated tablet Oral use

Lithuania STADA Arzneimittel AG Stadastr. 2-18 61118 Bad Vilbel Germany

Ibuprofen IBUDOLOR 200 mg Film-coated tablet Oral use

Lithuania Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibuprofen IBUMAX 200 mg Film-coated tablet Oral use

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INN Invented name Strength Pharmaceutical form

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Lithuania Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibuprofen IBUMAX 400 mg Film-coated tablet Oral use

Lithuania Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibuprofen IBUMAX 600 mg Film-coated tablet Oral use

Lithuania Pabianickie Zakłady Farmaceutyczne Polfa S.A. Marszalka Pilsudskiego st. 5 95-200 Pabianice Poland

Ibuprofen IBUPROFEN Polfa 200 mg Coated tablet Oral use

Lithuania AS Grindeks Krustpils 53 LV-1057 Riga Latvia

Ibuprofen IBUPROFEN-GRINDEKS 200 mg Film-coated tablet Oral use

Lithuania US Pharmacia Sp. z o.o. Ziebicka st. 40 50-507 Wroclaw Poalnd

Ibuprofen IBUPROM 200 mg Coated tablet Oral use

Lithuania US Pharmacia Sp. z o.o. Ziebicka st. 40 50-507 Wroclaw Poalnd

Ibuprofen IBUPROM 400 mg Film-coated tablet Oral use

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INN Invented name Strength Pharmaceutical form

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Lithuania Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Ibuprofen Ibalgin Fast 400 mg Film-coated tablet Oral use

Lithuania Takeda Pharma AS Jaama 55B Polva 63308 Estonia

Ibuprofen Ibumetin 200 mg Film-coated tablet Oral use

Lithuania Takeda Pharma AS Jaama 55B Polva 63308 Estonia

Ibuprofen Ibumetin 400 mg Film-coated tablet Oral use

Lithuania Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Ibuprofen Actavis 200 mg Film-coated tablet Oral use

Lithuania Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Ibuprofen Actavis 400 mg Film-coated tablet Oral use

Lithuania Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Ibuprofen Actavis 600 mg Film-coated tablet Oral use

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INN Invented name Strength Pharmaceutical form

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Lithuania Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Ibuprofen Actavis 800 mg Film-coated tablet Oral use

Lithuania Lannacher Heilmittel GmbH Schlossplatz 1 A-8502 Lannach Austria

Ibuprofen Ibuprofen Lannacher 400 mg Film-coated tablet Oral use

Lithuania Lannacher Heilmittel GmbH Schlossplatz 1 A-8502 Lannach Austria

Ibuprofen Ibuprofen Lannacher 600 mg Film-coated tablet Oral use

Lithuania BGP Products SIA, Mukusalas 101 Riga LV 1004 Latvia

Ibuprofen Brufen 200 mg Effervescent granules Oral use

Lithuania BGP Products SIA, Mukusalas 101 Riga LV 1004 Latvia

Ibuprofen Brufen 600 mg Effervescent granules Oral use

Lithuania Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Ibuprofen Ibuprofen Zentiva 200 mg Film-coated tablet Oral use

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INN Invented name Strength Pharmaceutical form

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Lithuania Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Ibuprofen Ibuprofen Zentiva 400 mg Film-coated tablet Oral use

Lithuania US Pharmacia Sp. z o.o. Ziebicka st. 40 50-507 Wroclaw Poalnd

Ibuprofen Ibuprom Express 400 mg Capsule, soft Oral use

Lithuania Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany

Ibuprofen Ibustar 400 mg Film-coated tablet Oral use

Lithuania Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Ifenin 200 mg Film-coated tablet Oral use

Lithuania Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Ifenin 400 mg Film-coated tablet Oral use

Lithuania Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

Ibuprofen NUROFEN 200 mg Coated tablet Oral use

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INN Invented name Strength Pharmaceutical form

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Lithuania Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

Ibuprofen NUROFEN EXPRESS 200 mg Coated tablet Oral use

Lithuania Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

Ibuprofen NUROFEN FORTE 400 mg Coated tablet Oral use

Lithuania Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

Ibuprofen NUROFEN FORTE EXPRESS

400 mg Coated tablet Oral use

Lithuania UAB Corpus Medica Sukilėlių pr. 61 LT-49333 Kaunas Lithuania

Ibuprofen TVINGESTIN 400 mg Film-coated tablet Oral use

Luxembourg Pfizer bv Rivium Westlaan 142 2909 LD, Capelle a/d Ijssel The Netherlands

Ibuprofen Advil Mono Liquid Caps 200 mg Effervescent tablet Oral use

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INN Invented name Strength Pharmaceutical form

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Luxembourg Pfizer bv Rivium Westlaan 142 2909 LD, Capelle a/d Ijssel The Netherlands

Ibuprofen Advil Mono Liquid Caps 200 mg Capsule, soft Oral use

Luxembourg Abbott Laboratoires Avenue Einstein 14 1300 Wavre Belgium

Ibuprofen Brufen forte 600 mg Coated tablet Oral use

Luxembourg Abbott Laboratoires Avenue Einstein 14 1300 Wavre Belgium

Ibuprofen Brufen granules 600 mg Effervescent granules Oral use

Luxembourg Abbott Laboratoires Avenue Einstein 14 1300 Wavre Belgium

Ibuprofen Brufen retard 800 mg Prolonged-release tablet

Oral use

Luxembourg Abbott Laboratoires Avenue Einstein 14 1300 Wavre Belgium

Ibuprofen Brufen 400 mg Coated tablet Oral use

Luxembourg Abbott Laboratoires Avenue Einstein 14 1300 Wavre Belgium

Ibuprofen Brufen granules 400 mg Effervescent granules Oral use

Luxembourg Abbott Laboratoires Avenue Einstein 14 1300 Wavre Belgium

Ibuprofen Brufen suspension buvable

40 mg/ml Oral suspension Oral use

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INN Invented name Strength Pharmaceutical form

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Luxembourg Simons Georg GmbH Eckenheimer Landstr 100 60318 Frankfurt/Main Germany

Ibuprofen Dismenol N 200 mg Coated tablet Oral use

Luxembourg Dolorgiet GmbH & Co. KG Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany

Ibuprofen Dolgit 600 mg Coated tablet Oral use

Luxembourg Dolorgiet GmbH & Co. KG Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany

Ibuprofen Dolgit 800 mg Coated tablet Oral use

Luxembourg Socobom nv/sa Avenue Louise 149b24 1050 Bruxelles Belgium

Ibuprofen Dolofin 200 mg Coated tablet Oral use

Luxembourg Socobom nv/sa Avenue Louise 149b24 1050 Bruxelles Belgium

Ibuprofen Dolofin 200 mg Coated tablet Oral use

Luxembourg Socobom nv/sa Avenue Louise 149b24 1050 Bruxelles Belgium

Ibuprofen Dolofin 200 mg Coated tablet Oral use

Luxembourg Will-Pharma S.A. Rue du Manil 80 1301 Wavre Belgium

Ibuprofen Epsilon 400 mg Coated tablet Oral use

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Luxembourg ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen lysine Ibu Ratiopharm Lysinat 500 mg Coated tablet Oral use

Luxembourg Abz-Pharma GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen lysine Ibu-Lysin Abz Migraene 684 mg Coated tablet Oral use

Luxembourg ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen lysine Ibu-Lysin Ratiopharm 684 mg Coated tablet Oral use

Luxembourg ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen lysine Ibu-Lysin Ratiopharm 342 mg Coated tablet Oral use

Luxembourg CT Arzneimittel GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen lysine Ibu-Lysin CT 684 mg Coated tablet Oral use

Luxembourg CT Arzneimittel GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen lysine Ibu-Lysin CT 342 mg Coated tablet Oral use

Luxembourg ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen Ibu-Ratiopharm 200 mg Coated tablet Oral use

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Luxembourg ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen Ibu-Ratiopharm 400 mg Coated tablet Oral use

Luxembourg ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen Ibu-Ratiopharm 600 mg Coated tablet Oral use

Luxembourg ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen Ibu-Ratiopharm 800 mg Prolonged-release tablet

Oral use

Luxembourg Hexal AG Industriestrasse 25 83607 Holzkirchen Germany

Ibuprofen Ibuhexal retard 800 mg Prolonged-release tablet

Oral use

Luxembourg Hexal AG Industriestrasse 25 83607 Holzkirchen Germany

Ibuprofen Ibuhexal 400 mg Coated tablet Oral use

Luxembourg Hexal AG Industriestrasse 25 83607 Holzkirchen Germany

Ibuprofen Ibuhexal 600 mg Coated tablet Oral use

Luxembourg Hexal AG Industriestrasse 25 83607 Holzkirchen Germany

Ibuprofen Ibuhexal 800 mg Coated tablet Oral use

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Luxembourg ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen Ibuprofen ratio 200 mg Coated tablet Oral use

Luxembourg ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen Ibuprofen ratio 400 mg Coated tablet Oral use

Luxembourg CT Arzneimittel GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen Ibuprofen ct 500 mg Suppository Rectal use

Luxembourg Eurogenerics NV Esplanade Heysel b22 1020 Bruxelles Belgium

Ibuprofen Ibuprofen EG 40 mg/ml Oral suspension Oral use

Luxembourg Eurogenerics NV Esplanade Heysel b22 1020 Bruxelles Belgium

Ibuprofen Ibuprofen EG 400 mg Coated tablet Oral use

Luxembourg Eurogenerics NV Esplanade Heysel b22 1020 Bruxelles Belgium

Ibuprofen Ibuprofen EG 600 mg Coated tablet Oral use

Luxembourg Eurogenerics NV Esplanade Heysel b22 1020 Bruxelles Belgium

Ibuprofen Ibuprofen EG 800 mg Prolonged-release tablet

Oral use

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INN Invented name Strength Pharmaceutical form

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Luxembourg Boehringer Ingelheim International GmbH Binger Straße 173 55216 Ingelheim am Rhein Germany

Ibuprofen Ibuprofen Boehringer Ingelheim

400 mg Capsule, soft Oral use

Luxembourg Mylan bvba/sprl Terhulpsesteenweg 6a 1560 Hoeilaart Belgium

Ibuprofen lysine Ibuprofen Lysine Mylan 200 mg Coated tablet Oral use

Luxembourg Mylan bvba/sprl Terhulpsesteenweg 6a 1560 Hoeilaart Belgium

Ibuprofen lysine Ibuprofen Lysine Mylan 400 mg Coated tablet Oral use

Luxembourg Mylan bvba/sprl Terhulpsesteenweg 6a 1560 Hoeilaart Belgium

Ibuprofen lysine Ibuprofen Lysine Mylan Pharma

200 mg Coated tablet Oral use

Luxembourg Mylan bvba/sprl Terhulpsesteenweg 6a 1560 Hoeilaart Belgium

Ibuprofen lysine Ibuprofen Lysine Mylan Pharma

400 mg Coated tablet Oral use

Luxembourg Sandoz nv/sa Telecom Gardens Medialaan 40 1800 Vilvoorde Belgium

Ibuprofen Ibuprofen Sandoz 40 mg/ml Oral suspension Oral use

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INN Invented name Strength Pharmaceutical form

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Luxembourg Abbott S.A-N.V. Avenue Einstein 14 1300 Wavre Belgium

Ibuprofen Malafene 100mg/5ml 20 mg/ml Syrup Oral use

Luxembourg Reckitt Benckiser Healthcare nv/sa Allée de la recherche 20 1070 Bruxelles Belgium

Ibuprofen Nurofen fastcaps 200 mg Capsule, soft Oral use

Luxembourg Reckitt Benckiser Healthcare nv/sa Allée de la recherche 20 1070 Bruxelles Belgium

Ibuprofen Nurofen fastpowder 400 mg Powder for oral solution

Oral use

Luxembourg Reckitt Benckiser Healthcare nv/sa Allée de la recherche 20 1070 Bruxelles Belgium

Ibuprofen Nurofen fasttabs 684 mg Film-coated tablet Oral use

Luxembourg Reckitt Benckiser Healthcare nv/sa Allée de la recherche 20 1070 Bruxelles Belgium

Ibuprofen Nurofen 200 mg Coated tablet Oral use

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INN Invented name Strength Pharmaceutical form

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Luxembourg Reckitt Benckiser Healthcare nv/sa Allée de la recherche 20 1070 Bruxelles Belgium

Ibuprofen Nurofen 400 400 mg Coated tablet Oral use

Luxembourg Reckitt Benckiser Healthcare nv/sa Allée de la recherche 20 1070 Bruxelles Belgium

Ibuprofen lysine Nurofen lysine 342 mg Film-coated tablet Oral use

Luxembourg Reckitt Benckiser Healthcare nv/sa Allée de la recherche 20 1070 Bruxelles Belgium

Ibuprofen lysine Nurofen lysine 684 mg Film-coated tablet Oral use

Luxembourg Johnson & Johnson Consumer SA/NV Antwerpseweg 15-17 2340 Beerse Belgium

Ibuprofen lysine Perdofemina 684 mg Film-coated tablet Oral use

Luxembourg Johnson & Johnson Consumer SA/NV Antwerpseweg 15-17 2340 Beerse Belgium

Ibuprofen lysine Perdophen 684 mg Coated tablet Oral use

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INN Invented name Strength Pharmaceutical form

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Luxembourg Dolorgiet GmbH & Co. KG Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany

Ibuprofen Schmerz-Dolgit 400 mg Capsule, soft Oral use

Luxembourg Zambon SA/NV E.Demunterlaan 1/9 1090 Brussels Belgium

Ibuprofen Spidifen 200 mg Granules for oral solution

Oral use

Luxembourg Zambon SA/NV E.Demunterlaan 1/9 1090 Brussels Belgium

Ibuprofen Spidifen 200 mg Tablet Oral use

Luxembourg Zambon SA/NV E.Demunterlaan 1/9 1090 Brussels Belgium

Ibuprofen Spidifen 200 mg Effervescent tablet Oral use

Luxembourg Zambon SA/NV E.Demunterlaan 1/9 1090 Brussels Belgium

Ibuprofen Spidifen 400 mg Film-coated tablet Oral use

Malta Mepha Lda. Lagoas Park, 2740-298 Porto Salvo Portugal

Ibuprofen Irfen-200 Quiktabs 200 mg Film-coated tablet Oral use

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Malta Reckitt Benckiser Healthcare International Ltd. Thane Road Nottingham NG90 2DB United Kingdom

Ibuprofen Nurofen 200mg 200 mg Coated tablet Oral use

Malta Reckitt Benckiser Healthcare International Ltd. Thane Road Nottingham NG90 2DB United Kingdom

Ibuprofen Nurofen Express Capsules, Soft 200mg

200 mg Capsule, soft Oral use

Malta Reckitt Benckiser Healthcare International Ltd. Thane Road Nottingham NG90 2DB United Kingdom

Ibuprofen/Pseudoephedrine hydrochloride

NUROFEN COLD AND FLU TABLETS

200 mg/30mg

Coated tablet Oral use

Malta Fair-Med Healthcare GmbH Planckstr. 13 22765 Hamburg Germany

Ibuprofen Ibuprofen FAIR-MED 200 mg film-coated tablet

200 mg Film-coated tablet Oral use

Malta A. C. R. A. F. SpA (Aziende Chimiche Riunite Angelini Francesco) Viale Amelia 70, Rome 00181 Italy

Ibuprofen Moment 200 200 mg Coated tablet Oral use

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Malta Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Ibuprofen Actavis 200mg Film-Coated Tablets

200 mg Coated tablet Oral use

Malta Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Ibufen Coated Tablets 200mg

200 mg Coated tablet Oral use

Malta A. C. R. A. F. SpA (Aziende Chimiche Riunite Angelini Francesco) Viale Amelia 70, Rome 00181 Italy

Ibuprofen Moment 200 200 mg/ml Oral drops, solution Oral use

Malta Fair-Med Healthcare GmbH Planckstr. 13 22765 Hamburg Germany

Ibuprofen Ibuprofen FAIR-MED 400 mg film-coated tablet

400 mg Film-coated tablet Oral use

Malta Goldshield Pharmaceuticals Ltd NLA Tower 12-16 Addiscombe Road Croydon Surrey CR0 OXT United Kingdom

Ibuprofen Fenbid Spansule Capsules

300 mg Modified-release capsule

Oral use

192

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INN Invented name Strength Pharmaceutical form

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Malta Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Ibuprofen Actavis 400mg Film-Coated Tablets

400 mg Coated tablet Oral use

Malta Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Ibufen Coated Tablets 400mg

400 mg Coated tablet Oral use

Malta Dolorgiet GmbH & Co. KG Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany

Ibuprofen Dolgit 600 600 mg Coated tablet Oral use

Malta Fair-Med Healthcare GmbH Planckstr. 13 22765 Hamburg Germany

Ibuprofen Ibuprofen FAIR-MED 600 mg film-coated tablet

600 mg Film-coated tablet Oral use

Malta Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Ibuprofen Actavis 600mg Film-Coated Tablets

600 mg Coated tablet Oral use

Malta Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Ibuprofen Actavis 800mg Film-Coated Tablets

800 mg Coated tablet Oral use

193

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INN Invented name Strength Pharmaceutical form

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Malta Omega Pharma Ltd 1st Floor Vauxhall Bridge Road 32 London SW1V 2SA United Kingdom

Ibuprofen codeine phosphate hemihydrate

Solpadeine Migraine Ibuprofen & Codeine Tablets

200 mg Film-coated tablet Oral use

Malta Reckitt Benckiser Healthcare International Ltd. Thane Road Nottingham NG90 2DB United Kingdom

Ibuprofen codeine phosphate hemihydrate

Nurofen Plus 200 mg Tablet Oral use

Malta Pfizer Healthcare Ireland 9 Riverwalk National Digital Park Citywest Business Campus Dublin 24 Ireland

Ibuprofen pseudoephedrine hydrochloride

Advil Cold & Flu Coated Tablets

200 mg Coated tablet Oral use

Malta Reckitt Benckiser Healthcare International Ltd. Thane Road Nottingham NG90 2DB United Kingdom

Ibuprofen pseudoephedrine hydrochloride

Lemsip Flu 12Hr Ibuprofen + Pseudoephedrine

300 mg Modified-release capsule

Oral use

Malta Dr. Max Pharma Ltd. First Floor Roxburge House, Regent Street 273-287 W1B 2HA London United Kingdom

Ibuprofen Ibuprofen Dr. Max 200mg

200 mg Film-coated tablet Oral use

194

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INN Invented name Strength Pharmaceutical form

Route of administration

Malta Dr. Max Pharma Ltd. First Floor Roxburge House, Regent Street 273-287 W1B 2HA London United Kingdom

Ibuprofen Ibuprofen Dr. Max 400mg

400 mg Film-coated tablet Oral use

Norway Abbott Scandinavia AB P.O Box 1498 SE-171 29 Solna Sweden

Ibuprofen Brufen Retard 800 mg Prolonged-release tablet

Oral use

Norway Infirst Healthcare Ltd. Strand 265 London WC2R 1BH United Kingdom

Ibuprofen Flarin 400 mg Capsule, soft Oral use

Norway Infirst Healthcare Ltd. Strand 265 London WC2R 1BH United Kingdom

Ibuprofen Flarin 200 mg Capsule, soft Oral use

Norway Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibuprofen Ibumax 400 mg Film-coated tablet Oral use

Norway Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibuprofen Ibumax 200 mg Film-coated tablet Oral use

195

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INN Invented name Strength Pharmaceutical form

Route of administration

Norway Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibuprofen Ibumax 600 mg Film-coated tablet Oral use

Norway Takeda Nycomed AS P.O. Box 205 NO-1372 Asker Norway

Ibuprofen Ibumetin 600 mg Tablet Oral use

Norway Takeda Nycomed AS P.O. Box 205 NO-1372 Asker Norway

Ibuprofen Ibumetin 400 mg Tablet Oral use

Norway Takeda Nycomed AS P.O. Box 205 NO-1372 Asker Norway

Ibuprofen Ibumetin 200 mg Tablet Oral use

Norway Takeda Nycomed AS P.O. Box 205 NO-1372 Asker Norway

Ibuprofen Ibumetin 20 mg/ml Oral suspension Oral use

Norway Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofen Ibuprofen Farmalider 40 mg/ml Oral suspension Oral use

Norway Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofen Ibuprofen Farmalider 20 mg/ml Oral suspension Oral use

196

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INN Invented name Strength Pharmaceutical form

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Norway Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

Ibuprofen Ibuprofen Orion 400 mg Film-coated tablet Oral use

Norway Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

Ibuprofen Ibuprofen Orion 200 mg Film-coated tablet Oral use

Norway ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen Ibuprofen ratiopharm 400 mg Film-coated tablet Oral use

Norway ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen Ibuprofen ratiopharm 200 mg Film-coated tablet Oral use

Norway ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen Ibuprofen ratiopharm 600 mg Film-coated tablet Oral use

197

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INN Invented name Strength Pharmaceutical form

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Norway Weifa AS P.O.Box 6733 Etterstad NO-0609 Oslo Norway

Ibuprofen Ibux 600 mg Suppository Rectal use

Norway Weifa AS P.O.Box 6733 Etterstad NO-0609 Oslo Norway

Ibuprofen Ibux 600 mg Film-coated tablet Oral use

Norway Weifa AS P.O.Box 6733 Etterstad NO-0609 Oslo Norway

Ibuprofen Ibux 400 mg Film-coated tablet Oral use

Norway Weifa AS P.O.Box 6733 Etterstad NO-0609 Oslo Norway

Ibuprofen Ibux 200 mg Film-coated tablet Oral use

Norway Weifa AS P.O.Box 6733 Etterstad NO-0609 Oslo Norway

Ibuprofen Ibux 200 mg Capsule, soft Oral use

Norway Weifa AS P.O.Box 6733 Etterstad NO-0609 Oslo Norway

Ibuprofen Ibux 400 mg Capsule, soft Oral use

Norway Weifa AS P.O.Box 6733 Etterstad NO-0609 Oslo Norway

Ibuprofen Ibux 20 mg/ml Oral suspension Oral use

198

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Norway Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Ifenin 400 mg Film-coated tablet Oral use

Norway Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Ifenin 200 mg Film-coated tablet Oral use

Poland Teva Pharmaceuticals Polska Sp.z o.o. 53 Emilii Plater st. 00-113 Warsaw Poland

Ibuprofen Ibuprofen 123ratio 200 mg Film-coated tablet Oral use

Poland Teva Pharmaceuticals Polska Sp.z o.o. 53 Emilii Plater st. 00-113 Warsaw Poland

Ibuprofen Ibuprofen 123ratio 400 mg Film-coated tablet Oral use

Poland BGP Products Poland Sp. z o.o. Postepu st. 21B 02-676 Warsaw Poland

Ibuprofen Brufen 400 mg Effervescent granules Oral use

Poland BGP Products Poland Sp. z o.o. Postepu st. 21B 02-676 Warsaw Poland

Ibuprofen Brufen 20 mg/ml Oral suspension Oral use

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INN Invented name Strength Pharmaceutical form

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Poland BGP Products Poland Sp. z o.o. Postepu st. 21B 02-676 Warsaw Poland

Ibuprofen Brufen Forte 40 mg/ml Oral suspension Oral use

Poland BGP Products Poland Sp. z o.o. Postepu st. 21B 02-676 Warsaw Poland

Ibuprofen ABFEN 200 mg Effervescent granules Oral use

Poland Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Ifenin 200 mg Film-coated tablet Oral use

Poland Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Ifenin Forte 400 mg Film-coated tablet Oral use

Poland Aflofarm Farmacja Polska Sp. z o.o. Partyzancka st. 133/151 95-200 Pabianice Poand

Ibuprofen Ibuprofen AFL 200 mg Coated tablet Oral use

Poland Aflofarm Farmacja Polska Sp. z o.o. Partyzancka st. 133/151 95-200 Pabianice Poand

Ibuprofen Ibuprofen Aflofarm 400 mg Coated tablet Oral use

200

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INN Invented name Strength Pharmaceutical form

Route of administration

Poland Aflofarm Farmacja Polska Sp. z o.o. Partyzancka st. 133/151 95-200 Pabianice Poand

Ibuprofen Ibuprofen Aflofarm 200 mg Coated tablet Oral use

Poland Aflofarm Farmacja Polska Sp. z o.o. Partyzancka st. 133/151 95-200 Pabianice Poand

Ibuprofen paracetamol

Kidofen Duo (100 mg + 125 mg)/5 ml

Oral suspension Oral use

Poland APC Instytut Sp. z o.o. Grójecka st. 22/24 lok. 4 02-301 Warsaw Poland

Ibuprofen Galprofen 200 mg Coated tablet Oral use

Poland APC Instytut Sp. z o.o. Grójecka st. 22/24 lok. 4 02-301 Warsaw Poland

Ibuprofen Galprofen Max 400 mg Coated tablet Oral use

Poland APC Instytut Sp. z o.o. Grójecka st. 22/24 lok. 4 02-301 Warsaw Poland

Ibuprofen Ibuprofen APC 200 mg Coated tablet Oral use

Poland APC Instytut Sp. z o.o. Grójecka st. 22/24 lok. 4 02-301 Warsaw Poland

Ibuprofen Ibuprofen APC Max 400 mg Coated tablet Oral use

201

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Poland APC Instytut Sp. z o.o. Grójecka st. 22/24 lok. 4 02-301 Warsaw Poland

Ibuprofen Tesprofen 200 mg Coated tablet Oral use

Poland Banner Pharmacaps Europe B.V. De Posthoornstraat 7 5048 AS Tilburg The Netherlands

Ibuprofen Ibuprofen Banner 400 mg Capsule, soft Oral use

Poland Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany

Ibuprofen MIG 400 mg Film-coated tablet Oral use

Poland Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany

Ibuprofen MIG dla dzieci Forte o smaku truskawkowym

40 mg/ml Oral suspension Oral use

Poland Biofarm Sp. z o.o. Wałbrzyska st. 13 60-198 Poznan Poland

Dexibuprofen Seractil 200 mg Film-coated tablet Oral use

Poland Biofarm Sp. z o.o. Wałbrzyska st. 13 60-198 Poznan Poland

Dexibuprofen Seractil 400 mg Film-coated tablet Oral use

202

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Poland Bio-Profil Polska Sp. z o.o. 135 Trakt Lubelsi st. 04-790 Warsaw Poalnd

Ibuprofen pseudoephedrine hydrochloride

Rinafen Zatoki 200 mg 30 mg

Tablet Oral use

Poland Boehringer Ingelheim International GmbH Binger Straße 173 55216 Ingelheim am Rhein Germany

Ibuprofen Buscofem 400 mg Capsule, soft Oral use

Poland Fair-Med Healthcare GmbH Planckstr. 13 22765 Hamburg Germany

Ibuprofen Ibuprofen Fair-Med 200 mg Film-coated tablet Oral use

Poland Fair-Med Healthcare GmbH Planckstr. 13 22765 Hamburg Germany

Ibuprofen Ibuprofen Fair-Med 400 mg Film-coated tablet Oral use

Poland Fair-Med Healthcare GmbH Planckstr. 13 22765 Hamburg Germany

Ibuprofen Ibuprofen Fair-Med 600 mg Film-coated tablet Oral use

Poland Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofen Ibuprofen Farmalider 20 mg/ml Oral suspension Oral use

203

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Poland SEQUOIA Sp. z o.o. Ostródzka 74N 03-289 Warsaw Poland

Ibuprofen Ibuprofen Liderfarm 20 mg/ml Oral suspension Oral use

Poland Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

Ibuprofen Ibuprofen Galpharm 200 mg Film-coated tablet Oral use

Poland Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

Ibuprofen Ibuprofen Galpharm 400 mg Film-coated tablet Oral use

Poland Laboratorium Galenowe Olsztyn Sp. z o.o. Spóldzielcza st. 25A 11-001 Dywity Poland

Ibuprofen Ibuprofen LGO 400 mg Film-coated tablet Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Poland Laboratorium Galenowe Olsztyn Sp. z o.o. Spóldzielcza st. 25A 11-001 Dywity Poland

Ibuprofen Ibuprofen LGO 200 mg Film-coated tablet Oral use

Poland Pabianickie Zakłady Farmaceutyczne Polfa S.A. Marszalka Pilsudskiego st. 5 95-200 Pabianice Poland

Ibuprofen Ibupar 200 mg Coated tablet Oral use

Poland Pabianickie Zakłady Farmaceutyczne Polfa S.A. Marszalka Pilsudskiego st. 5 95-200 Pabianice Poland

Ibuprofen Ibupar forte 400 mg Film-coated tablet Oral use

Poland Pabianickie Zakłady Farmaceutyczne Polfa S.A. Marszalka Pilsudskiego st. 5 95-200 Pabianice Poland

Ibuprofen Ibuprofen-Pabi 200 mg Coated tablet Oral use

Poland Polfarmex S.A. 9 Józefów st, 99-300 Kutno Poland

Ibuprofen Ibuprofen Polfarmex 200 mg Film-coated tablet Oral use

205

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Poland Przedsiębiorstwo Produkcji Farmaceutycznej HASCO-LEK S.A. 242E Żmigroddzka st,. 51-131 Wroclaw Poland

Ibuprofen Ibum 200 mg Capsule, soft Oral use

Poland Przedsiębiorstwo Produkcji Farmaceutycznej HASCO-LEK S.A. 242E Żmigroddzka st,. 51-131 Wroclaw Poland

Ibuprofen Ibum 20 mg/ml Oral suspension Oral use

Poland Przedsiębiorstwo Produkcji Farmaceutycznej HASCO-LEK S.A. 242E Żmigroddzka st,. 51-131 Wroclaw Poland

Ibuprofen Ibum 20 mg/ml Oral suspension Oral use

Poland Przedsiębiorstwo Produkcji Farmaceutycznej HASCO-LEK S.A. 242E Żmigroddzka st,. 51-131 Wroclaw Poland

Ibuprofen Ibum Forte 400 mg Capsule, soft Oral use

206

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Poland Przedsiębiorstwo Produkcji Farmaceutycznej HASCO-LEK S.A. 242E Żmigroddzka st,. 51-131 Wroclaw Poland

Ibuprofen Ibum Forte Minicaps 400 mg Capsule, soft Oral use

Poland Przedsiębiorstwo Produkcji Farmaceutycznej HASCO-LEK S.A. 242E Żmigroddzka st,. 51-131 Wroclaw Poland

Ibuprofen pseudoephedrine hydrochloride

Ibum Grip 200 mg 30 mg

Film-coated tablet Oral use

Poland Przedsiębiorstwo Produkcji Farmaceutycznej HASCO-LEK S.A. 242E Żmigroddzka st,. 51-131 Wroclaw Poland

Ibuprofen pseudoephedrine hydrochloride

Ibum Zatoki 200 mg 30 mg

Film-coated tablet Oral use

Poland Przedsiębiorstwo Produkcji Farmaceutycznej HASCO-LEK S.A. 242E Żmigroddzka st,. 51-131 Wroclaw Poland

Ibuprofen Ibuprofen Hasco 200 mg Capsule, soft Oral use

207

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INN Invented name Strength Pharmaceutical form

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Poland Teva Pharmaceuticals Polska Sp.z o.o. 53 Emilii Plater st. 00-113 Warsaw Poland

Ibuprofen Bufenik 40 mg/ml Syrup Oral use

Poland Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

Ibuprofen Nurofen 200 mg Film-coated tablet Oral use

Poland Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

Ibuprofen Nurofen Caps 400 mg Capsule, soft Oral use

Poland Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

Ibuprofen Nurofen dla dzieci Forte 40 mg/ml Oral suspension Oral use

208

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Poland Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

Ibuprofen Nurofen dla dzieci o smaku truskawkowym

20 mg/ml Oral suspension Oral use

Poland Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

Ibuprofen Nurofen Express 200 mg Film-coated tablet Oral use

Poland Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

Ibuprofen Nurofen Express Femina

200 mg Capsule, soft Oral use

Poland Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

Ibuprofen Nurofen Express Forte rozpuszczalny

400 mg Oral powder Oral use

209

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Poland Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

Ibuprofen Nurofen Express TAB 400 mg

400 mg Film-coated tablet Oral use

Poland Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

Ibuprofen Nurofen Forte Express 400 mg Film-coated tablet Oral use

Poland Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

Ibuprofen Nurofen na ból pleców 300 mg Prolonged-realease capsule

Oral use

Poland Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

Ibuprofen codeine phosphate

Nurofen Plus 200 mg 12,8 mg

Film-coated tablet Oral use

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Poland Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

Ibuprofen pseudoephedrine hydrochloride

Nurofen Zatoki 200 mg 30 mg

Film-coated tablet Oral use

Poland Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwor Mazowiecki Poland

Ibuprofen paracetamol

Nurofen Ultima 200 mg 500 mg

Film-coated tablet Oral use

Poland Rockspring Healthcare Limited 38/40 Chamberlayne Road London NW10 3JE United Kingdom

Ibuprofen codeine phosphate hemihydrate

Brufen Plus 400 mg 30 mg

Film-coated tablet Oral use

Poland US Pharmacia Sp. z o.o. Ziebicka st. 40 50-507 Wroclaw Poalnd

Ibuprofen pseudoephedrine hydrochloride

Acatar Zatoki 200 mg 30 mg

Film-coated tablet Oral use

Poland US Pharmacia Sp. z o.o. Ziebicka st. 40 50-507 Wroclaw Poalnd

Ibuprofen pseudoephedrine hydrochloride

Acatar Zatoki Tabs 200 mg 6,1 mg

Coated tablet Oral use

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Poland US Pharmacia Sp. z o.o. Ziebicka st. 40 50-507 Wroclaw Poalnd

Ibuprofen Ibuprom 200 mg Film-coated tablet Oral use

Poland US Pharmacia Sp. z o.o. Ziebicka st. 40 50-507 Wroclaw Poalnd

Ibuprofen Ibuprom DUO 400 mg Film-coated tablet Oral use

Poland US Pharmacia Sp. z o.o. Ziebicka st. 40 50-507 Wroclaw Poalnd

Ibuprofen Ibuprom Max 400 mg Coated tablet Oral use

Poland US Pharmacia Sp. z o.o. Ziebicka st. 40 50-507 Wroclaw Poalnd

Ibuprofen Ibuprom Max Sprint 400 mg Capsule, soft Oral use

Poland US Pharmacia Sp. z o.o. Ziebicka st. 40 50-507 Wroclaw Poalnd

Ibuprofen Ibuprom Sprint Caps 200 mg Capsule, soft Oral use

Poland US Pharmacia Sp. z o.o. Ziebicka st. 40 50-507 Wroclaw Poalnd

Ibuprofen pseudoephedrine hydrochloride

Ibuprom Zatoki 200 mg 30 mg

Film-coated tablet Oral use

Poland US Pharmacia Sp. z o.o. Ziebicka st. 40 50-507 Wroclaw Poalnd

Ibuprofen phenylephrine hydrochloride

Ibuprom Zatoki Tabs 200 mg 6,1 mg

Coated tablet Oral use

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Poland Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibuprofen Ibumax 200 mg 200 mg Film-coated tablet Oral use

Poland Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibuprofen Ibumax 400 mg 400 mg Film-coated tablet Oral use

Poland Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibuprofen Ibumax Forte 600 mg 600 mg Film-coated tablet Oral use

Poland Wrafton Laboratories Limited Exeter Road Wrafton Braunton Devon EX33 2DL United Kingdom

Ibuprofen Ibuprofen Lysine Perrigo

400 mg Film-coated tablet Oral use

Poland Wrafton Laboratories Limited Exeter Road Wrafton Braunton Devon EX33 2DL United Kingdom

Ibuprofen Ibuprofen Lysine Perrigo

200 mg Film-coated tablet Oral use

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Poland Zakłady Farmaceutyczne POLPHARMA S.A. Pelpinska St. 19 83-200 Starogard Gdanski Poland

Ibuprofen Ibufen dla dzieci FORTE o smaku truskawkowym

40 mg/ml Oral suspension Oral use

Poland Zakłady Farmaceutyczne POLPHARMA S.A. Pelpinska St. 19 83-200 Starogard Gdanski Poland

Ibuprofen Ibufen Junior 200 mg Capsule, soft Oral use

Poland Zakłady Farmaceutyczne POLPHARMA S.A. Pelpinska St. 19 83-200 Starogard Gdanski Poland

Ibuprofen paracetamol

Metafen 200 mg 325 mg

Tablet Oral use

Poland Zakłady Farmaceutyczne POLPHARMA S.A. Pelpinska St. 19 83-200 Starogard Gdanski Poland

Ibuprofen pseudoephedrine hydrochloride

Metafen Zatoki 200 mg 30 mg

Tablet Oral use

Poland Zambon S.p.A. Via Lillo del Duca 10 20091, Bresso (Mi) Italy

Ibuprofen Spedifen 400 400 mg Film-coated tablet Oral use

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Poland Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Ibuprofen Ibalgin 200 mg Film-coated tablet Oral use

Poland Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Ibuprofen Ibalgin Fast 400 mg Film-coated tablet Oral use

Poland Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Ibuprofen Ibalgin Maxi 400 mg Film-coated tablet Oral use

Poland Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Ibuprofen pseudoephedrine hydrochloride

Modafen 200 mg 30 mg

Film-coated tablet Oral use

Poland Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Ibuprofen phenylephrine hydrochloride

Modafen Grip 200 mg 5 mg

Film-coated tablet Oral use

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Poland Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Ibuprofenum Modafen baby 100 mg/5 ml Oral suspension Oral use

Portugal Abbott Laboratórios, Lda. Estrada de Alfragide, 67 - Alfrapark - Edificio D 2610-008 Amadora Portugal

Ibuprofen Brufen 200 mg Effervescent granules Oral use

Portugal Abbott Laboratórios, Lda. Estrada de Alfragide, 67 - Alfrapark - Edificio D 2610-008 Amadora Portugal

Ibuprofen Brufen 200 mg Film-coated tablet Oral use

Portugal Abbott Laboratórios, Lda. Estrada de Alfragide, 67 - Alfrapark - Edificio D 2610-008 Amadora Portugal

Ibuprofen Brufen 600 mg Effervescent granules Oral use

Portugal Abbott Laboratórios, Lda. Estrada de Alfragide, 67 - Alfrapark - Edificio D 2610-008 Amadora Portugal

Ibuprofen Brufen 400 mg Effervescent granules Oral use

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Portugal Abbott Laboratórios, Lda. Estrada de Alfragide, 67 - Alfrapark - Edificio D 2610-008 Amadora Portugal

Ibuprofen Brufen 600 mg Film-coated tablet Oral use

Portugal Abbott Laboratórios, Lda. Estrada de Alfragide, 67 - Alfrapark - Edificio D 2610-008 Amadora Portugal

Ibuprofen Brufen 400 mg Film-coated tablet Oral use

Portugal Abbott Laboratórios, Lda. Estrada de Alfragide, 67 - Alfrapark - Edificio D 2610-008 Amadora Portugal

Ibuprofen Brufen Retard 800 mg Prolonged-release tablet

Oral use

Portugal Abbott Laboratórios, Lda. Estrada de Alfragide, 67 - Alfrapark - Edificio D 2610-008 Amadora Portugal

Ibuprofen Brufen Sem Açúcar 40 mg/ml Oral suspension Oral use

Portugal Abbott Laboratórios, Lda. Estrada de Alfragide, 67 - Alfrapark - Edificio D 2610-008 Amadora Portugal

Ibuprofen Brufen Suspensão 20 mg/ml Oral suspension Oral use

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INN Invented name Strength Pharmaceutical form

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Portugal Boehringer Ingelheim, Lda. Avenida de Pádua, 11 1800-294 Lisboa Portugal

Ibuprofen Buskofem 200 mg Capsule, soft Oral use

Portugal Boehringer Ingelheim International GmbH Binger Straße 173 55216 Ingelheim am Rhein Germany

Ibuprofen Buskofem 400 mg Capsule, soft Oral use

Portugal Laboratórios Basi - Indústria Farmacêutica, S.A Parque Industrial Manuel Lourenço Ferreira, Lote 15 3450-232 Mortágua Portugal

Ibuprofen Dimidon 400 mg Film-coated tablet Oral use

Portugal Novartis Consumer Health - Produtos Farmacêuticos e Nutrição, Lda. Avenida Professor Doutor Cavaco Silva, 10 E, Taguspark 2740-255 Porto Salvo Portugal

Ibuprofen Dolocyl 200 mg Coated tablet Oral use

Portugal Jaba Recordati, S. A. Lagoas Park, Edificio 5, Torre C, Piso 3 2740-298 Porto Salvo Portugal

Ibuprofen Dolomate 200 200 mg Powder for oral suspension

Oral use

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Portugal Zambon - Produtos Farmacêuticos, Lda. Rua Comandante Enrique Maya, 1 1500-192 Lisboa Portugal

Ibuprofen Faspic 200 200 mg Granules for oral solution

Oral use

Portugal Zambon - Produtos Farmacêuticos, Lda. Rua Comandante Enrique Maya, 1 1500-192 Lisboa Portugal

Ibuprofen Faspic 400 400 mg Granules for oral solution

Oral use

Portugal Zambon - Produtos Farmacêuticos, Lda. Rua Comandante Enrique Maya, 1 1500-192 Lisboa Portugal

Ibuprofen Faspic 600 600 mg Granules for oral solution

Oral use

Portugal Zambon - Produtos Farmacêuticos, Lda. Rua Comandante Enrique Maya, 1 1500-192 Lisboa Portugal

Ibuprofen Fenpic 400 mg Film-coated tablet Oral use

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INN Invented name Strength Pharmaceutical form

Route of administration

Portugal Confar - Consórcio Farmacêutico, Lda. Rua Félix Correia, 1-B 1500-271 Lisboa Portugal

Ibuprofen Frenidor 200 mg Coated tablet Oral use

Portugal Confar - Consórcio Farmacêutico, Lda. Rua Félix Correia, 1-B 1500-271 Lisboa Portugal

Ibuprofen Frenidor 200 mg Granules Oral use

Portugal Bene Farmacêutica, Lda. Avenida D. João II, Lote 1.06.2.2.C - 1º B 1990-095 Lisboa Portugal

Ibuprofen Ib-u-ron 600 mg Film-coated tablet Oral use

Portugal Bene Farmacêutica, Lda. Avenida D. João II, Lote 1.06.2.2.C - 1º B 1990-095 Lisboa Portugal

Ibuprofen Ib-u-ron 40 mg/ml Oral suspension Oral use

Portugal Bene Farmacêutica, Lda. Avenida D. João II, Lote 1.06.2.2.C - 1º B 1990-095 Lisboa Portugal

Ibuprofen Ib-u-ron 400 mg Film-coated tablet Oral use

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INN Invented name Strength Pharmaceutical form

Route of administration

Portugal BGP Products, Unipessoal, Lda. Estrada de Alfragide, 67 - Alfrapark, Edificio D 2610-008 Amadora Portugal

Ibuprofen Ibuprofeno Premier 600 mg Film-coated tablet Oral use

Portugal BGP Products, Unipessoal, Lda. Estrada de Alfragide, 67 - Alfrapark, Edificio D 2610-008 Amadora Portugal

Ibuprofen Ibuprofeno Premier 400 mg Film-coated tablet Oral use

Portugal Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Ibuprofeno Actavis 800 mg Film-coated tablet Oral use

Portugal Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Ibuprofeno Actavis 400 mg Film-coated tablet Oral use

Portugal Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Ibuprofeno Actavis 200 mg Film-coated tablet Oral use

Portugal Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Ibuprofeno Actavis 600 mg Film-coated tablet Oral use

221

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INN Invented name Strength Pharmaceutical form

Route of administration

Portugal Alter, S.A. Estrada Marco do Grilo - Zemouto 2830 Coina Portugal

Ibuprofen Ibuprofeno Alter 400 mg Comprimidos revestidos

400 mg Film-coated tablet Oral use

Portugal Alter, S.A. Estrada Marco do Grilo - Zemouto 2830 Coina Portugal

Ibuprofen Ibuprofeno Alter 600 mg Comprimidos Revestidos

600 mg Film-coated tablet Oral use

Portugal Laboratórios Azevedos - Indústria Farmacêutica, S.A. Edifícios Azevedos - Estrada Nacional 117-2, Alfragide 2614-504 Amadora Portugal

Ibuprofen Ibuprofeno Azevedos 400 mg Comprimidos

400 mg Film-coated tablet Oral use

Portugal Laboratórios Azevedos - Indústria Farmacêutica, S.A. Edifícios Azevedos - Estrada Nacional 117-2, Alfragide 2614-504 Amadora Portugal

Ibuprofen Ibuprofeno Azevedos 600 mg Comprimidos

600 mg Film-coated tablet Oral use

222

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Portugal Ciclum Farma Unipessoal, Lda. Quinta da Fonte, Rua Vitor Câmara, 2 - Edifício D. Amélia, Piso 1, Ala B 2770-229 Paço de Arcos Portugal

Ibuprofen Ibuprofeno Ciclum 600 mg Film-coated tablet Oral use

Portugal Ciclum Farma Unipessoal, Lda. Quinta da Fonte, Rua Vitor Câmara, 2 - Edifício D. Amélia, Piso 1, Ala B 2770-229 Paço de Arcos Portugal

Ibuprofen Ibuprofeno Ciclum 400 mg Film-coated tablet Oral use

Portugal Cinfa Portugal, Lda. Av. Tomás Ribeiro, 43 - Bloco 2, 3º F - Edifício Neopark 2790-221 Carnaxide Portugal

Ibuprofen Ibuprofeno Cinfa 400 mg Film-coated tablet Oral use

Portugal Cinfa Portugal, Lda. Av. Tomás Ribeiro, 43 - Bloco 2, 3º F - Edifício Neopark 2790-221 Carnaxide Portugal

Ibuprofen Ibuprofeno Cinfa 600 mg Film-coated tablet Oral use

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INN Invented name Strength Pharmaceutical form

Route of administration

Portugal Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofen Ibuprofeno Codramol 200 mg Granules for oral solution

Oral use

Portugal Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofen Ibuprofeno Codramol 400 mg Film-coated tablet Oral use

Portugal Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofen Ibuprofeno Codramol 600 mg Film-coated tablet Oral use

Portugal Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofen Ibuprofeno Farmalider 200 mg Granules for oral solution

Oral use

Portugal Farmoz - Sociedade Técnico Medicinal, S.A. Rua da Tapada Grande, 2 Abrunheira 2710-089 Sintra Portugal

Ibuprofen Ibuprofeno Farmoz 200 mg Film-coated tablet Oral use

Portugal Farmoz - Sociedade Técnico Medicinal, S.A. Rua da Tapada Grande, 2 Abrunheira 2710-089 Sintra Portugal

Ibuprofen Ibuprofeno Farmoz 400 mg Film-coated tablet Oral use

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INN Invented name Strength Pharmaceutical form

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Portugal Generis Farmacêutica, S.A. Rua João de Deus, 19 2700-487 Amadora Portugal

Ibuprofen Ibuprofeno Generis 600 mg Granules for oral solution

Oral use

Portugal Generis Farmacêutica, S.A. Rua João de Deus, 19 2700-487 Amadora Portugal

Ibuprofen Ibuprofeno Generis 400 mg Granules for oral solution

Oral use

Portugal Generis Farmacêutica, S.A. Rua João de Deus, 19 2700-487 Amadora Portugal

Ibuprofen Ibuprofeno Generis 200 mg Coated tablet Oral use

Portugal Generis Farmacêutica, S.A. Rua João de Deus, 19 2700-487 Amadora Portugal

Ibuprofen Ibuprofeno Generis 20 mg/ml Suspensão oral

20 mg/ml Oral suspension Oral use

Portugal Generis Farmacêutica, S.A. Rua João de Deus, 19 2700-487 Amadora Portugal

Ibuprofen Ibuprofeno Generis 400 mg Comprimidos

400 mg Film-coated tablet Oral use

Portugal Generis Farmacêutica, S.A. Rua João de Deus, 19 2700-487 Amadora Portugal

Ibuprofen Ibuprofeno Generis 600 mg Comprimidos Revestidos

600 mg Coated tablet Oral use

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Portugal Germed Farmacêutica, Lda. Rua Alto do Montijo, 13 - 1º Dto - Edifício Monsanto 2790-012 Portela de Carnaxide Portugal

Ibuprofen Ibuprofeno Germed 400 mg Film-coated tablet Oral use

Portugal Germed Farmacêutica, Lda. Rua Alto do Montijo, 13 - 1º Dto - Edifício Monsanto 2790-012 Portela de Carnaxide Portugal

Ibuprofen Ibuprofeno Germed 600 mg Film-coated tablet Oral use

Portugal Labesfal Genéricos, S.A. Avenida Dr. Afonso Costa, 1370 3465-051 Campo de Besteiros Portugal

Ibuprofen Ibuprofeno Labesfal 200 mg Film-coated tablet Oral use

Portugal Labesfal Genéricos, S.A. Avenida Dr. Afonso Costa, 1370 3465-051 Campo de Besteiros Portugal

Ibuprofen Ibuprofeno Labesfal 400 mg Film-coated tablet Oral use

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Portugal Labesfal Genéricos, S.A. Avenida Dr. Afonso Costa, 1370 3465-051 Campo de Besteiros Portugal

Ibuprofen Ibuprofeno Labesfal 600 mg Film-coated tablet Oral use

Portugal Laboratórios Basi - Indústria Farmacêutica, S.A Parque Industrial Manuel Lourenço Ferreira, Lote 15 3450-232 Mortágua Portugal

Ibuprofen Ibuprofeno Mer 600 mg Coated tablet Oral use

Portugal Laboratórios Basi - Indústria Farmacêutica, S.A Parque Industrial Manuel Lourenço Ferreira, Lote 15 3450-232 Mortágua Portugal

Ibuprofen Ibuprofeno Mer 400 mg Coated tablet Oral use

Portugal OM Pharma, S.A. R. da Indústria, 2 - Quinta Grande 2610 - 088 Amadora - Lisboa Portugal

Ibuprofen Ibuprofeno OM Pharma 200 mg Film-coated tablet Oral use

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Portugal Pharmakern Portugal - Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Edifício Atlas II, Av. José Gomes Ferreira, N.º 11 - 3º, Sala 31 - Miraflores 1495-139 Algés Portugal

Ibuprofen Ibuprofeno Pharmakern 400 mg Film-coated tablet Oral use

Portugal Pharmakern Portugal - Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Edifício Atlas II, Av. José Gomes Ferreira, N.º 11 - 3º, Sala 31 - Miraflores 1495-139 Algés Portugal

Ibuprofen Ibuprofeno Pharmakern 600 mg Film-coated tablet Oral use

Portugal Sanofi - Produtos Farmacêuticos, Lda. Empreendimento Lagoas Park Edifício 7, 3º Piso 2740-244 Porto Salvo Portugal

Ibuprofen Ibalgin 400 mg Film-coated tablet Oral use

Portugal Sanofi - Produtos Farmacêuticos, Lda. Empreendimento Lagoas Park Edifício 7, 3º Piso 2740-244 Porto Salvo Portugal

Ibuprofen Ibalgin 200 mg Film-coated tablet Oral use

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INN Invented name Strength Pharmaceutical form

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Portugal Pharmakern Portugal - Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Edifício Atlas II, Av. José Gomes Ferreira, N.º 11 - 3º, Sala 31 - Miraflores 1495-139 Algés Portugal

Ibuprofen Ibuprofeno Pharmakern 20 mg/ml Oral suspension Oral use

Portugal Pharmakern Portugal - Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Edifício Atlas II, Av. José Gomes Ferreira, N.º 11 - 3º, Sala 31 - Miraflores 1495-139 Algés Portugal

Ibuprofen Ibuprofeno Pharmakern 400 mg Effervescent granules Oral use

Portugal Pharmakern Portugal - Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Edifício Atlas II, Av. José Gomes Ferreira, N.º 11 - 3º, Sala 31 - Miraflores 1495-139 Algés Portugal

Ibuprofen Ibuprofeno Pharmakern 200 mg Effervescent granules Oral use

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INN Invented name Strength Pharmaceutical form

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Portugal Pharmakern Portugal - Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Edifício Atlas II, Av. José Gomes Ferreira, N.º 11 - 3º, Sala 31 - Miraflores 1495-139 Algés Portugal

Ibuprofen Ibuprofeno Betude 200 mg Film-coated tablet Oral use

Portugal Pharmakern Portugal - Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Edifício Atlas II, Av. José Gomes Ferreira, N.º 11 - 3º, Sala 31 - Miraflores 1495-139 Algés Portugal

Ibuprofen Ibuprofeno Pharmakern 600 mg Effervescent granules Oral use

Portugal Pharmakern Portugal - Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Edifício Atlas II, Av. José Gomes Ferreira, N.º 11 - 3º, Sala 31 - Miraflores 1495-139 Algés Portugal

Ibuprofen Ibuprofeno Betude 400 mg Film-coated tablet Oral use

230

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Portugal Pharmakern Portugal - Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Edifício Atlas II, Av. José Gomes Ferreira, N.º 11 - 3º, Sala 31 - Miraflores 1495-139 Algés Portugal

Ibuprofen Ibuprofeno Betude 600 mg Film-coated tablet Oral use

Portugal Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofen Ibuprofeno Poindol 600 mg Film-coated tablet Oral use

Portugal Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofen Ibuprofeno Poindol 400 mg Film-coated tablet Oral use

Portugal Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda. Lagoas Park, Edifício 5 A, Piso 2 2740-245 Porto Salvo Portugal

Ibuprofen Ibuprofeno Ratiopharm 200 mg Film-coated tablet Oral use

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Portugal Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda. Lagoas Park, Edifício 5 A, Piso 2 2740-245 Porto Salvo Portugal

Ibuprofen Ibuprofeno Ratiopharm 400 mg Comprimidos Revestidos

400 mg Film-coated tablet Oral use

Portugal Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda. Lagoas Park, Edifício 5 A, Piso 2 2740-245 Porto Salvo Portugal

Ibuprofen Ibuprofeno Ratiopharm 600 mg Comprimidos Revestidos

600 mg Film-coated tablet Oral use

Portugal Sandoz Farmacêutica, Lda. Avenida Professor Doutor Cavaco Silva, 10E - Taguspark 2740-255 Porto Salvo Portugal

Ibuprofen Ibuprofeno Sandoz 400 mg Film-coated tablet Oral use

Portugal Sandoz Farmacêutica, Lda. Avenida Professor Doutor Cavaco Silva, 10E - Taguspark 2740-255 Porto Salvo Portugal

Ibuprofen Ibuprofeno Sandoz 600 mg Film-coated tablet Oral use

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Portugal Sandoz Farmacêutica, Lda. Avenida Professor Doutor Cavaco Silva, 10E - Taguspark 2740-255 Porto Salvo Portugal

Ibuprofen Ibuprofeno Sandoz 200 mg Film-coated tablet Oral use

Portugal ToLife - Produtos Farmacêuticos, S.A. Avenida do Forte, 3 - Edificio Suécia III, Piso 1 2794-093 Carnaxide Portugal

Ibuprofen Ibuprofeno Tolife 200 mg Film-coated tablet Oral use

Portugal ToLife - Produtos Farmacêuticos, S.A. Avenida do Forte, 3 - Edificio Suécia III, Piso 1 2794-093 Carnaxide Portugal

Ibuprofen Ibuprofeno Tolife 400 mg Film-coated tablet Oral use

Portugal ToLife - Produtos Farmacêuticos, S.A. Avenida do Forte, 3 - Edificio Suécia III, Piso 1 2794-093 Carnaxide Portugal

Ibuprofen Ibuprofeno Tolife 600 mg Granules for oral solution

Oral use

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Portugal ToLife - Produtos Farmacêuticos, S.A. Avenida do Forte, 3 - Edificio Suécia III, Piso 1 2794-093 Carnaxide Portugal

Ibuprofen Ibuprofeno Tolife 400 mg Granules for oral solution

Oral use

Portugal ToLife - Produtos Farmacêuticos, S.A. Avenida do Forte, 3 - Edificio Suécia III, Piso 1 2794-093 Carnaxide Portugal

Ibuprofen Ibuprofeno Tolife 600 mg Film-coated tablet Oral use

Portugal Sanofi - Produtos Farmacêuticos, Lda. Empreendimento Lagoas Park Edifício 7, 3º Piso 2740-244 Porto Salvo Portugal

Ibuprofen Ibuprofeno Zentiva 400 mg Film-coated tablet Oral use

Portugal Farbio - Produtos Farmacêuticos Unipessoal, Lda. Largo Alexandre Herculano, 2 7050-110 Montemor-O-Novo Portugal

Ibuprofen Kifen 200 mg Dispersible tablet Oral use

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Portugal Angelini Farmacêutica, Lda. Rua João Chagas, 53 - 3º 1499-040 Cruz Quebrada - Dafundo Portugal

Ibuprofen Moment 200 200 mg Coated tablet Oral use

Portugal Laboratorio de Aplicaciones Farmacodinamicas, S.A. C/ Grassot, 16 08025 Barcelona Spain

Ibuprofen NORVECTAN 400 400 mg Powder for oral suspension

Oral use

Portugal Laboratorio de Aplicaciones Farmacodinamicas, S.A. C/ Grassot, 16 08025 Barcelona Spain

Ibuprofen NORVECTAN 600 600 mg Powder for oral suspension

Oral use

Portugal Distrifarma - Companhia de Distribuição Farmacêutica, S.A. Estrada Consiglieri Pedroso, 80 - Lt. 3 - Armz. 1/12 - Queluz de Baixo 2745-553 Barcarena Portugal

Ibuprofen Nolofene 200 mg Coated tablet Oral use

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Portugal Reckitt Benckiser Healthcare, Lda. Rua D. Cristovão da Gama, 1 - 1º C/D 1400-113 Lisboa Portugal

Ibuprofen Nurofen 40 mg/ml Oral suspension Oral use

Portugal Reckitt Benckiser Healthcare, Lda. Rua D. Cristovão da Gama, 1 - 1º C/D 1400-113 Lisboa Portugal

Ibuprofen Nurofen 200 mg Coated tablet Oral use

Portugal Reckitt Benckiser Healthcare, Lda. Rua D. Cristovão da Gama, 1 - 1º C/D 1400-113 Lisboa Portugal

Ibuprofen Nurofen 200 mg Capsule, soft Oral use

Portugal Reckitt Benckiser Healthcare, Lda. Rua D. Cristovão da Gama, 1 - 1º C/D 1400-113 Lisboa Portugal

Ibuprofen Nurofen 400 400 mg Coated tablet Oral use

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Portugal Reckitt Benckiser Healthcare, Lda. Rua D. Cristovão da Gama, 1 - 1º C/D 1400-113 Lisboa Portugal

Ibuprofen Nurofen Della 400 mg Coated tablet Oral use

Portugal Reckitt Benckiser Healthcare, Lda. Rua D. Cristovão da Gama, 1 - 1º C/D 1400-113 Lisboa Portugal

Ibuprofen Nurofen Zavance 400 mg Capsule, soft Oral use

Portugal Reckitt Benckiser Healthcare, Lda. Rua D. Cristovão da Gama, 1 - 1º C/D 1400-113 Lisboa Portugal

Ibuprofen Nurofen Zavance 200 mg Coated tablet Oral use

Portugal Omega Pharma Portuguesa, Unipessoal, Lda. Av. Tomás Ribeiro 43, Edifício Neopark, Bloco 1 - 3ºC 2790-221 Carnaxide Portugal

Ibuprofen Ozonol 200 mg Coated tablet Oral use

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Portugal Laboratórios Azevedos - Indústria Farmacêutica, S.A. Edifícios Azevedos - Estrada Nacional 117-2, Alfragide 2614-504 Amadora Portugal

Ibuprofen Solufen 20 mg/ml Oral suspension Oral use

Portugal Laboratórios Azevedos - Indústria Farmacêutica, S.A. Edifícios Azevedos - Estrada Nacional 117-2, Alfragide 2614-504 Amadora Portugal

Ibuprofen Solufen 200 mg Capsule, hard Oral use

Portugal Zambon - Produtos Farmacêuticos, Lda. Rua Comandante Enrique Maya, 1 1500-192 Lisboa Portugal

Ibuprofen Spidifen 200 mg Granules for oral solution

Oral use

Portugal Zambon - Produtos Farmacêuticos, Lda. Rua Comandante Enrique Maya, 1 1500-192 Lisboa Portugal

Ibuprofen Spidifen 600 mg Granules for oral solution

Oral use

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Portugal Zambon - Produtos Farmacêuticos, Lda. Rua Comandante Enrique Maya, 1 1500-192 Lisboa Portugal

Ibuprofen Spidifen 400 mg Granules for oral solution

Oral use

Portugal Zambon - Produtos Farmacêuticos, Lda. Rua Comandante Enrique Maya, 1 1500-192 Lisboa Portugal

Ibuprofen Spidifen 400 mg Comprimidos

400 mg Film-coated tablet Oral use

Portugal Zambon - Produtos Farmacêuticos, Lda. Rua Comandante Enrique Maya, 1 1500-192 Lisboa Portugal

Ibuprofen Spidifen Limão 400 mg Granules for oral solution

Oral use

Portugal Generis Farmacêutica, S.A. Rua João de Deus, 19 2700-487 Amadora Portugal

Ibuprofen Tricalma 200 mg Coated tablet Oral use

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Portugal Laboratório Medinfar - Produtos Farmacêuticos, S.A. Rua Manuel Ribeiro de Pavia, 1 - 1º - Venda Nova 2700-547 Amadora Portugal

Ibuprofen Trifene 20 mg/ml Oral suspension Oral use

Portugal Medinfar Consumer Health - Produtos Farmacêuticos, Lda. Rua Henrique Paiva Couceiro, 27 - Venda Nova 2700-451 Amadora Portugal

Ibuprofen Trifene 200 200 mg Film-coated tablet Oral use

Portugal Laboratório Medinfar - Produtos Farmacêuticos, S.A. Rua Manuel Ribeiro de Pavia, 1 - 1º - Venda Nova 2700-547 Amadora Portugal

Ibuprofen Trifene 400 400 mg Coated tablet Oral use

Portugal Laboratório Medinfar - Produtos Farmacêuticos, S.A. Rua Manuel Ribeiro de Pavia, 1 - 1º - Venda Nova 2700-547 Amadora Portugal

Ibuprofen Trifene 400 400 mg Film-coated tablet Oral use

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INN Invented name Strength Pharmaceutical form

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Portugal Laboratório Medinfar - Produtos Farmacêuticos, S.A. Rua Manuel Ribeiro de Pavia, 1 - 1º - Venda Nova 2700-547 Amadora Portugal

Ibuprofen Trifene 600 600 mg Coated tablet Oral use

Portugal Medinfar Consumer Health - Produtos Farmacêuticos, Lda. Rua Henrique Paiva Couceiro, 27 - Venda Nova 2700-451 Amadora Portugal

Ibuprofen Trifene Dispersível 200 mg Dispersible tablet Oral use

Portugal Laboratório Medinfar - Produtos Farmacêuticos, S.A. Rua Manuel Ribeiro de Pavia, 1 - 1º - Venda Nova 2700-547 Amadora Portugal

Ibuprofen Trifene Efervescente 200 mg Effervescent tablet Oral use

Portugal Labialfarma - Laboratório de Produtos Farmacêuticos e Nutracêuticos, S.A. Edifício Labialfarma, 1 - Felgueira 3450-336 Sobral - Mortágua Portugal

Ibuprofen Zip-A-Dol 200 mg Capsule, hard Oral use

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Portugal Jaba Recordati, S. A. Lagoas Park, Edificio 5, Torre C, Piso 3 2740-298 Porto Salvo Portugal

Dexibuprofen Seractil 200 mg Film-coated tablet Oral use

Portugal Jaba Recordati, S. A. Lagoas Park, Edificio 5, Torre C, Piso 3 2740-298 Porto Salvo Portugal

Dexibuprofen Seractil 300 mg Film-coated tablet Oral use

Portugal Jaba Recordati, S. A. Lagoas Park, Edificio 5, Torre C, Piso 3 2740-298 Porto Salvo Portugal

Dexibuprofen Seractil 400 mg Film-coated tablet Oral use

Romania Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

IBUPROFEN ADAGIN 200 mg 200 mg Film-coated tablet Oral use

Romania Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

IBUPROFEN ADAGIN 400 mg 400 mg Film-coated tablet Oral use

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Romania Pfizer Corporation Austria GmbH Floridsdorfer Hauptstraße 1 1210 Wien Austria

IBUPROFEN ADVIL 200 mg Coated tablet Oral use

Romania Pfizer Corporation Austria GmbH Floridsdorfer Hauptstraße 1 1210 Wien Austria

IBUPROFEN ADVIL ULTRA 400 mg Capsule, soft Oral use

Romania Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

IBUPROFEN ALGIN BABY 100 mg/5 ml

20 mg/ml Oral suspension Oral use

Romania Abbott Scandinavia AB P.O Box 1498 SE-171 29 Solna Sweden

IBUPROFEN BRUFEN 20 mg/ml 20 mg/ml Oral suspension Oral use

Romania Abbott Scandinavia AB P.O Box 1498 SE-171 29 Solna Sweden

IBUPROFEN BRUFEN 400 mg 400 mg Film-coated tablet Oral use

Romania Abbott Scandinavia AB P.O Box 1498 SE-171 29 Solna Sweden

IBUPROFEN BRUFEN 400 mg 400 mg Effervescent granules Oral use

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INN Invented name Strength Pharmaceutical form

Route of administration

Romania Abbott Scandinavia AB P.O Box 1498 SE-171 29 Solna Sweden

IBUPROFEN BRUFEN RETARD 800 mg

800 mg Prolonged-release tablet

Oral use

Romania S.C. SOLACIUM PHARMA S.R.L. Calea Rahovei nr. 266-268, corp 63, anexele B-C, stâlpii 3-4, etaj 3, cam. 10, sector 5, București Romania

IBUPROFEN EFISEN M 200 mg 200 mg Film-coated tablet Oral use

Romania Zambon S.p.A. Via Lillo del Duca 10 20091, Bresso (Mi) Italy

IBUPROFEN FASPIC 400 mg 400 mg Granules for oral solution

Oral use

Romania Zambon S.p.A. Via Lillo del Duca 10 20091, Bresso (Mi) Italy

IBUPROFEN FASPIC 600 600 mg Granules for oral solution

Oral use

Romania Zambon S.p.A. Via Lillo del Duca 10 20091, Bresso (Mi) Italy

IBUPROFEN FASPIC® 400 mg 400 mg Film-coated tablet Oral use

Romania Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

IBUPROFEN IBALGIN 200 mg Film-coated tablet Oral use

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INN Invented name Strength Pharmaceutical form

Route of administration

Romania Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

IBUPROFEN IBALGIN FORTE 400 mg Film-coated tablet Oral use

Romania Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

IBUPROFEN IBALGIN FORTE 400 mg Film-coated tablet Oral use

Romania Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

IBUPROFEN IBALGIN RAPID 400 mg Film-coated tablet Oral use

Romania S.C. ANTIBIOTICE S.A. Str. Valea Lupului nr.1, Iaşi Romania

IBUPROFEN IBUFEN 200 mg 200 mg Film-coated tablet Oral use

Romania S.C. ARENA GROUP S.A. Str. Ştefan Mihăileanu nr.31, Sector 2, Bucureşti, România

IBUPROFEN IBUPROFEN ARENA 200 mg

200 mg Capsule, hard Oral use

Romania S.C. ARENA GROUP S.A. Str. Ştefan Mihăileanu nr.31, Sector 2, Bucureşti, România

IBUPROFEN IBUPROFEN ARENA 400 mg

400 mg Capsule, hard Oral use

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Romania CIPLA (UK) LIMITED The Old Post House Heath Road, Surrey Weybridge KT13 8TS United Kingdom

IBUPROFEN IBUPROFEN CIPLA 200 200 mg Film-coated tablet Oral use

Romania CIPLA (UK) LIMITED The Old Post House Heath Road, Surrey Weybridge KT13 8TS United Kingdom

IBUPROFEN IBUPROFEN CIPLA 400 400 mg Film-coated tablet Oral use

Romania CIPLA (UK) LIMITED The Old Post House Heath Road, Surrey Weybridge KT13 8TS United Kingdom

IBUPROFEN IBUPROFEN CIPLA 600 600 mg Film-coated tablet Oral use

Romania Abbott Scandinavia AB P.O Box 1498 SE-171 29 Solna Sweden

IBUPROFEN ABFEN 200 mg/5 ml suspensie orală

40 mg/ml Oral suspension Oral use

Romania Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany

IBUPROFEN MIG 40 mg/ ml 40 mg/ml Oral suspension Oral use

Romania Abbott Scandinavia AB P.O Box 1498 SE-171 29 Solna Sweden

IBUPROFEN ABFEN 200 mg 200 mg Effervescent granules Oral use

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Romania Abbott Scandinavia AB P.O Box 1498 SE-171 29 Solna Sweden

IBUPROFEN BRUFEN 600 mg 600 mg Effervescent granules Oral use

Romania S.C. Sandoz S.R.L. Str. Livezeni, Nr. 7A 540472 Târgu Mureş Romania

IBUPROFEN IBUPROFEN SANDOZ 20 mg/ml

20 mg/ml Oral suspension Oral use

Romania S.C. Sandoz S.R.L. Str. Livezeni, Nr. 7A 540472 Târgu Mureş Romania

IBUPROFEN IBUPROFEN SANDOZ 40 mg/ml

40 mg/ml Oral suspension Oral use

Romania US Pharmacia Sp. z o.o. Ziebicka st. 40 50-507 Wroclaw Poalnd

IBUPROFEN IBUPROM 200 mg Coated tablet Oral use

Romania Alvogen IPCo S.àr.l. Rue Heienhaff, 5 L-1736, Senningerberg Luxemburg

IBUPROFEN INFLANOR 200 mg 200 mg Capsule, soft Oral use

Romania Alvogen IPCo S.àr.l. Rue Heienhaff, 5 L-1736, Senningerberg Luxemburg

IBUPROFEN INFLANOR FORTE 400 mg

400 mg Capsule, soft Oral use

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INN Invented name Strength Pharmaceutical form

Route of administration

Romania S.C. LAROPHARM S.R.L. Şoseaua Alexandriei nr. 145 A, Bragadiru, Ilfov Romania

IBUPROFEN LAROFEN 200 mg 200 mg Film-coated tablet Oral use

Romania GLAXOSMITHKLINE CONSUMER HEALTHCARE S.R.L. Str. Costache Negri, Nr. 1-5 Opera Center One Etaj 6 (Zona 2), Sector 5 Bucureşti România

IBUPROFEN PANAFEN 200 mg 200 mg Capsule, hard Oral use

Romania GLAXOSMITHKLINE CONSUMER HEALTHCARE S.R.L. Str. Costache Negri, Nr. 1-5 Opera Center One Etaj 6 (Zona 2), Sector 5 Bucureşti România

IBUPROFEN PANAFEN 400 mg 400 mg Capsule, hard Oral use

Romania Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany

IBUPROFEN MIG-400 400 mg Film-coated tablet Oral use

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INN Invented name Strength Pharmaceutical form

Route of administration

Romania Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

IBUPROFEN NUROFEN EXPRESS 200 mg

200 mg Capsule, soft Oral use

Romania Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

IBUPROFEN NUROFEN EXPRESS 200 mg

200 mg Capsule, soft Oral use

Romania Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

IBUPROFEN NUROFEN EXPRESS 400 mg

400 mg Oral powder Oral use

Romania Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

IBUPROFEN NUROFEN EXPRESS FORTE 400 mg

400 mg Capsule, soft Oral use

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INN Invented name Strength Pharmaceutical form

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Romania Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

IBUPROFEN NUROFEN FORTE 400 mg Capsule, hard Oral use

Romania Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

IBUPROFEN NUROFEN IMMEDIA ULTRA 400 mg

400 mg Capsule, hard Oral use

Romania Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

IBUPROFEN NUROFEN® 200 mg 200 mg Capsule, hard Oral use

Romania US Pharmacia Sp. z o.o. Ziebicka st. 40 50-507 Wroclaw Poalnd

IBUPROFEN PADUDEN FORTE 400 mg

400 mg Capsule, hard Oral use

Romania S.C. TERAPIA S.A. Str. Fabricii, nr. 124 Cluj-Napoca Romania

IBUPROFEN PADUDEN® 200 mg 200 mg Capsule, hard Oral use

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INN Invented name Strength Pharmaceutical form

Route of administration

Romania S.C. TERAPIA S.A. Str. Fabricii, nr. 124 Cluj-Napoca Romania

IBUPROFEN PADUDEN® SR 300 mg 300 mg Prolonged-release capsule, hard

Oral use

Romania S.C. AC HELCOR S.R.L. Str. Dr.Victor Babeş Nr. 50 Baia Mare Romania

IBUPROFEN REUPROFEN 200 mg 200 mg Film-coated tablet Oral use

Romania S.C. AC HELCOR S.R.L. Str. Dr.Victor Babeş Nr. 50 Baia Mare Romania

IBUPROFEN REUPROFEN 400 mg 400 mg Film-coated tablet Oral use

Romania Medochemie Ltd 1-10 Constantinoupoleos str Limassol 3505 Cyprus

IBUPROFEN RUPAN 200 mg 200 mg Film-coated tablet Oral use

Romania Bayer S.R.L. Şos. Pipera Nr. 42, Etajele 1, 16, 17 Sector 2, Bucureşti Romania

IBUPROFEN SARIDON N 400 400 mg Film-coated tablet Oral use

Romania Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Ibuprofen pseudoephedrine

MODAFEN 200 mg 30 mg

Film-coated tablet Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Romania US Pharmacia Sp. z o.o. Ziebicka st. 40 50-507 Wroclaw Poalnd

Ibuprofen pseudoephedrine

IBUPROM SINUS 200 mg/30 mg

200 mg 30 mg

Coated tablet Oral use

Romania Boehringer Ingelheim International GmbH Binger Straße 173 55216 Ingelheim am Rhein Germany

Ibuprofen pseudoephedrine

MUCOGRIP 200 mg/30 mg

200 mg 30 mg

Film-coated tablet Oral use

Romania Abbott Scandinavia AB P.O Box 1498 SE-171 29 Solna Sweden

Ibuprofen pseudoephedrine

BRUFEN PLUS 400 mg/30 mg

Film-coated tablet Oral use

Slovak Republic

Pfizer Corporation Austria GmbH Floridsdorfer Hauptstraße 1 1210 Wien Austria

Ibuprofen ADVIL RAPID 400 mg Capsule, soft Oral use

Slovak Republic

BGP Products s.r.o. Karadžičova 10 821 08 Bratislava Slovakia

Ibuprofen Brufen 400 400 mg Film-coated tablet Oral use

Slovak Republic

BGP Products s.r.o. Karadžičova 10 821 08 Bratislava Slovakia

Ibuprofen Brufedol 400 mg šumivý granulát

400 mg Effervescent granules Oral use

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INN Invented name Strength Pharmaceutical form

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Slovak Republic

BGP Products s.r.o. Karadžičova 10 821 08 Bratislava Slovakia

Ibuprofen Brufen 600 600 mg Effervescent granules Oral use

Slovak Republic

BGP Products s.r.o. Karadžičova 10 821 08 Bratislava Slovakia

Ibuprofen Brufen retard 800 800 mg Film-coated prolonged-release tablet

Oral use

Slovak Republic

BGP Products s.r.o. Karadžičova 10 821 08 Bratislava Slovakia

Ibuprofen BRUFEN sirup 20 mg/ml Syrup Oral use

Slovak Republic

Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Ibuprofen Ibalgin 200 200 mg Film-coated tablet Oral use

Slovak Republic

Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Ibuprofen Ibalgin 400 400 mg Film-coated tablet Oral use

Slovak Republic

Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Ibuprofen Ibalgin 600 600 mg Film-coated tablet Oral use

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INN Invented name Strength Pharmaceutical form

Route of administration

Slovak Republic

Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Ibuprofen IBALGIN FAST 400 mg Film-coated tablet Oral use

Slovak Republic

Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Ibuprofen phenylephrine

Ibalgin Grip 200 mg/5 mg

Film-coated tablet Oral use

Slovak Republic

Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Ibudolor 200 mg 200 mg Film-coated tablet Oral use

Slovak Republic

Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Ibudolor 400 mg 400 mg Film-coated tablet Oral use

Slovak Republic

Generics UK Albany Gate Darkes Lane Potters Bar Hertfordshire EN6 1AG United Kingdom

Ibuprofen Ibumyl Rapid 200 mg 200 mg Film-coated tablet Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Slovak Republic

Generics UK Albany Gate Darkes Lane Potters Bar Hertfordshire EN6 1AG United Kingdom

Ibuprofen Ibumyl Rapid 400 mg 400 mg Film-coated tablet Oral use

Slovak Republic

STADA Arzneimittel AG Stadastr. 2-18 61118 Bad Vilbel Germany

Ibuprofen Ibuprofen 400 STADA 400 mg Film-coated tablet Oral use

Slovak Republic

Dr. Max Pharma Ltd. First Floor Roxburge House, Regent Street 273-287 W1B 2HA London United Kingdom

Ibuprofen Ibuprofen Dr.Max 200 mg filmom obalené tablety

200 mg Film-coated tablet Oral use

Slovak Republic

Dr. Max Pharma Ltd. First Floor Roxburge House, Regent Street 273-287 W1B 2HA London United Kingdom

Ibuprofen Ibuprofen Dr.Max 400 mg filmom obalené tablety

400 mg Film-coated tablet Oral use

Slovak Republic

Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

Ibuprofen Ibuprofen Galpharm 200 mg obalené tablety

200 mg Coated tablet Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Slovak Republic

Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

Ibuprofen Ibuprofen Galpharm 400 mg obalené tablety

400 mg Coated tablet Oral use

Slovak Republic

BGP Products s.r.o. Karadžičova 10 821 08 Bratislava Slovakia

Ibuprofen Brufedol 200 mg šumivý granulát

200 mg Effervescent granules Oral use

Slovak Republic

Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibuprofen Ibutabs 200 mg 200 mg Film-coated tablet Oral use

Slovak Republic

Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibuprofen Ibutabs 400 mg 400 mg Film-coated tablet Oral use

Slovak Republic

Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibuprofen Ibutabs 600 mg 600 mg Film-coated tablet Oral use

Slovak Republic

Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibuprofen Ibutabs 800 mg 800 mg Film-coated tablet Oral use

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INN Invented name Strength Pharmaceutical form

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Slovak Republic

Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany

Ibuprofen MIG-400 400 mg Film-coated tablet Oral use

Slovak Republic

Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Ibuprofen pseudoephedrine

MODAFEN 200 mg Film-coated tablet Oral use

Slovak Republic

Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Ibuprofen NUROFEN 200 mg 200 mg Coated tablet Oral use

Slovak Republic

Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Ibuprofen NUROFEN 400 mg 400 mg Coated tablet Oral use

Slovak Republic

Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Ibuprofen Nurofen Expres 200 mg 200 mg Coated tablet Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Slovak Republic

Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Ibuprofen Nurofen Expres 400 mg 400 mg Coated tablet Oral use

Slovak Republic

Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Ibuprofen Nurofen Instant 400 mg perorálny prášok

400 mg Oral powder Oral use

Slovak Republic

Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Ibuprofen Nurofen Rapid 200 mg Capsules

200 mg Capsule, soft Oral use

Slovak Republic

Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Ibuprofen NUROFEN Rapid 400 mg Capsules

400 mg Capsule, soft Oral use

258

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Slovak Republic

Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Ibuprofen pseudoephedrine

NUROFEN STOPGRIP 200 mg Film-coated tablet Oral use

Slovenia KRKA d.d Šmarješka cesta 6 8000 Novo mesto Slovenia

Ibuprofen Bonifen 200 mg filmsko obložene tablete

200 mg Film-coated tablet Oral use

Slovenia Abbott Laboratories d.o.o. Dolenjska cesta 242c 1000 Ljubljana Slovenia

Ibuprofen Brufen 20 mg/ml peroralna suspenzija

20 mg/ml Oral suspension Oral use

Slovenia Abbott Laboratories d.o.o. Dolenjska cesta 242c 1000 Ljubljana Slovenia

Ibuprofen Brufen 200 mg filmsko obložene tablete

200 mg Film-coated tablet Oral use

Slovenia Abbott Laboratories d.o.o. Dolenjska cesta 242c 1000 Ljubljana Slovenia

Ibuprofen Brufen 400 mg filmsko obložene tablete

400 mg Film-coated tablet Oral use

Slovenia Abbott Laboratories d.o.o. Dolenjska cesta 242c 1000 Ljubljana Slovenia

Ibuprofen Brufen 400 mg šumeča zrnca

400 mg Effervescent granules Oral use

259

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Slovenia Abbott Laboratories d.o.o. Dolenjska cesta 242c 1000 Ljubljana Slovenia

Ibuprofen Brufen 600 mg filmsko obložene tablete

600 mg Film-coated tablet Oral use

Slovenia Abbott Laboratories d.o.o. Dolenjska cesta 242c 1000 Ljubljana Slovenia

Ibuprofen Brufen retard 800 mg tablete s podaljšanim sproščanjem

800 mg Prolonged-release tablet

Oral use

Slovenia Abbott Laboratories d.o.o. Dolenjska cesta 242c 1000 Ljubljana Slovenia

Ibuprofen Brufen z okusom jagode 40 mg/ml peroralna suspenzija

40 mg/ml Oral suspension Oral use

Slovenia LEK d.d. Verovškova 57 1526 Ljubljana Slovenia

Ibuprofen Diverin 400 mg filmsko obložene tablete

400 mg Film-coated tablet Oral use

Slovenia LEK d.d. Verovškova 57 1526 Ljubljana Slovenia

Ibuprofen Diverin za otroke 40 mg/ml peroralna suspenzija z okusom jagode

40 mg/ml Oral suspension Oral use

Slovenia Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibuprofen Ibacut 200 mg filmsko obložene tablete

200 mg Film-coated tablet Oral use

Slovenia Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibuprofen Ibacut 400 mg filmsko obložene tablete

400 mg Film-coated tablet Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Slovenia sanofi-aventis d.o.o. Dunajska cesta 151 1000 Ljubljana Slovenia

Ibuprofen Ibalgin NEO 400 mg filmsko obložene tablete

400 mg Film-coated tablet Oral use

Slovenia Belupo, d.o.o. Dvoržakova 6 1000 Ljubljana Slovenia

Ibuprofen Ibubel 200 mg filmsko obložene tablete

200 mg Film-coated tablet Oral use

Slovenia Belupo, d.o.o. Dvoržakova 6 1000 Ljubljana Slovenia

Ibuprofen Ibubel 400 mg filmsko obložene tablete

400 mg Film-coated tablet Oral use

Slovenia Belupo, d.o.o. Dvoržakova 6 1000 Ljubljana Slovenia

Ibuprofen Ibuprofen Belupo 20 mg/ml peroralna suspenzija

20 mg/ml Oral suspension Oral use

Slovenia Belupo, d.o.o. Dvoržakova 6 1000 Ljubljana Slovenia

Ibuprofen IBUPROFEN BELUPO 400 mg filmsko obložene tablete

400 mg Film-coated tablet Oral use

Slovenia Belupo, d.o.o. Dvoržakova 6 1000 Ljubljana Slovenia

Ibuprofen IBUPROFEN BELUPO 600 mg filmsko obložene tablete

600 mg Film-coated tablet Oral use

Slovenia Belupo, d.o.o. Dvoržakova 6 1000 Ljubljana Slovenia

Ibuprofen IBUPROFEN BELUPO 800 mg filmsko obložene tablete

800 mg Film-coated tablet Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Slovenia Abbott Laboratories d.o.o. Dolenjska cesta 242c 1000 Ljubljana Slovenia

Ibuprofen Brufen Gran 200 mg šumeča zrnca

200 mg Effervescent granules Oral use

Slovenia Abbott Laboratories d.o.o. Dolenjska cesta 242c 1000 Ljubljana Slovenia

Ibuprofen Brufen 600 mg šumeča zrnca

600 mg Effervescent granules Oral use

Slovenia Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibuprofen Ibuprofen Vitabalans 200 mg filmsko obložene tablete

200 mg Film-coated tablet Oral use

Slovenia Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibuprofen Ibuprofen Vitabalans 400 mg filmsko obložene tablete

400 mg Film-coated tablet Oral use

Slovenia Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibuprofen Ibuprofen Vitabalans 600 mg filmsko obložene tablete

600 mg Film-coated tablet Oral use

Slovenia Vitabalans Oy Varastokatu 8 13500 Hämeenlinna Finland

Ibuprofen Ibuprofen Vitabalans 800 mg filmsko obložene tablete

800 mg Film-coated tablet Oral use

262

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Slovenia Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Ibuprofen Nurofen 200 mg obložene tablete

200 mg Film-coated tablet Oral use

Slovenia Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire SL1 3UH Slough United Kingdom

Ibuprofen Nurofen Immedia 200 mg mehke kapsule

200 mg Capsule, soft Oral use

Spain ISDIN, S.A. Provençals, 33 08019 Barcelona Spain

Ibuprofen ALGIASDIN 600 mg comprimidos recubiertos con película

600 mg Film-coated tablet Oral use

Spain ISDIN, S.A. Provençals, 33 08019 Barcelona Spain

Ibuprofen ALGIASDIN RETARD 600 mg comprimidos recubiertos de liberación prolongada

600 mg Coated tablet Oral use

Spain Abbott Laboratories, S.A. Avda. de Burgos, 91 28050 Madrid Spain

Ibuprofen DALSY 400 mg comprimidos recubiertos con película

400 mg Film-coated tablet Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Spain Johnson and Johnson, S.A. Pº de las 12 Estrellas, 5-7 Campo de las Naciones 28042 Madrid Spain

Ibuprofen DOCTRIL 400 FORTE BLISTER

400 mg Coated tablet Oral use

Spain ZAMBON, S.A. Maresme, 5 Polígono Can Bernardes-Subirá 08130 Sta. Perpetua de la Mogoda (Barcelona) Spain

Ibuprofen ESPIDIDOL 400 mg comprimidos recubiertos

400 mg Coated tablet Oral use

Spain ZAMBON, S.A. Maresme, 5 Polígono Can Bernardes-Subirá 08130 Sta. Perpetua de la Mogoda (Barcelona) Spain

Ibuprofen arginine ESPIDIFEN 400 mg comprimidos recubiertos

400 mg Coated tablet Oral use

Spain Ferrer Internacional, S.A. Gran Vía Carlos III, 94 08028 Barcelona Spain

Ibuprofen GELOFENO 200 mg comprimidos

200 mg Tablet Oral use

Spain Ferrer Internacional, S.A. Gran Vía Carlos III, 94 08028 Barcelona Spain

Ibuprofen GELOFENO 400 mg comprimidos

400 mg Tablet Oral use

264

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Spain Ferrer Internacional, S.A. Gran Vía Carlos III, 94 08028 Barcelona Spain

Ibuprofen GELOFENO 600 mg comprimidos

400 mg Tablet Oral use

Spain LABORATORIOS CINFA, S.A. Olaz-Chipi, 10 Polígono Industrial Areta 31620 Huarte-Pamplona (Navarra) Spain

Ibuprofen IBUFEN 400 mg comprimidos recubiertos con película

400 mg Film-coated tablet Oral use

Spain TEVA PHARMA, S.L.U. Anabel Segura, 11 Edificio Albatros B, 1ª planta 28108 Alcobendas (Madrid) Spain

Ibuprofen IBUMAC 600 mg comprimidos

600 mg Film-coated tablet Oral use

Spain KERN PHARMA, S.L. Venus, 72. Poligono Industrial Colon II. Tarrasa (Barcelona) 08228 Spain

Ibuprofen IBUKERN 400 mg comprimidos recubiertos con película EFG

400 mg Film-coated tablet Oral use

Spain KERN PHARMA, S.L. Venus, 72. Poligono Industrial Colon II. Tarrasa (Barcelona) 08228 Spain

Ibuprofen IBUKERN 600 mg comprimidos recubiertos con película EFG

600 mg Film-coated tablet Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Spain Bexal Farmaceutica, S.A. Centro Empresarial Osa Mayor Avda. Osa Mayor, 4 - Area B 28023 Aravaca (Madrid) Spain

Ibuprofen IBUPROFENO ACOST 600 mg comprimidos recubiertos con película EFG

600 mg Film-coated tablet Oral use

Spain Aurovitas Spain, S.A.U. Avda. de Burgos, 16-D 28036 Madrid Spain

Ibuprofen IBUPROFENO ACTAVIS 600 mg comprimidos recubiertos con película EFG

600 mg Film-coated tablet Oral use

Spain ALMUS FARMACEUTICA, S.A. Avda. Verge de Montserrat, 6 08820 El Prat de Llobregat (Barcelona) Spain

Ibuprofen IBUPROFENO ALMUS 600 mg comprimidos recubiertos con película EFG

600 mg Film-coated tablet Oral use

Spain APOTEX EUROPE B.V Darwinweb, 20 2333-CR Leiden Netherlands

Ibuprofen IBUPROFENO APOTEX 600 mg comprimidos recubiertos con película EFG

600 mg Film-coated tablet Oral use

Spain LABORATORIOS COMBIX, S.L.U. Badajoz, 2, Edificio 2 28223 Pozuelo de Alarcón (Madrid) Spain

Ibuprofen IBUPROFENO PHARMA COMBIX 600 mg comprimidos recubiertos con película EFG

600 mg Film-coated tablet Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Spain LABORATORIOS CINFA, S.A. Olaz-Chipi, 10 Polígono Industrial Areta 31620 Huarte-Pamplona (Navarra) Spain

Ibuprofen IBUPROFENO CINFA 600 mg comprimidos recubiertos con película EFG

600 mg Film-coated tablet Oral use

Spain GENERICOS, S.L. Frederic Mompou, 5 08960 Sant Just Desvern (Barcelona) Spain

Ibuprofen IBUPROFENO STADA GENÉRICOS 400 mg comprimidos recubiertos con película EFG

400 mg Film-coated tablet Oral use

Spain LABORATORIOS COMBIX, S.L.U. Badajoz, 2, Edificio 2 28223 Pozuelo de Alarcón (Madrid) Spain

Ibuprofen IBUPROFENO COMBIX 600 mg comprimidos recubiertos con película EFG

600 mg Film-coated tablet Oral use

Spain LABORATORIOS DAVUR, S.L. Teide, 4-planta baja. Poligono Empresarial La Marina, San Sebastián de los Reyes (Madrid) 28703 Spain

Ibuprofen IBUPROFENO DAVUR 600 mg comprimidos recubiertos con película EFG

600 mg Film-coated tablet Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Spain DERMOGEN FARMA, S.A. San Rafael, 3 28108 Alcobendas (Madrid) Spain

Ibuprofen IBUPROFENO DERMOGEN 400 mg comprimidos recubiertos

400 mg Film-coated tablet Oral use

Spain DERMOGEN FARMA, S.A. San Rafael, 3 28108 Alcobendas (Madrid) Spain

Ibuprofen IBUPROFENO DERMOGENERIS 400 mg comprimidos recubiertos con película EFG

400 mg Film-coated tablet Oral use

Spain LABORATORIOS FRANCISCO DURBAN, S.A. Calle IX nº 75-76 Polígono Industrial La Redonda 04710 El Ejido (Almería) Spain

Ibuprofen IBUPROFENO DURBAN 400 mg comprimidos

400 mg Tablet Oral use

Spain MABO-FARMA, S.A. Carretera M-300 Km 30,500 28802 Alcalá de Henares (Madrid) Spain

Ibuprofen IBUPROFENO ABDRUG 600 m comprimidos recubiertos con película EFG

600 mg Film-coated tablet Oral use

Spain Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofen IBUPROFENO LIDERFARM 600 mg comprimidos recubiertos con película EFG

400 mg Film-coated tablet Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Spain STADA GENÉRICOS, S.L. Frederic Mompou, 5 08960 Sant Just Desvern (Barcelona) Spain

Ibuprofen IBUPROFENO STADA GENÉRICOS 600 mg comprimidos recubiertos con película EFG

600 mg Film-coated tablet Oral use

Spain LABORATORIOS ALTER, S.A. Mateo Inurria, 30 28036 Madrid Spain

Ibuprofen IBUPROFENO FARMALTER 600 mg comprimidos recubiertos con película EFG

600 mg Film-coated tablet Oral use

Spain LABORATORIOS GAYOSO, S.L. Hierro, 79 28850 Torrejón de Árdoz (Madrid) Spain

Ibuprofen IBUPROFENO GAYOSO 400 mg comprimidos bucodispersables

400 mg Orodispersible tablet Oral use

Spain Genericos Juventus Limited Julian Camarillo, 37 28037 Madrid Spain

Ibuprofen IBUPROFENO GENÉRICOS JUVENTUS 600 mg comprimidos recubiertos con película EFG

600 mg Film-coated tablet Oral use

Spain LABORATORIOS CINFA, S.A. Olaz-Chipi, 10 Polígono Industrial Areta 31620 Huarte-Pamplona (Navarra) Spain

Ibuprofen IBUPROFENO GOIBELA 600 mg comprimidos recubiertos con película EFG

600 mg Film-coated tablet Oral use

269

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Spain KERN PHARMA, S.L. Venus, 72. Poligono Industrial Colon II. Tarrasa (Barcelona) 08228 Spain

Ibuprofen IBUPROFENO KERN PHARMA 400 mg comprimidos EFG

400 mg Coated tablet Oral use

Spain KERN PHARMA, S.L. Venus, 72. Poligono Industrial Colon II. Tarrasa (Barcelona) 08228 Spain

Ibuprofen IBUPROFENO KERN PHARMA 600 mg comprimidos EFG

600 mg Coated tablet Oral use

Spain Korhispana, S.L. Carretera de Castellvell, 24 43206 Reus (Tarragona) Spain

Ibuprofen IBUPROFENO KORHISPANA 600 mg comprimidos recubiertos con película EFG

600 mg Film-coated tablet Oral use

Spain LABORATORIOS LLORENS, S.A Ciudad de Balaguer, 7-11 08022 Barcelona Spain

Ibuprofen IBUPROFENO LLORENS 600 mg comprimdos recubiertos EFG

600 mg Film-coated tablet Oral use

Spain MABO FARMA, S.A. Carretera M-300, Km. 30,500 28802 Alcalá de Henares (Madrid) Spain

Ibuprofen IBUPROFENO MABO 600 mg comprimidos recubiertos con película EFG

600 mg Film-coated tablet Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Spain MYLAN PHARMACEUTICALS, S.L. Plom 2-4, 5º planta 08038 Barcelona Spain

Ibuprofen IBUPROFENO MYLAN 600 mg comprimdos recubiertos EFG

600 MG Coated tablet Oral use

Spain MYLAN PHARMACEUTICALS, S.L. Plom 2-4, 5º planta 08038 Barcelona Spain

Ibuprofen IBUPROFENO MYLAN PHARMACEUTICALS 600 mg comprimidos recubiertos con película EFG

600 mg Film-coated tablet Oral use

Spain LABORATORIOS NORMON, S.A. Ronda de Valdecarrizo, 6 28760 Tres Cantos (Madrid) Spain

Ibuprofen IBUPROFENO NORMON 400 mg comprimidos recubiertos con película EFG

400 mg Film-coated tablet Oral use

Spain LABORATORIOS NORMON, S.A. Ronda de Valdecarrizo, 6 28760 Tres Cantos (Madrid) Spain

Ibuprofen IBUPROFENO NORMON 600 mg comprimidos recubiertos con película EFG

600 mg Film-coated tablet Oral use

Spain ONEDOSE PHARMA, S.L. Ca l'Alegre de Dalt, 28-30 08024 Barcelona Spain

Ibuprofen IBUPROFENO ONEDOSE 600 mg comprimidos recubiertos con película EFG

600 mg Film-coated tablet Oral use

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Spain LABORATORIOS CINFA, S.A. Olaz-Chipi, 10 Polígono Industrial Areta 31620 Huarte-Pamplona (Navarra) Spain

Ibuprofen IBUPROFENO OSODENT 600 mg comprimidos recubiertos con película EFG

600 mg Film-coated tablet Oral use

Spain PENSA PHARMA, S.A.U. Jorge Comín (médico pediatra), 3 46015 Valencia Spain

Ibuprofen IBUPROFENO PENSA 400 mg comprimidos recubiertos con película EFG

400 mg Film-coated tablet Oral use

Spain PENSA PHARMA, S.A.U. Jorge Comín (médico pediatra), 3 46015 Valencia Spain

Ibuprofen IBUPROFENO PENSA 600 mg comprimidos recubiertos con película EFG

600 mg Film-coated tablet Oral use

Spain PENSA PHARMA, S.A.U. Jorge Comín (médico pediatra), 3 46015 Valencia Spain

Ibuprofen IBUPROFENO PENSA PHARMA 600 mg comrpimidos recubiertos con película EFG

600 mg Film-coated tablet Oral use

Spain LABORATORIOS RANBAXY, S.L. Passeig de Gracia, 9 08007 Barcelona Spain

Ibuprofen IBUPROFENO RANBAXY 600 mg comprimidos recubiertos EFG

600 mg Coated tablet Oral use

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Spain RATIOPHARM ESPAÑA, S.A. Avda. de Burgos, 16 D-5ª planta 28036 Madrid Spain

Ibuprofen IBUPROFENO RATIOPHARM 600 mg comprimidos recubiertos con película EFG

600 mg Film-coated tablet Oral use

Spain SANDOZ FARMACÉUTICA, S.A. Avda. Osa Mayor 28023 Aravaca (Madrid) Spain

Ibuprofen IBUPROFENO SANDOZ 600 mg comprimidos recubiertos con película EFG

600 mg Film-coated tablet Oral use

Spain SMART PHARMA Andrés Mellado, 76 28015 Madrid Spain

Ibuprofen IBUPROFENO SMART 600 mg comprimidos recubiertos EFG

600 mg Coated tablet Oral use

Spain LABORATORIO STADA, S.A. Frederic Mompou, 5 08960 Sant Just Desvern (Barcelona) Spain

Ibuprofen IBUPROFENO STADA 600 mg comprimidos recubiertos con película EFG

600 mg Film-coated tablet Oral use

Spain STADA GENERICOS, S.L. Frederic Mompou, 5 08960 Sant Just Desvern (Barcelona) Spain

Ibuprofen IBUPROFENO STADAGEN 400 mg comprimidos recubiertos EFG

400 mg Coated tablet Oral use

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Spain STADA GENERICOS, S.L. Frederic Mompou, 5 08960 Sant Just Desvern (Barcelona) Spain

Ibuprofen IBUPROFENO STADAGEN 600 mg comprimidos recubiertos EFG

600 mg Coated tablet Oral use

Spain TARBIS FARMA, S.L. Gran Via Carlos III, 94 Barcelona, 08028 Spain

Ibuprofen IBUPROFENO TARBIS 600 mg comprimidos recubiertos con película EFG

600 mg Film-coated tablet Oral use

Spain TEVA PHARMA, S.L.U. Anabel Segura, 11 Edificio Albatros B, 1ª planta 28108 Alcobendas (Madrid) Spain

Ibuprofen IBUPROFENO TEVA 400 mg comprimidos recubiertos con película EFG

400 mg Film-coated tablet Oral use

Spain TEVA PHARMA, S.L.U. Anabel Segura, 11 Edificio Albatros B, 1ª planta 28108 Alcobendas (Madrid) Spain

Ibuprofen IBUPROFENO TEVA 600 mg comprimidos recubiertos con película EFG

600 mg Film-coated tablet Oral use

Spain Aristo Pharma Iberia, S.L. Solana, 26 28850 Torrejón de Ardoz (Madrid) Spain

Ibuprofen IBUPROFENO ARISTO 600 mg comprimidos recubiertos con película EFG

600 mg Film-coated tablet Oral use

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Spain Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Ibuprofen IBUPROFENO ZENTIVA 400 mg comprimidos recubiertos con película EFG

400 mg Film-coated tablet Oral use

Spain Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Ibuprofen IBUPROFENO ZENTIVA 600 mg comprimidos recubiertos con película EFG

600 mg Film-coated tablet Oral use

Spain Reckitt Benckiser Healthcare S.A. Mataró, 28. Granollers (Barcelona), 08403 Spain

Ibuprofen JUNIFEN 200 mg comprimidos bucodispersables sabor limón

200 mg Orodispersible tablet Oral use

Spain Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofen LIDERFEME 400 mg comprimidos

400 mg Film-coated tablet Oral use

Spain Abbott Laboratories, S.A. Avda. de Burgos, 91 28050 Madrid Spain

Ibuprofen NEOBRUFEN 400 mg comprimidos recubiertos con película EFG

400 mg Film-coated tablet Oral use

Spain Abbott Laboratories, S.A. Avda. de Burgos, 91 28050 Madrid Spain

Ibuprofen NEOBRUFEN 600 mg comprimidos recubiertos con película EFG

600 mg Film-coated tablet Oral use

275

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Spain Abbott Laboratories, S.A. Avda. de Burgos, 91 28050 Madrid Spain

Ibuprofen NEOBRUFEN RETARD 800 mg comprimidos de liberación prolongada

800 mg Coated tablet Oral use

Spain Reckitt Benckiser Healthcare S.A. Mataró, 28. Granollers (Barcelona), 08403 Spain

Ibuprofen sodium NUROFEN FAST (SODIO) 400 mg comprimidos recubiertos

400 mg Coated tablet Oral use

Spain Reckitt Benckiser Healthcare S.A. Mataró, 28. Granollers (Barcelona), 08403 Spain

Ibuprofen NUROFEN 400 mg comprimidos recubiertos

400 mg Film-coated tablet Oral use

Spain ASTREL PHARMA, S.L. Vía de las dos Castillas 9C, portal 2 -3ºC 28224 Madrid Spain

Ibuprofen IBUPROFENO ASTREL 400 mg comprimidos bucodispersables

400 mg Orodispersible tablet Oral use

Spain Angelini Farmaceutica, S.A. Osi 7-9 Barcelona 08034 Spain

Ibuprofen TODALGIL 400 mg comprimidos recubiertos con película

400 mg Film-coated tablet Oral use

276

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Spain ONEDOSE PHARMA, S.L. Ca l'Alegre de Dalt, 28-30 08024 Barcelona Spain

Ibuprofen UNODOL 400 mg comprimidos recubiertos con película EFG

400 mg Film-coated tablet Oral use

Spain LABORATORIOS ERN, S.A. Pedro IV, 499 Barcelona 08020 Spain

Ibuprofen APIROFENO 40 mg/ml SUSPENSION ORAL

40 mg/ml Oral suspension Oral use

Spain Angelini Farmaceutica, S.A. Osi 7-9 Barcelona 08034 Spain

Ibuprofen DADOSEL 20 mg/ml SUSPENSIÓN ORAL

20 mg/ml Oral suspension Oral use

Spain Abbott Laboratories, S.A. Avda. de Burgos, 91 28050 Madrid Spain

Ibuprofen DALSY 40 mg/ml SUSPENSION ORAL

40 mg/ml Oral suspension Oral use

Spain Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofen IBUFARMALID 200 mg SUSPENSION ORAL

200 mg Oral suspension Oral use

Spain Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofen IBUFARMALID 400 mg SUSPENSION ORAL

400 mg Oral suspension Oral use

Spain Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofen IBUFARMALID 600 mg SUSPENSION ORAL

600 mg Oral suspension Oral use

277

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INN Invented name Strength Pharmaceutical form

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Spain KERN PHARMA, S.L. Venus, 72. Poligono Industrial Colon II. Tarrasa (Barcelona) 08228 Spain

Ibuprofen IBUKERN 200 MG SUSPENSIÓN ORAL

200 mg Oral suspension Oral use

Spain KERN PHARMA, S.L. Venus, 72. Poligono Industrial Colon II. Tarrasa (Barcelona) 08228 Spain

Ibuprofen IBUKERN 400 MG SUSPENSION ORAL

400 mg Oral suspension Oral use

Spain KERN PHARMA, S.L. Venus, 72. Poligono Industrial Colon II. Tarrasa (Barcelona) 08228 Spain

Ibuprofen IBUKERN 600 MG SUSPENSION ORAL

600 mg Oral suspension Oral use

Spain Laboratorio Aldo Union, S.A. Baronesa de Malda, 73 Esplugues de Llobregat Barcelona 08950 Spain

Ibuprofen IBUPROFENO ALDO-UNIÓN 20 mg/ml SUSPENSIÓN ORAL EFG

20 mg/ml Oral suspension Oral use

Spain LABORATORIOS CINFA, S.A. Olaz-Chipi, 10 Polígono Industrial Areta 31620 Huarte-Pamplona (Navarra) Spain

Ibuprofen IBUPROFENO CINFA 100 mg/ 5 ml SUSPENSION ORAL EFG

20 mg/ml Oral suspension Oral use

278

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Spain LABORATORIOS CINFA, S.A. Olaz-Chipi, 10 Polígono Industrial Areta 31620 Huarte-Pamplona (Navarra) Spain

Ibuprofen IBUPROFENO CINFA 40 MG/ML SUSPENSION ORAL EFG

40 mg/ml Oral suspension Oral use

Spain Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofen IBUPROFENO CODRAMOL 20 mg / ml SUSPENSION ORAL EFG

20 mg/ml Oral suspension Oral use

Spain LABORATORIOS DAVUR, S.L. Teide, 4-planta baja. Poligono Empresarial La Marina, San Sebastián de los Reyes (Madrid) 28703 Spain

Ibuprofen IBUPROFENO DAVUR 20 mg/ ml SUSPENSIÓN ORAL EFG

20 mg/ml Oral suspension Oral use

Spain DERMOGEN FARMA, S.A. San Rafael, 3 28108 Alcobendas (Madrid) Spain

Ibuprofen IBUPROFENO DERMOGEN 400 mg SUSPENSION ORAL

400 mg Oral suspension Oral use

Spain Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofen IBUPROFENO FARMALID 20 mg/ml SUSPENSION ORAL EFG

20 mg/ml Oral suspension Oral use

279

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Spain FARMASIERRA LABORATORIOS, S.L. Ctra. Irún, km.26,200 San Sebastián de los Reyes (Madrid) 28700 Spain

Ibuprofen IBUPROFENO FARMASIERRA 20 mg/ml SUSPENSION ORAL

20 mg/ml Oral suspension Oral use

Spain KERN PHARMA, S.L. Venus, 72. Poligono Industrial Colon II. Tarrasa (Barcelona) 08228 Spain

Ibuprofen IBUPROFENO KERN PHARMA 40 MG/ML SUSPENSION ORAL EFG

40 mg/ml Oral suspension Oral use

Spain LABORATORIOS NORMON, S.A. Ronda de Valdecarrizo, 6 Tres Cantos (Madrid), 28670 Spain

Ibuprofen IBUPROFENO NORMON 40 mg/ml SUSPENSION ORAL EFG

40 mg/ml Oral suspension Oral use

Spain SANDOZ FARMACÉUTICA, S.A. Avda. Osa Mayor 28023 Aravaca (Madrid) Spain

Ibuprofen IBUPROFENO SANDOZ 100 mg/5 ml SUSPENSION ORAL

20 mg/ml Oral suspension Oral use

Spain SANDOZ FARMACÉUTICA, S.A. Avda. Osa Mayor 28023 Aravaca (Madrid) Spain

Ibuprofen IBUPROFENO SANDOZ 40 mg/ml SUSPENSION ORAL

40 mg/ml Oral suspension Oral use

280

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Spain Reckitt Benckiser Healthcare S.A. Mataró, 28. Granollers (Barcelona), 08403 Spain

Ibuprofen JUNIFEN 40 mg/ml SUSPENSION ORAL SABOR FRESA EFG

40 mg/ml Oral suspension Oral use

Spain DERMOGEN FARMA, S.A. San Rafael, 3 28108 Alcobendas (Madrid) Spain

Ibuprofen LEVEDOL 100 mg/5 ml SUSPENSION ORAL

20 mg/ml Oral suspension Oral use

Spain Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofen LIDERFEME 400 mg SUSPENSION ORAL

400 mg Oral suspension Oral use

Spain ITALFARMACO San Rafael, 3 28108 Alcobendas (Madrid) Spain

Ibuprofen IBLASIN 20mg/ml SUSPENSION ORAL

20 mg/ml Oral suspension Oral use

Spain ITALFARMACO San Rafael, 3 28108 Alcobendas (Madrid) Spain

Ibuprofen IBLASIN 40 mg/ml SUSPENSION ORAL

40 mg/ml Oral suspension Oral use

Spain Reckitt Benckiser Healthcare S.A. Mataró, 28. Granollers (Barcelona), 08403 Spain

Ibuprofen NUROFEN 40 MG/ML SUSPENSION ORAL

40 mg/ml Oral suspension Oral use

281

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INN Invented name Strength Pharmaceutical form

Route of administration

Spain Laboratorio Aldo Union, S.A. Baronesa de Malda, 73 Esplugues de Llobregat Barcelona 08950 Spain

Ibuprofen PAIDOFEBRIL 20 mg/ml SUSPENSIÓN ORAL

20 mg/ml Oral suspension Oral use

Spain LABORATORIOS JUVENTUS, S.A. Julián Camarillo, 37 Madrid, 28037 Spain

Ibuprofen PIREXIN 40 mg/ml SUSPENSION ORAL

40 mg/ml Oral suspension Oral use

Spain RATIOPHARM ESPAÑA, S.A. Avda. de Burgos, 16 D-5ª planta 28036 Madrid Spain

Ibuprofen RATIODOL 20 mg/ ml SUSPENSION ORAL

20 mg/ml Oral suspension Oral use

Spain FARDI, S.A. (APLICACIONES FARMACODINAMICAS) Grassot, 16 Barcelona, 08025 Spain

Ibuprofen lysinate ALGIDRIN 600 POLVO PARA SUSPENSION ORAL

600 mg Powder for oral suspension

Oral use

Spain FARDI, S.A. (APLICACIONES FARMACODINAMICAS) Grassot, 16 Barcelona, 08025 Spain

Ibuprofen lysinate ALGIFAST 400 mg POLVO PARA SUSPENSION ORAL

400 mg Powder for oral suspension

Oral use

282

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Spain FARDI, S.A. (APLICACIONES FARMACODINAMICAS) Grassot, 16 Barcelona, 08025 Spain

Ibuprofen lysinate ALOGESIA 600 POLVO PARA SUSPENSION ORAL

600 mg Powder for oral suspension

Oral use

Spain FARDI, S.A. (APLICACIONES FARMACODINAMICAS) Grassot, 16 Barcelona, 08025 Spain

Ibuprofen lysinate DOLORAC 600 mg POLVO PARA SUSPENSION ORAL

600 mg Powder for oral suspension

Oral use

Spain FARDI, S.A. (APLICACIONES FARMACODINAMICAS) Grassot, 16 Barcelona, 08025 Spain

Ibuprofen lysinate NORVECTAN 600 POLVO PARA SUSPENSION ORAL

600 mg Powder for oral suspension

Oral use

Spain PHARMADIET, S.L.U. C/ Blanquers, 85 Banyoles, 17820 Spain

Ibuprofen lysinate FENOSPIN 400 mg POLVO PARA SOLUCION ORAL

400 mg Powder for oral solution

Oral use

Spain Reckitt Benckiser Healthcare S.A. Mataró, 28. Granollers (Barcelona), 08403 Spain

Ibuprofen lysinate NUROFEN FAST (LISINA) 400 MG POLVO PARA SOLUCION ORAL

400 mg Powder for oral solution

Oral use

283

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Spain Abbott Laboratories, S.A. Avda. de Burgos, 91 28050 Madrid Spain

Ibuprofen DALSY 200 mg GRANULADO EFERVESCENTE

200 mg Effervescent granules Oral use

Spain Abbott Laboratories, S.A. Avda. de Burgos, 91 28050 Madrid Spain

Ibuprofen DALSY 400 MG GRANULADO EFERVESCENTE

400 mg Effervescent granules Oral use

Spain Abbott Laboratories, S.A. Avda. de Burgos, 91 28050 Madrid Spain

Ibuprofen IBUPROFENO ABBOTT 600 GRANULADO EFERVESCENTE EFG

600 mg Effervescent granules Oral use

Spain KERN PHARMA, S.L. Venus, 72. Poligono Industrial Colon II. Tarrasa (Barcelona) 08228 Spain

Ibuprofen IBUKERN 600 MG GRANULADO EFERVESCENTE EFG

600 mg Effervescent granules Oral use

Spain KERN PHARMA, S.L. Venus, 72. Poligono Industrial Colon II. Tarrasa (Barcelona) 08228 Spain

Ibuprofen IBUPROFENO KERN PHARMA 200 mg GRANULADO EFERVESCENTE EFG

200 mg Effervescent granules Oral use

Spain KERN PHARMA, S.L. Venus, 72. Poligono Industrial Colon II. Tarrasa (Barcelona) 08228 Spain

Ibuprofen IBUPROFENO KERN PHARMA 600 mg GRANULADO EFERVESCENTE EFG

600 mg Effervescent granules Oral use

284

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Spain PENSA PHARMA, S.A.U. Jorge Comín (médico pediatra), 3 46015 Valencia Spain

Ibuprofen IBUPROFENO PENSA 600 mg GRANULADO EFERVESCENTE EFG

600 mg Effervescent granules Oral use

Spain Abbott Laboratories, S.A. Avda. de Burgos, 91 28050 Madrid Spain

Ibuprofen NEOBRUFEN 600 mg GRANULADO EFERVESCENTE

600 mg Effervescent granules Oral use

Spain ZAMBON, S.A. Maresme, 5 Polígono Can Bernardes-Subirá 08130 Sta. Perpetua de la Mogoda (Barcelona) Spain

Ibuprofen arginine ESPIDIDOL 400 mg GRANULADO PARA SOLUCION ORAL SABOR LIMON

400 mg Granules for oral solution

Oral use

Spain ZAMBON, S.A. Maresme, 5 Polígono Can Bernardes-Subirá 08130 Sta. Perpetua de la Mogoda (Barcelona) Spain

Ibuprofen arginine ESPIDIDOL 400 mg GRANULADO PARA SOLUCION ORAL SABOR MENTA

400 mg Granules for oral solution

Oral use

285

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Spain ZAMBON, S.A. Maresme, 5 Polígono Can Bernardes-Subirá 08130 Sta. Perpetua de la Mogoda (Barcelona) Spain

Ibuprofen arginine ESPIDIFEN 400 mg GRANULADO PARA SOLUCION ORAL SABOR MENTA

400 mg Granules for oral solution

Oral use

Spain ZAMBON, S.A. Maresme, 5 Polígono Can Bernardes-Subirá 08130 Sta. Perpetua de la Mogoda (Barcelona) Spain

Ibuprofen arginine ESPIDIFEN 600 mg GRANULADO PARA SOLUCION ORAL SABOR ALBARICOQUE

600 mg Granules for oral solution

Oral use

Spain ZAMBON, S.A. Maresme, 5 Polígono Can Bernardes-Subirá 08130 Sta. Perpetua de la Mogoda (Barcelona) Spain

Ibuprofen arginine ESPIDIFEN 600 mg GRANULADO PARA SOLUCION ORAL SABOR MENTA EFG

600 mg Granules for oral solution

Oral use

Spain Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofen arginine FEBRIROL 200 MG GRANULADO PARA SOLUCION ORAL

200 mg Granules for oral solution

Oral use

286

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Spain LABORATORIOS CINFA, S.A. Olaz-Chipi, 10 Polígono Industrial Areta 31620 Huarte-Pamplona (Navarra) Spain

Ibuprofen arginine IBUPROFENO (ARGININA) CINFA 400 mg GRANULADO PARA SOLUCION ORAL EFG

400 mg Granules for oral solution

Oral use

Spain LABORATORIOS CINFA, S.A. Olaz-Chipi, 10 Polígono Industrial Areta 31620 Huarte-Pamplona (Navarra) Spain

Ibuprofen arginine IBUPROFENO (ARGININA) CINFA 600 mg GRANULADO PARA SOLUCION ORAL EFG

600 mg Granules for oral solution

Oral use

Spain LABORATORIOS CINFA, S.A. Olaz-Chipi, 10 Polígono Industrial Areta 31620 Huarte-Pamplona (Navarra) Spain

Ibuprofen arginine IBUPROFENO (ARGININA) CINFAMED 400 mg GRANULADO PARA SOLUCION ORAL EFG

400 mg Granules for oral solution

Oral use

Spain LABORATORIOS CINFA, S.A. Olaz-Chipi, 10 Polígono Industrial Areta 31620 Huarte-Pamplona (Navarra) Spain

Ibuprofen arginine IBUPROFENO (ARGININA) CINFAMED 600 mg GRANULADO PARA SOLUCION ORAL EFG

600 mg Granules for oral solution

Oral use

287

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Spain Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofen arginine IBUPROFENO (ARGININA) CODRAMOL 400 mg GRANULADO PARA SOLUCION ORAL EFG

400 mg Granules for oral solution

Oral use

Spain Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofen arginine IBUPROFENO (ARGININA) CODRAMOL 600 mg GRANULADO PARA SOLUCION ORAL EFG

600 mg Granules for oral solution

Oral use

Spain LABORATORIOS COMBIX, S.L.U. Badajoz, 2, Edificio 2 28223 Pozuelo de Alarcón (Madrid) Spain

Ibuprofen arginine IBUPROFENO (ARGININA) COMBIX 600 mg GRANULADO PARA SOLUCION ORAL EFG

600 mg Granules for oral solution

Oral use

Spain Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofen arginine IBUPROFENO (ARGININA) FARMALIDER 200 MG GRANULADO PARA SOLUCION ORAL

200 mg Granules for oral solution

Oral use

Spain KERN PHARMA, S.L. Venus, 72. Poligono Industrial Colon II. Tarrasa (Barcelona) 08228 Spain

Ibuprofen arginine IBUPROFENO (ARGININA) KERN PHARMA 600 mg GRANULADO PARA SOLUCION ORAL EFG

600 mg Granules for oral solution

Oral use

288

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Spain MYLAN PHARMACEUTICALS, S.L. Plom 2-4, 5º planta 08038 Barcelona Spain

Ibuprofen arginine IBUPROFENO (ARGININA) MYLAN 600 mg GRANULADO PARA SOLUCION ORAL EFG

600 mg Granules for oral solution

Oral use

Spain LABORATORIOS NORMON, S.A. Ronda de Valdecarrizo, 6 Tres Cantos (Madrid), 28670 Spain

Ibuprofen arginine IBUPROFENO (ARGININA) NORMON 400 mg GRANULADO PARA SOLUCION ORAL EFG

400 mg Granules for oral solution

Oral use

Spain LABORATORIOS NORMON, S.A. Ronda de Valdecarrizo, 6 Tres Cantos (Madrid), 28670 Spain

Ibuprofen arginine IBUPROFENO (ARGININA) NORMON 600 mg GRANULADO PARA SOLUCION ORAL EFG

600 mg Granules for oral solution

Oral use

Spain PENSA PHARMA, S.A.U. Jorge Comín (médico pediatra), 3 46015 Valencia Spain

Ibuprofen arginine IBUPROFENO (ARGININA) PENSA 600 mg GRANULADO PARA SOLUCION ORAL EFG

600 mg Granules for oral solution

Oral use

Spain RATIOPHARM ESPAÑA, S.A. Avda. de Burgos, 16 D-5ª planta 28036 Madrid Spain

Ibuprofen arginine IBUPROFENO (ARGININA) RATIOPHARM 600 mg GRANULADO PARA SOLUCION ORAL EFG

600 mg Granules for oral solution

Oral use

289

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Spain SANDOZ FARMACÉUTICA, S.A. Avda. Osa Mayor 28023 Aravaca (Madrid) Spain

Ibuprofen arginine IBUPROFENO (ARGININA) SANDOZ 600 mg GRANULADO PARA SOLUCION ORAL EFG

600 mg Granules for oral solution

Oral use

Spain LABORATORIO STADA, S.A. Frederic Mompou, 5 08960 Sant Just Desvern (Barcelona) Spain

Ibuprofen arginine IBUPROFENO (ARGININA) STADA 600 mg GRANULADO PARA SOLUCION ORAL EFG

600 mg Granules for oral solution

Oral use

Spain TARBIS FARMA, S.L. Gran Via Carlos III, 94 Barcelona, 08028 Spain

Ibuprofen arginine IBUPROFENO (ARGININA) TARBIS 600 mg GRANULADO PARA SOLUCION ORAL EFG

600 mg Granules for oral solution

Oral use

Spain TECNIMEDE ESPAÑA INDUSTRIA FARMACEUTICA, S.A. Avda. de Bruselas, 13 3º D.Edificio América Polígono Arroyo de la Vega Alcobendas (Madrid), 28108 Spain

Ibuprofen arginine IBUPROFENO (ARGININA) TECNIGEN 600 mg GRANULADO PARA SOLUCION ORAL EFG

600 mg Granules for oral solution

Oral use

Spain TEVA PHARMA, S.L.U. Anabel Segura, 11 Edificio Albatros B, 1ª planta 28108 Alcobendas (Madrid) Spain

Ibuprofen IBUPROFENO (ARGININA) TEVA 600 mg GRANULADO PARA SOLUCIÓN ORAL EFG

600 mg Granules for oral solution

Oral use

290

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INN Invented name Strength Pharmaceutical form

Route of administration

Spain Zentiva, k.s. U kabelovny 130 102 37 Praha 10 Dolní Měcholupy Czech Republic

Ibuprofen arginine IBUPROFENO (ARGININA) ZENTIVA 600 mg GRANULADO PARA SOLUCION ORAL EFG

600 mg Granules for oral solution

Oral use

Spain LABORATORIOS NORMON, S.A. Ronda de Valdecarrizo, 6 Tres Cantos (Madrid), 28670 Spain

Ibuprofen arginine NORMODOL 400 mg GRANULADO PARA SOLUCION ORAL EFG

400 mg Granules for oral solution

Oral use

Spain Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofen arginine POINDOL 200 MG GRANULADO PARA SOLUCION ORAL

200 mg Granules for oral solution

Oral use

Spain Boehringer Ingelheim International GmbH Binger Straße 173 55216 Ingelheim am Rhein Germany

Ibuprofen BUSCAFEM 400 MG CAPSULAS BLANDAS EFG

400 mg Capsule, soft Oral use

Spain Ceninter, S.A. Avda. San Pablo, 27 Coslada (Madrid), 28823 Spain

Ibuprofen DOLENCAR 200 mg CAPSULAS BLANDAS

200 mg Capsule, soft Oral use

Spain Ceninter, S.A. Avda. San Pablo, 27 Coslada (Madrid), 28823 Spain

Ibuprofen DOLENCAR 400 mg CAPSULAS BLANDAS

400 mg Capsule, soft Oral use

291

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Spain Juste, S.A.Q.F. Avda. San Pablo, 27 Coslada (Madrid) 28823 Spain

Ibuprofen DOLTRA 200 mg CAPSULAS BLANDAS

200 mg Capsule, soft Oral use

Spain Juste, S.A.Q.F. Avda. San Pablo, 27 Coslada (Madrid) 28823 Spain

Ibuprofen DOLTRA 400 mg CAPSULAS BLANDAS

400 mg Capsule, soft Oral use

Spain Reckitt Benckiser Healthcare S.A. Mataró, 28. Granollers (Barcelona), 08403 Spain

Ibuprofen NUROFEN 400 mg CAPSULAS BLANDAS

400 mg Capsule, soft Oral use

Spain LABORATORIOS GEBRO PHARMA, S.A. Avenida Tibidabo, 29 08022 Barcelona Spain

Dexibuprofen ATRISCAL 300 mg comprimidos recubiertos con película

300 mg Film-coated tablet Oral use

Spain LABORATORIOS GEBRO PHARMA, S.A. Avenida Tibidabo, 29 08022 Barcelona Spain

Dexibuprofen ATRISCAL 400 mg comprimidos recubiertos con película

400 mg Film-coated tablet Oral use

292

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Spain LABORATORIOS GEBRO PHARMA, S.A. Avenida Tibidabo, 29 08022 Barcelona Spain

Dexibuprofen SERACTIL 400 mg comprimidos recubiertos con película

400 mg Film-coated tablet Oral use

Spain FARMASIERRA LABORATORIOS, S.L. Ctra. Irún, km.26,200 San Sebastián de los Reyes (Madrid) 28700 Spain

Ibuprofen codeine phosphate hemihydrate

ASTEFOR 400 mg/30 mg comprimidos recubiertos con película

400 mg 30 mg

Film-coated tablet Oral use

Spain Abbott Laboratories, S.A. Avda. de Burgos, 91 28050 Madrid Spain

Ibuprofen codeine phosphate hemihydrate

NEOBRUFEN CON CODEÍNA 400 mg/30 mg comprimidos recubiertos con película

400 mg 30 mg

Film-coated tablet Oral use

Spain Cantabria Pharma, S.L. Ribera del Loira, 46 edificio 2 28042 Madrid Spain

Ibuprofen codeine phosphate hemihydrate

NIDOL 400 mg/30 mg comprimidos recubiertos con película

400 mg 30 mg

Film-coated tablet Oral use

Spain Boehringer Ingelheim International GmbH Binger Straße 173 55216 Ingelheim am Rhein Germany

Ibuprofen pseudoephedrine hydrochloride

BISOLFREN 200 mg/30 mg comprimidos recubiertos con película

200 mg 30 mg

Film-coated tablet Oral use

293

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Spain FARMASIERRA LABORATORIOS, S.L. Ctra. Irún, km.26,200 San Sebastián de los Reyes (Madrid) 28700 Spain

Ibuprofen codeine phosphate hemihydrate

ASTEFOR 400 mg/30 mg GRANULADO PARA SUSPENSION ORAL

400 mg 30 mg

Granules for oral suspension

Oral use

Spain KERN PHARMA, S.L. Venus, 72. Poligono Industrial Colon II. Tarrasa (Barcelona) 08228 Spain

Ibuprofen arginine codeine phosphate hemihydrate

IBUKERN (ARGININA) CODEINA 200 MG/ML + 10 MG/ML SOLUCION ORAL

200 mg/ml 10 mg/ml

Oral solution Oral use

Spain Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofen arginine codeine phosphate hemihydrate

IBUCOD 200 MG/ML + 10 MG/ML SOLUCION ORAL

200 mg/ml 10 mg/ml

Oral solution Oral use

Spain LABORATORIOS SALVAT, S.A. Gall, 30-36 Esplugues de Llobregat (Barcelona) 08950 Spain

Ibuprofen caffeine dimenhydrinate

SALVARINA CAPSULAS 200 mg 50 mg 15 mg

Capsule, hard Oral use

294

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Spain LABORATORIOS PEREZ GIMENEZ, S.A. Polígono Industrial Los Mochos Polígono 8-parcela 20. Crta. A-431, Km. 19 14720 Almodovar del Río (Córdoba) Spain

Ibuprofen IBUPROFENO CUVE 600 mg comprimidos EFG

600 mg Film-coated tablet Oral use

Spain LABORATORIOS PEREZ GIMENEZ, S.A. Pol. Ind. Los Mochos. Polígono 8 - Parcela 20. Crta. A-431, Km 19, Almodovar del Río (Córdoba), 14720, Spain.

Ibuprofen arginine IBUPROFENO (ARGININA) CUVE 600 mg GRANULADO PARA SOLUCION ORAL EFG

600 mg Granules for oral solution

Oral use

Spain LABORATORIOS ASOCIADOS NUPEL, S.L. Rua Carpinteiros, 25 Polígono Industrial Ceao 27003 Lugo Spain

Ibuprofen IBUPROFENO NUPEL 600 mg comprimidos

600 mg Film-coated tablet Oral use

Sweden Recip AB P.O Box 906 SE-170 09 Solna Sweden

Ibuprofen Alindrin 600 mg Film-coated tablet Oral use

295

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Sweden Recip AB P.O Box 906 SE-170 09 Solna Sweden

Ibuprofen Alindrin 200 mg Film-coated tablet Oral use

Sweden Recip AB P.O Box 906 SE-170 09 Solna Sweden

Ibuprofen Alindrin 400 mg Film-coated tablet Oral use

Sweden Mundipharma AB, Mölndalsvägen 30 B SE-412 63 Göteborg, Sweden

Ibuprofen codeine phosphate hemihydrate

Ardinex 200 mg 30 mg

Tablet Oral use

Sweden Abbott Scandinavia AB P.O Box 1498 SE-171 29 Solna Sweden

Ibuprofen Brufen 400 mg Effervescent granules Oral use

Sweden Abbott Scandinavia AB P.O Box 1498 SE-171 29 Solna Sweden

Ibuprofen Brufen 200 mg Film-coated tablet Oral use

Sweden Abbott Scandinavia AB P.O Box 1498 SE-171 29 Solna Sweden

Ibuprofen Brufen 400 mg Film-coated tablet Oral use

Sweden Abbott Scandinavia AB P.O Box 1498 SE-171 29 Solna Sweden

Ibuprofen Brufen 20 mg/ml Oral suspension Oral use

296

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Sweden Abbott Scandinavia AB P.O Box 1498 SE-171 29 Solna Sweden

Ibuprofen Brufen 600 mg Film-coated tablet Oral use

Sweden Abbott Scandinavia AB P.O Box 1498 SE-171 29 Solna Sweden

Ibuprofen Brufen Retard 800 mg Prolonged-release tablet

Oral use

Sweden Orion Corporation Orionintie 1 FIN-02200 Espoo Finland

Ibuprofen Burana 800 mg Film-coated tablet Oral use

Sweden Orion Corporation Orionintie 1 FIN-02200 Espoo Finland

Ibuprofen Burana 200 mg Film-coated tablet Oral use

Sweden Orion Corporation Orionintie 1 FIN-02200 Espoo Finland

Ibuprofen Burana 400 mg Film-coated tablet Oral use

Sweden Orion Corporation Orionintie 1 FIN-02200 Espoo Finland

Ibuprofen Burana 600 mg Film-coated tablet Oral use

Sweden Orion Corporation Orionintie 1 FIN-02200 Espoo Finland

Ibuprofen codeine phosphate hemihydrate

Burana Comp 200 mg 30 mg

Film-coated tablet Oral use

297

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Sweden Orion Corporation Orionintie 1 FIN-02200 Espoo Finland

Ibuprofen codeine phosphate hemihydrate

Burana Comp 400 mg/60 mg

Film-coated tablet Oral use

Sweden Infirst Healthcare Ltd. Strand 265 London WC2R 1BH United Kingdom

Ibuprofen Flarin 200 mg Capsule, soft Oral use

Sweden Infirst Healthcare Ltd. Strand 265 London WC2R 1BH United Kingdom

Ibuprofen Flarin 400 mg Capsule, soft Oral use

Sweden Vitabalans Oy Varastokatu 8 FI-13500 Tavastehus Finland

Ibuprofen Ibumax 200 mg Film-coated tablet Oral use

Sweden Vitabalans Oy Varastokatu 8 FI-13500 Tavastehus Finland

Ibuprofen Ibumax 400 mg Film-coated tablet Oral use

Sweden Vitabalans Oy Varastokatu 8 FI-13500 Tavastehus Finland

Ibuprofen Ibumax 600 mg Film-coated tablet Oral use

Sweden Takeda Pharma AB P.O Box 3131 SE-169 03 Solna Sweden

Ibuprofen Ibumetin 200 mg Tablet Oral use

298

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Sweden Takeda Pharma AB P.O Box 3131 SE-169 03 Solna Sweden

Ibuprofen Ibumetin 400 mg Tablet Oral use

Sweden Takeda Pharma AB P.O Box 3131 SE-169 03 Solna Sweden

Ibuprofen Ibumetin 600 mg Tablet Oral use

Sweden Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Ibuprofen Actavis 200 mg Film-coated tablet Oral use

Sweden Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Ibuprofen Actavis 400 mg Film-coated tablet Oral use

Sweden Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Ibuprofen Actavis 600 mg Film-coated tablet Oral use

Sweden Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Ibuprofen Actavis 800 mg Film-coated tablet Oral use

299

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Sweden Apofri AB P.O Box 120 SE-182 12 Danderyd Sweden

Ibuprofen Ibuprofen Apofri 200 mg Film-coated tablet Oral use

Sweden Apofri AB P.O Box 120 SE-182 12 Danderyd Sweden

Ibuprofen Ibuprofen Apofri 400 mg Film-coated tablet Oral use

Sweden Banner Pharmacaps Europe B.V. De Posthoornstraat 7 5048 AS Tilburg The Netherlands

Ibuprofen Ibuprofen Banner 400 mg Capsule, soft Oral use

Sweden Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofen Ibuprofen Farmalider 20 mg/ml Oral suspension Oral use

Sweden Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain

Ibuprofen Ibuprofen Farmalider 40 mg/ml Oral suspension Oral use

Sweden Orifarm Generics A/S Energivej 15 POB 69 DK-5260 Odense S Denmark

Ibuprofen Ibuprofen Orifarm 200 mg Film-coated tablet Oral use

300

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Sweden Orifarm Generics A/S Energivej 15 POB 69 DK-5260 Odense S Denmark

Ibuprofen Ibuprofen Orifarm 400 mg Film-coated tablet Oral use

Sweden Orifarm Generics A/S Energivej 15 POB 69 DK-5260 Odense S Denmark

Ibuprofen Ibuprofen Orifarm 600 mg Film-coated tablet Oral use

Sweden ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen Ibuprofen ratiopharm 200 mg Film-coated tablet Oral use

Sweden ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Ibuprofen Ibuprofen ratiopharm 400 mg Film-coated tablet Oral use

Sweden Apofri AB P.O Box 120 SE-182 12 Danderyd Sweden

Ibuprofen lysine Ibuzin 400 mg Film-coated tablet Oral use

Sweden Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Ifenin 200 mg Film-coated tablet Oral use

301

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

Sweden Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Ifenin 400 mg Film-coated tablet Oral use

Sweden McNeil Sweden AB SE-169 90 Solna Sweden

Ibuprofen Ipren 200 mg Film-coated tablet Oral use

Sweden McNeil Sweden AB SE-169 90 Solna Sweden

Ibuprofen Ipren 400 mg Film-coated tablet Oral use

Sweden McNeil Sweden AB SE-169 90 Solna Sweden

Ibuprofen Ipren 400 mg Capsule, soft Oral use

Sweden Nordic Drugs AB Box 30035 200 61 Limhamn Sweden

Dexibuprofen Tradil 300 mg Film-coated tablet Oral use

Sweden Nordic Drugs AB Box 30035 200 61 Limhamn Sweden

Dexibuprofen Tradil 400 mg Film-coated tablet Oral use

The Netherlands

Abbott B.V Wegalaan 9 2132 JD HOOFDDORP The Netherlands

Ibuprofen Brufen Bruis, bruisgranulaat in sachets 600 mg

600 mg Effervescent granules Oral use

302

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

The Netherlands

Abbott B.V Wegalaan 9 2132 JD HOOFDDORP The Netherlands

Ibuprofen Brufen Retard, tabletten met gereguleerde afgifte 800 mg

800 mg Prolonged-release tablet

Oral use

The Netherlands

Abbott B.V Wegalaan 9 2132 JD HOOFDDORP The Netherlands

Ibuprofen Brufen 400 mg bruisgranulaat

400 mg Effervescent granules Oral use

The Netherlands

Actavis B.V. Baarnsche Dijk 1 3741 LN Baarn The Netherlands

Ibuprofen Ibuprofen Actavis Liquid Caps 400 mg, capsule, zacht

400 mg Capsule, soft Oral use

The Netherlands

Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Ibuprofen Actavis 200 mg, filmomhulde tabletten

200 mg Film-coated tablet Oral use

The Netherlands

Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Ibuprofen Actavis 400 mg, filmomhulde tabletten

400 mg Film-coated tablet Oral use

The Netherlands

Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Ibuprofen Actavis 400 mg, filmomhulde tabletten

400 mg Film-coated tablet Oral use

The Netherlands

Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland

Ibuprofen Ibuprofen Actavis 600 mg, filmomhulde tabletten

600 mg Film-coated tablet Oral use

303

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

The Netherlands

Apotex Europe BV Darwinweg 20 2333 CR Leiden The Netherlands

Ibuprofen Albert Heijn Ibuprofen 200 mg , omhulde tabletten

200 mg Coated tablet Oral use

The Netherlands

Apotex Europe BV Darwinweg 20 2333 CR Leiden The Netherlands

Ibuprofen Albert Heijn Ibuprofen 400 mg , omhulde tabletten

400 mg Coated tablet Oral use

The Netherlands

Apotex Europe B.V. Darwinweg 20 2333 CR Leiden The Netherlands

Ibuprofen Ibuprofen Apotex 200 mg, omhulde tabletten

200 mg Coated tablet Oral use

The Netherlands

Apotex Europe B.V. Darwinweg 20 2333 CR Leiden The Netherlands

Ibuprofen Ibuprofen Apotex 200 mg, tabletten

200 mg Film-coated tablet Oral use

The Netherlands

Apotex Europe B.V. Darwinweg 20 2333 CR Leiden The Netherlands

Ibuprofen Ibuprofen Apotex 400 mg capsules, zacht

400 mg Capsule, soft Oral use

The Netherlands

Apotex Europe B.V. Darwinweg 20 2333 CR Leiden The Netherlands

Ibuprofen Ibuprofen Apotex 400 mg, omhulde tabletten

400 mg Film-coated tablet Oral use

The Netherlands

Apotex Europe B.V. Darwinweg 20 2333 CR Leiden The Netherlands

Ibuprofen Ibuprofen Apotex 400 mg, omhulde tabletten

400 mg Coated tablet Oral use

304

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

The Netherlands

Apotex Europe B.V. Darwinweg 20 2333 CR Leiden The Netherlands

Ibuprofen Ibuprofen Apotex 400 mg, tabletten

400 mg Film-coated tablet Oral use

The Netherlands

Apotex Europe B.V. Darwinweg 20 2333 CR Leiden The Netherlands

Ibuprofen Ibuprofen Apotex 500 mg, zetpillen

500 mg Suppository Rectal use

The Netherlands

Apotex Europe B.V. Darwinweg 20 2333 CR Leiden The Netherlands

Ibuprofen Ibuprofen Apotex 600 mg, omhulde tabletten

600 mg Film-coated tablet Oral use

The Netherlands

Apotex Europe B.V. Darwinweg 20 2333 CR Leiden The Netherlands

Ibuprofen Ibuprofen Apotex 600 mg, tabletten

600 mg Film-coated tablet Oral use

The Netherlands

Apotex Europe B.V. Darwinweg 20 2333 CR Leiden The Netherlands

Ibuprofen Ibuprofen liquid caps Apotex 400 mg, capsules, zacht

400 mg Capsule, soft Oral use

The Netherlands

Banner Pharmacaps Europe B.V. De Posthoornstraat 7 5048 AS Tilburg The Netherlands

Ibuprofen Ibuprofen Banner 100 mg, kauwcapsules, zacht

100 mg Chewable capsule, soft

Oral use

305

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

The Netherlands

Banner Pharmacaps Europe B.V. De Posthoornstraat 7 5048 AS Tilburg The Netherlands

Ibuprofen Ibuprofen Banner 400 mg capsules, zacht

400 mg Capsule, soft Oral use

The Netherlands

Bayer B.V. Energieweg 1 3641 RT Mijdrecht The Netherlands

Ibuprofen Saridon ibuprofen 200 mg, filmomhulde tabletten

200 mg Film-coated tablet Oral use

The Netherlands

Bayer B.V. Energieweg 1 3641 RT Mijdrecht The Netherlands

Ibuprofen Sarixell 400 mg, filmomhulde tabletten

400 mg Film-coated tablet Oral use

The Netherlands

Centrafarm B.V. Nieuwe Donk 3 4879 AC Etten Leur The Netherlands

Ibuprofen Ibuprofen CF 600 mg, omhulde tabletten

600 mg Film-coated tablet Oral use

The Netherlands

Centrafarm B.V. Nieuwe Donk 3 4879 AC Etten Leur The Netherlands

Ibuprofen Ibuprofen CF 400 mg, omhulde tabletten

400 mg Film-coated tablet Oral use

The Netherlands

ETOS B.V. Provincialeweg 11 1506 MA Zaandam The Netherlands

Ibuprofen Etos Ibuprofen Liquid caps 400 mg, capsules, zacht

400 mg Capsule, soft Oral use

306

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

The Netherlands

Fair-Med Healthcare GmbH Planckstr. 13 22765 Hamburg Germany

Ibuprofen Ibuprofen FAIR-MED 200 mg filmomhulde tabletten

200 mg Film-coated tablet Oral use

The Netherlands

Fair-Med Healthcare GmbH Planckstr. 13 22765 Hamburg Germany

Ibuprofen Ibuprofen FAIR-MED 400 mg filmomhulde tabletten

400 mg Film-coated tablet Oral use

The Netherlands

Fair-Med Healthcare GmbH Planckstr. 13 22765 Hamburg Germany

Ibuprofen Ibuprofen FAIR-MED 600 mg filmomhulde tabletten

600 mg Film-coated tablet Oral use

The Netherlands

Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

Ibuprofen Ibuprofen Galpharm 200 mg, filmomhulde tabletten

200 mg Film-coated tablet Oral use

The Netherlands

Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

Ibuprofen Ibuprofen Galpharm 400 mg, filmomhulde tabletten

400 mg Film-coated tablet Oral use

307

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

The Netherlands

GenRx B.V. Dijkgraaf 30 6921 RL Duiven The Netherlands

Ibuprofen Ibuprofen 400 mg, tabletten

400 mg Film-coated tablet Oral use

The Netherlands

GenRx B.V. Dijkgraaf 30 6921 RL Duiven The Netherlands

Ibuprofen Ibuprofen 600 mg, tabletten

600 mg Film-coated tablet Oral use

The Netherlands

Healthypharm B.V. Nieuwe Donk 3 4879 AC Etten-Leur The Netherlands

Ibuprofen Ibuprofen HTP liquid caps 400 mg, capsules, zacht

400 mg Capsule, soft Oral use

The Netherlands

Healthypharm B.V. Nieuwe Donk 3 4879 AC Etten-Leur The Netherlands

Ibuprofen Ibuprofen HTP 200 mg, omhulde tabletten

200 mg Film-coated tablet Oral use

The Netherlands

Healthypharm B.V. Nieuwe Donk 3 4879 AC Etten-Leur The Netherlands

Ibuprofen Ibuprofen HTP 400 mg, omhulde tabletten

400 mg Film-coated tablet Oral use

The Netherlands

Healthypharm B.V. Nieuwe Donk 3 4879 AC Etten-Leur The Netherlands

Ibuprofen Ibuprofen liquid caps 400 mg HTP Huismerk, capsules, zacht

400 mg Capsule, soft Oral use

308

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

The Netherlands

HEMA B.V. NDSM-straat 10 1033 SB Amsterdam The Netherlands

Ibuprofen HEMA Ibuprofen 200 mg, omhulde tabletten

200 mg Film-coated tablet Oral use

The Netherlands

HEMA B.V. NDSM-straat 10 1033 SB Amsterdam The Netherlands

Ibuprofen Hema Ibuprofen 200 mg, omhulde tabletten

200 mg Coated tablet Oral use

The Netherlands

HTP Huisapotheek B.V. Nieuwe Donk 3 4879 AC Etten-Leur The Netherlands

Ibuprofen Ibuprofen 200 mg HTP Huisapotheek, omhulde tabletten

200 mg Coated tablet Oral use

The Netherlands

HTP Huisapotheek B.V. Nieuwe Donk 3 4879 AC Etten-Leur The Netherlands

Ibuprofen Ibuprofen 400 mg HTP Huisapotheek, omhulde tabletten

400 mg Coated tablet Oral use

The Netherlands

Infirst Healthcare Ltd. Strand 265 London WC2R 1BH United Kingdom

Ibuprofen Flarin 200 mg capsules, zacht

200 mg Capsule, soft Oral use

The Netherlands

Infirst Healthcare Ltd. Strand 265 London WC2R 1BH United Kingdom

Ibuprofen Flarin 400 mg capsules, zacht

400 mg Capsule, soft Oral use

The Netherlands

Jumbo Supermarkten B.V. Rijksweg 15 5462 CE Veghel The Netherlands

Ibuprofen JUMBO Ibuprofen 200 mg, omhulde tabletten

200 mg Film-coated tablet Oral use

309

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

The Netherlands

Leidapharm B.V. Archimedesweg 2 2333 CN Leiden The Netherlands

Ibuprofen Leidapharm Ibuprofen 400mg Liquid Caps, capsules, zacht

400 mg Capsule, soft Oral use

The Netherlands

MAE Holding BV Amsterdamsestraatweg 22 1391 AB Abcoude The Netherlands

Ibuprofen Ibuprofen MAE 200 mg, filmomhulde tabletten

200 mg Film-coated tablet Oral use

The Netherlands

MAE Holding BV Amsterdamsestraatweg 22 1391 AB Abcoude The Netherlands

Ibuprofen Ibuprofen Triangle Pharma 200 mg, omhulde tabletten

200 mg Coated tablet Oral use

The Netherlands

MAE Holding BV Amsterdamsestraatweg 22 1391 AB Abcoude The Netherlands

Ibuprofen Kruidvat Ibuprofen Liquid Caps 400 mg, capsules, zacht

400 mg Capsule, soft Oral use

The Netherlands

MAE Holding BV Amsterdamsestraatweg 22 1391 AB Abcoude The Netherlands

Ibuprofen Trekpleister Ibuprofen Liquid Caps 400 mg, capsules, zacht

400 mg Capsule, soft Oral use

The Netherlands

Focus Farma B.V Lagedijk 1-3 Koog aan de Zaan 1541 KA Nederland

Ibuprofen Ibuprofen 200 mg Focus Farma, filmomhulde tabletten

200 mg Film-coated tablet Oral use

310

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

The Netherlands

Focus Farma B.V Lagedijk 1-3 Koog aan de Zaan 1541 KA Nederland

Ibuprofen Ibuprofen 400 mg Focus Farma, filmomhulde tabletten

400 mg Film-coated tablet Oral use

The Netherlands

Focus Farma B.V Lagedijk 1-3 Koog aan de Zaan 1541 KA Nederland

Ibuprofen Ibuprofen 600 mg Focus Farma, filmomhulde tabletten

600 mg Film-coated tablet Oral use

The Netherlands

Mediq Farma B.V. Hertogswetering 159 3543 AS Utrecht The Netherlands

Ibuprofen Ibuprofen Mdq 200 mg, omhulde tabletten

200 mg Coated tablet Oral use

The Netherlands

Mediq Farma B.V. Hertogswetering 159 3543 AS Utrecht The Netherlands

Ibuprofen Ibuprofen Mdq 400 mg, omhulde tabletten

400 mg Coated tablet Oral use

The Netherlands

Mylan B.V. Dieselweg 25 3752 LB Bunschoten The Netherlands

Ibuprofen lysine Ibuprofen (als lysine) Mylan OTC 200 mg, filmomhulde tabletten

342 mg Film-coated tablet Oral use

The Netherlands

Mylan B.V. Dieselweg 25 3752 LB Bunschoten The Netherlands

Ibuprofen lysine Ibuprofen (als lysine) Mylan OTC 400 mg, filmomhulde tabletten

684 mg Film-coated tablet Oral use

311

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

The Netherlands

Mylan B.V. Dieselweg 25 3752 LB Bunschoten The Netherlands

Ibuprofen lysine Ibuprofen (als lysine) Mylan 200 mg, filmomhulde tabletten

342 mg Film-coated tablet Oral use

The Netherlands

Mylan B.V. Dieselweg 25 3752 LB Bunschoten The Netherlands

Ibuprofen lysine Ibuprofen (als lysine) Mylan 400 mg, filmomhulde tabletten

684 mg Film-coated tablet Oral use

The Netherlands

Mylan B.V. Dieselweg 25 3752 LB Bunschoten The Netherlands

Ibuprofen Ibuprofen Mylan 200 mg, omhulde tabletten

200 mg Film-coated tablet Oral use

The Netherlands

Mylan B.V. Dieselweg 25 3752 LB Bunschoten The Netherlands

Ibuprofen Ibuprofen Mylan 400 mg, omhulde tabletten

400 mg Film-coated tablet Oral use

The Netherlands

Mylan B.V. Dieselweg 25 3752 LB Bunschoten The Netherlands

Ibuprofen Ibuprofen Mylan 600 mg, omhulde tabletten

600 mg Film-coated tablet Oral use

The Netherlands

Nedac Sorbo B.V. Innovatie 1 6921 RN Duiven The Netherlands

Ibuprofen NEDAC SORBO Ibuprofen 200 mg, omhulde tabletten

200 mg Coated tablet Oral use

312

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

The Netherlands

Nedac Sorbo B.V. Innovatie 1 6921 RN Duiven The Netherlands

Ibuprofen NEDAC SORBO Ibuprofen 400 mg, omhulde tabletten

400 mg Coated tablet Oral use

The Netherlands

Nederlandse Service Apotheek Beheer B.V. Vonderweg 39a 7468 DC Enter The Netherlands

Ibuprofen Ibuprofen SAM 200 mg, omhulde tabletten

200 mg Coated tablet Oral use

The Netherlands

Nederlandse Service Apotheek Beheer B.V. Vonderweg 39a 7468 DC Enter The Netherlands

Ibuprofen Ibuprofen SAM 400 mg, omhulde tabletten

400 mg Coated tablet Oral use

The Netherlands

Pfizer bv Rivium Westlaan 142 2909 LD, Capelle a/d Ijssel The Netherlands

Ibuprofen Advil, dragees 200 mg 200 mg Coated tablet Oral use

The Netherlands

Pfizer bv Rivium Westlaan 142 2909 LD, Capelle a/d Ijssel The Netherlands

Ibuprofen Advil Liquid Caps 400, zachte capsules, 400 mg

400 mg Capsule, soft Oral use

The Netherlands

Pfizer bv Rivium Westlaan 142 2909 LD, Capelle a/d Ijssel The Netherlands

Ibuprofen Advil Liquid-Caps 200, zachte capsules 200 mg

200 mg Capsule, soft Oral use

313

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

The Netherlands

Pfizer bv Rivium Westlaan 142 2909 LD, Capelle a/d Ijssel The Netherlands

Ibuprofen Advil Ovaal 400, filmomhulde tabletten 400 mg

400 mg Film-coated tablet Oral use

The Netherlands

Pharmachemie B.V. Swensweg 5 2031 GA Haarlem The Netherlands

Ibuprofen Ibuprofen bruis 600 mg PCH, bruisgranulaat

600 mg Effervescent granules Oral use

The Netherlands

Pharmachemie B.V. Swensweg 5 2031 GA Haarlem The Netherlands

Ibuprofen Ibuprofen caps 200 mg PCH, capsule zacht

200 mg Capsule, soft Oral use

The Netherlands

Pharmachemie B.V. Swensweg 5 2031 GA Haarlem The Netherlands

Ibuprofen Ibuprofen liquid caps 200 mg PCH, capsules, zacht

200 mg Capsule, soft Oral use

The Netherlands

Pharmachemie B.V. Swensweg 5 2031 GA Haarlem The Netherlands

Ibuprofen Ibuprofen 200 PCH, omhulde tabletten 200 mg

200 mg Coated tablet Oral use

The Netherlands

Pharmachemie B.V. Swensweg 5 2031 GA Haarlem The Netherlands

Ibuprofen Ibuprofen 400 PCH, omhulde tabletten 400 mg

400 mg Coated tablet Oral use

The Netherlands

Pharmachemie B.V. Swensweg 5 2031 GA Haarlem The Netherlands

Ibuprofen Ibuprofen 500 PCH, zetpillen 500 mg

500 mg Suppository Rectal use

314

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

The Netherlands

Pharmachemie B.V. Swensweg 5 2031 GA Haarlem The Netherlands

Ibuprofen Ibuprofen 600 PCH, omhulde tabletten 600 mg

600 mg Film-coated tablet Oral use

The Netherlands

ratiopharm Nederland B.V. Florapark 4 2012 HK Haarlem The Netherlands

Ibuprofen Ibuprofen ratiopharm 400 mg, filmomhulde tabletten

400 mg Film-coated tablet Oral use

The Netherlands

Reckitt Benckiser Healthcare B.V. Siriusdreef 14 2132 WT Hoofddorp The Netherlands

Ibuprofen Nurofen Fastine Liquid Caps 400 mg, capsule, zacht

400 mg Capsule, soft Oral use

The Netherlands

Reckitt Benckiser Healthcare B.V. Siriusdreef 14 2132 WT Hoofddorp The Netherlands

Ibuprofen lysine Nurofen Omhulde Tabletten 200, omhulde tabletten 200 mg

342 mg Film-coated tablet Oral use

The Netherlands

Reckitt Benckiser Healthcare B.V. Siriusdreef 14 2132 WT Hoofddorp The Netherlands

Ibuprofen Nurofen Zavance Lea 200 mg liquid capsules, capsules, zacht

200 mg Capsule, soft Oral use

The Netherlands

Reckitt Benckiser Healthcare B.V. Siriusdreef 14 2132 WT Hoofddorp The Netherlands

Ibuprofen lysine Nurofen Zavance Oni 400 mg, poeder voor oraal gebruik

683,34 mg Oral powder Oral use

315

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

The Netherlands

Reckitt Benckiser Healthcare B.V. Siriusdreef 14 2132 WT Hoofddorp The Netherlands

Ibuprofen sodium dihydrate

Nurofen Zavance Tex 200 mg tablet, omhulde tabletten

256 mg Coated tablet Oral use

The Netherlands

Reckitt Benckiser Healthcare B.V. Siriusdreef 14 2132 WT Hoofddorp The Netherlands

Ibuprofen sodium dihydrate

Nurofen Zavance Tex 200 mg tablet ovaal, omhulde tabletten

256 mg Coated tablet Oral use

The Netherlands

Reckitt Benckiser Healthcare B.V. Siriusdreef 14 2132 WT Hoofddorp The Netherlands

Ibuprofen sodium dihydrate

Nurofen Zavance Tex 400 mg tablet, omhulde tabletten

512 mg Coated tablet Oral use

The Netherlands

Reckitt Benckiser Healthcare B.V. Siriusdreef 14 2132 WT Hoofddorp The Netherlands

Ibuprofen Nurofen 200 lemon smelttablet, smelttabletten 200 mg

200 mg Orodispersible tablet Oral use

The Netherlands

Reckitt Benckiser Healthcare B.V. Siriusdreef 14 2132 WT Hoofddorp The Netherlands

Ibuprofen Nurofen 200 tablet, omhulde tabletten 200 mg

200 mg Coated tablet Oral use

316

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

The Netherlands

Reckitt Benckiser Healthcare B.V. Siriusdreef 14 2132 WT Hoofddorp The Netherlands

Ibuprofen Nurofen 200 tablet ovaal, omhulde tabletten 200 mg

200 mg Coated tablet Oral use

The Netherlands

Reckitt Benckiser Healthcare B.V. Siriusdreef 14 2132 WT Hoofddorp The Netherlands

Ibuprofen Nurofen 400 orange bruisgranulaat, bruisgranulaat 400 mg per sachet

400 mg Effervescent granules Oral use

The Netherlands

Reckitt Benckiser Healthcare B.V. Siriusdreef 14 2132 WT Hoofddorp The Netherlands

Ibuprofen lysine Nurofen 400 tablet Female, filmomhulde tabletten 400mg

684 mg Film-coated tablet Oral use

The Netherlands

Reckitt Benckiser Healthcare B.V. Siriusdreef 14 2132 WT Hoofddorp The Netherlands

Ibuprofen lysine Nurofen 400 tablet Migraine, filmomhulde tabletten 400 mg

684 mg Film-coated tablet Oral use

The Netherlands

Reckitt Benckiser Healthcare B.V. Siriusdreef 14 2132 WT Hoofddorp The Netherlands

Ibuprofen Nurofen 400 tablet, omhulde tabletten 400 mg

400 mg Film-coated tablet Oral use

317

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

The Netherlands

RXT Amsterdamsestraatweg 22 1391 AB Abcoude The Netherlands

Ibuprofen Ibuprofen RXT 200 mg, omhulde tabletten

200 mg Coated tablet Oral use

The Netherlands

Sameko Farma B.V. Archimedesweg 2 2333 CN Leiden The Netherlands

Ibuprofen C1000 Ibuprofen 200 mg, omhulde tabletten

200 mg Coated tablet Oral use

The Netherlands

Sameko Farma B.V. Archimedesweg 2 2333 CN Leiden The Netherlands

Ibuprofen Ibuprofen 200 mg Sameko, omhulde tabletten

200 mg Coated tablet Oral use

The Netherlands

Sameko Farma B.V. Archimedesweg 2 2333 CN Leiden The Netherlands

Ibuprofen Ibuprofen 400 mg Sameko, omhulde tabletten

400 mg Coated tablet Oral use

The Netherlands

Sameko Farma B.V. Archimedesweg 2 2333 CN Leiden The Netherlands

Ibuprofen Ibuprofen 400 mg Sameko, omhulde tabletten

400 mg Coated tablet Oral use

The Netherlands

Sameko Farma B.V. Archimedesweg 2 2333 CN Leiden The Netherlands

Ibuprofen Ibuprofen 400 mg Sameko, omhulde tabletten

400 mg Coated tablet Oral use

318

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

The Netherlands

Samenwerkende Apothekers Nederland B.V. Kralingseweg 201 3062 CE Rotterdam The Netherlands

Ibuprofen Ibuprofen 200 mg omhulde tabletten Samenwerkende Apothekers, omhulde tabletten

200 mg Coated tablet Oral use

The Netherlands

Samenwerkende Apothekers Nederland B.V. Kralingseweg 201 3062 CE Rotterdam The Netherlands

Ibuprofen Ibuprofen 400 mg omhulde tabletten Samenwerkende Apothekers, omhulde tabletten

400 mg Coated tablet Oral use

The Netherlands

Sandoz B.V. Veluwezoom 22 1327 AH Almere The Netherlands

Ibuprofen Ibuprofen Sandoz 200 mg, capsules, zacht

200 mg Capsule, soft Oral use

The Netherlands

Sandoz B.V. Veluwezoom 22 1327 AH Almere The Netherlands

Ibuprofen Ibuprofen Sandoz 400 mg, capsules, zacht

400 mg Capsule, soft Oral use

The Netherlands

SDG Farma B.V. Treubweg 11 1112 BA Diemen The Netherlands

Ibuprofen Idyl Ibuprofen Liquid Caps 400 mg, capsules, zacht

400 mg Capsule, soft Oral use

The Netherlands

Teva Nederland B.V. Swensweg 5 2031 GA Haarlem The Netherlands

Ibuprofen Ibuprofen Liquid caps 400 mg Teva, capsule, zacht

400 mg Capsule, soft Oral use

319

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

The Netherlands

Wrafton Laboratories Limited Exeter Road Wrafton Braunton Devon EX33 2DL United Kingdom

Ibuprofen lysine Ibuprofen Wrafton 200 mg, filmomhulde tabletten

342 mg Film-coated tablet Oral use

The Netherlands

Wrafton Laboratories Limited Exeter Road Wrafton Braunton Devon EX33 2DL United Kingdom

Ibuprofen lysine Ibuprofen Wrafton 400 mg, filmomhulde tabletten

684 mg Film-coated tablet Oral use

The Netherlands

Zambon Nederland B.V. Basicweg 14B 3821 BR Amersfoort The Netherlands

IBUPROFEN ARGININE

Zafen 200 bruistablet, bruistabletten 200 mg

200 mg Effervescent tablet Oral use

The Netherlands

Zambon Nederland B.V. Basicweg 14B 3821 BR Amersfoort The Netherlands

IBUPROFEN ARGININE

Zafen 400 granulaat, granulaat voor drank 400 mg

400 mg Granules for oral solution

Oral use

The Netherlands

Zambon Nederland B.V. Basicweg 14B 3821 BR Amersfoort The Netherlands

IBUPROFEN ARGININE

Zafen 400 Tablet, filmomhulde tabletten 400 mg

400 mg Film-coated tablet Oral use

320

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

The Netherlands

Zambon S.p.A. Via Lillo del Duca 10 20091, Bresso (Mi) Italy

IBUPROFEN ARGININE

Spidifen 400 tablet, filmomhulde tabletten 400 mg

400 mg Film-coated tablet Oral use

United Kingdom

Abbott Laboratories Limited Abbott House Vanwall Buisness Park Vanwall Road, Maidenhead Berkshire SL6 4XE United Kingdom

Ibuprofen BRUFEN TABLETS 200MG

200 mg Coated tablet Oral use

United Kingdom

Abbott Laboratories Limited Abbott House Vanwall Buisness Park Vanwall Road, Maidenhead Berkshire SL6 4XE United Kingdom

Ibuprofen BRUFEN TABLETS 400MG

400 mg Coated tablet Oral use

United Kingdom

Abbott Laboratories Limited Abbott House Vanwall Buisness Park Vanwall Road, Maidenhead Berkshire SL6 4XE United Kingdom

Ibuprofen BRUFEN TABLETS 600MG

600 mg Coated tablet Oral use

United Kingdom

Abbott Laboratories Limited Abbott House Vanwall Buisness Park Vanwall Road, Maidenhead Berkshire SL6 4XE United Kingdom

Ibuprofen BRUFEN ORAL GRANULES 600MG

600 mg Granules Oral use

321

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

United Kingdom

Abbott Laboratories Limited Abbott House Vanwall Buisness Park Vanwall Road, Maidenhead Berkshire SL6 4XE United Kingdom

Ibuprofen BRUFEN RETARD TABLETS 800MG

800 mg Modified-release tablet

Oral use

United Kingdom

Abbott Laboratories Limited Abbott House Vanwall Buisness Park Vanwall Road, Maidenhead Berkshire SL6 4XE United Kingdom

Ibuprofen BRUFEN SYRUP 100MG/5ML

20 mg/ml Syrup Oral use

United Kingdom

Abbott Laboratories Limited Abbott House Vanwall Buisness Park Vanwall Road, Maidenhead Berkshire SL6 4XE United Kingdom

Ibuprofen BRUFEN EFFERVESCENT GRANULES 400 MG

400 mg Effervescent granules Oral use

United Kingdom

Abbott Laboratories Limited Abbott House Vanwall Buisness Park Vanwall Road, Maidenhead Berkshire SL6 4XE United Kingdom

Ibuprofen ABBOTT LABS IBUPROFEN GRANULES 200 MG

200 mg Effervescent granules Oral use

322

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

United Kingdom

Abbott Laboratories Limited Abbott House Vanwall Buisness Park Vanwall Road, Maidenhead Berkshire SL6 4XE United Kingdom

Ibuprofen ABBOTT LABS IBUPROFEN GRANULES 600 MG

600 mg Effervescent granules Oral use

United Kingdom

Accord Healthcare Limited 5th Floor Charles House Finchley Road 108-110 London NW3 5JJ United Kingdom

Ibuprofen ACCORD HEALTHCARE IBUPROFEN TABLETS BP 200MG

200 mg Coated tablet Oral use

United Kingdom

Accord Healthcare Limited 5th Floor Charles House Finchley Road 108-110 London NW3 5JJ United Kingdom

Ibuprofen ACCORD HEALTHCARE IBUPROFEN TABLETS BP 400 MG

400 mg Coated tablet Oral use

United Kingdom

Accord Healthcare Limited 5th Floor Charles House Finchley Road 108-110 London NW3 5JJ United Kingdom

Ibuprofen ACCORD HEALTHCARE IBUPROFEN TABLETS BP 600 MG

600 mg Coated tablet Oral use

United Kingdom

Actavis UK Limited Whiddon Valley Barnstaple Devon EX32 8NS United Kingdom

Ibuprofen ACTAVIS IBUPROFEN TABLETS 200 MG

200 mg Coated tablet Oral use

323

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

United Kingdom

Actavis UK Limited Whiddon Valley Barnstaple Devon EX32 8NS United Kingdom

Ibuprofen ACTAVIS IBUPROFEN TABLETS 400MG

400 mg Coated tablet Oral use

United Kingdom

Actavis UK Limited Whiddon Valley Barnstaple Devon EX32 8NS United Kingdom

Ibuprofen ACTAVIS IBUPROFEN TABLETS 600MG

600 mg Coated tablet Oral use

United Kingdom

Activase Pharmaceuticals Limited Boumpoulinas Street 11 PO Box 27783 Nicosia CY-2433 Cyprus

Ibuprofen ACTIVASE PHARMACEUTICALS IBUPROFEN TABLETS 200MG

200 mg Film-coated tablet Oral use

United Kingdom

Activase Pharmaceuticals Limited Boumpoulinas Street 11 PO Box 27783 Nicosia CY-2433 Cyprus

Ibuprofen LIBROFEM TABLETS 200MG

200 mg Film-coated tablet Oral use

324

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

United Kingdom

Aspar Pharmaceutcals Limited 29-30 Capitol Way Capitol Way Industrial Park Colindale London NW9 0EQ United Kingdom

Ibuprofen ASPAR IBUPROFEN TABLETS BP 200MG

200 mg Coated tablet Oral use

United Kingdom

Aspar Pharmaceutcals Limited 29-30 Capitol Way Capitol Way Industrial Park Colindale London NW9 0EQ United Kingdom

Ibuprofen ASPAR IBUPROFEN TABLETS 400MG

400 mg Coated tablet Oral use

United Kingdom

Aspar Pharmaceutcals Limited 29-30 Capitol Way Capitol Way Industrial Park Colindale London NW9 0EQ United Kingdom

Ibuprofen ASPAR IBUPROFEN TABLETS 600MG

600 mg Coated tablet Oral use

United Kingdom

Aspar Pharmaceutcals Limited 29-30 Capitol Way Capitol Way Industrial Park Colindale London NW9 0EQ United Kingdom

Ibuprofen ASPAR IBUPROFEN CAPLETS 200MG

200 mg Coated tablet Oral use

325

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

United Kingdom

Aspar Pharmaceutcals Limited 29-30 Capitol Way Capitol Way Industrial Park Colindale London NW9 0EQ United Kingdom

Ibuprofen ASPAR IBUPROFEN TABLETS BP 200MG

200 mg Coated tablet Oral use

United Kingdom

Aspar Pharmaceutcals Limited 29-30 Capitol Way Capitol Way Industrial Park Colindale London NW9 0EQ United Kingdom

Ibuprofen ASPAR PHARMS IBUPROFEN TABLETS BP 400MG

400 mg Coated tablet Oral use

United Kingdom

Athlone Laboratories Limited, Ballymurray, Roscommon, Ireland

Ibuprofen ATHLONE LABS IBUPROFEN TABLETS BP 200MG

200 mg Coated tablet Oral use

United Kingdom

Athlone Laboratories Limited, Ballymurray, Roscommon, Ireland

Ibuprofen ATHLONE LABS IBUPROFEN TABLETS BP 400MG

400 mg Coated tablet Oral use

326

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INN Invented name Strength Pharmaceutical form

Route of administration

United Kingdom

Aurobindo Pharma Limited, Ares Block, Odyssey Business Park, West End Road Ruislip HA4 6QD United Kingdom

Ibuprofen AUROBINDO PHARMA IBUPROFEN TABLETS BP 200MG

200 mg Coated tablet Oral use

United Kingdom

Aurobindo Pharma Limited, Ares Block, Odyssey Business Park, West End Road Ruislip HA4 6QD United Kingdom

Ibuprofen AUROBINDO PHARMA IBUPROFEN TABLETS BP 400MG

400 mg Coated tablet Oral use

United Kingdom

Aurobindo Pharma Limited, Ares Block, Odyssey Business Park, West End Road Ruislip HA4 6QD United Kingdom

Ibuprofen AUROBINDO PHARMA IBUPROFEN TABLETS BP 600MG

600 mg Film-coated tablet Oral use

United Kingdom

Ayrton Saunders Limited North Way Wealworth Industrial Estate Andover, Hampshire SP10 5AZ United Kingdom

Ibuprofen SOLUBLE CUPROFEN IBUPROFEN TABLETS 200MG

200 mg Effervescent tablet Oral use

327

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

United Kingdom

Ayrton Saunders Limited North Way Wealworth Industrial Estate Andover, Hampshire SP10 5AZ United Kingdom

Ibuprofen DENTOGEN IBUPROFEN TABLETS BP 200MG

200 mg Film-coated tablet Oral use

United Kingdom

Ayrton Saunders Limited North Way Wealworth Industrial Estate Andover, Hampshire SP10 5AZ United Kingdom

Ibuprofen DENTOGEN SOLUBLE IBUPROFEN TABLETS 200MG

200 mg Effervescent tablet Oral use

United Kingdom

Ayrton Saunders Limited North Way Wealworth Industrial Estate Andover, Hampshire SP10 5AZ United Kingdom

Ibuprofen AYRTON SAUNDERS IBUPROFEN TABLETS 200MG

200 mg Effervescent tablet Oral use

United Kingdom

Ayrton Saunders Limited North Way Wealworth Industrial Estate Andover, Hampshire SP10 5AZ United Kingdom

Ibuprofen AYRTON SAUNDERS IBUPROFEN TABLETS 400MG

400 mg Effervescent tablet Oral use

328

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

United Kingdom

Ayrton Saunders Limited North Way Wealworth Industrial Estate Andover, Hampshire SP10 5AZ United Kingdom

Ibuprofen CUFEN-EF IBUPROFEN TABLETS 200 MG

200 mg Effervescent tablet Oral use

United Kingdom

Banner Pharmacaps Europe B.V. De Posthoornstraat 7 5048 AS Tilburg The Netherlands

Ibuprofen BANNER PHARMACAPS IBUPROFEN LIQUID CAPSULE 200MG

200 mg Capsule, soft Oral use

United Kingdom

Banner Pharmacaps Europe B.V. De Posthoornstraat 7 5048 AS Tilburg The Netherlands

Ibuprofen BANNER PHARMACAPS EUROPE BV IBUPROFEN CAPSULES, SOFT 400 MG

400 mg Capsule, soft Oral use

United Kingdom

Banner Pharmacaps Europe B.V. De Posthoornstraat 7 5048 AS Tilburg The Netherlands

Ibuprofen BANNER PHARMACAPS IBUPROFEN CHEWABLE CAPSULES 100MG

100 mg Capsule, soft Oral use

United Kingdom

Bell Sons & Company (Druggists) Limited Gifford House Slaidburn Crescent Southport, Merseyside PR9 9AL United Kingdom

Ibuprofen BELL SONS IBUPROFEN TABLETS 200MG

200 mg Coated tablet Oral use

329

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

United Kingdom

Bell Sons & Company (Druggists) Limited Gifford House Slaidburn Crescent Southport, Merseyside PR9 9AL United Kingdom

Ibuprofen BELL SONS IBUPROFEN CAPSULES 200MG

200 mg Capsule, soft Oral use

United Kingdom

Boehringer Ingelheim International GmbH Binger Straße 173 55216 Ingelheim am Rhein Germany

Ibuprofen pseudoephedrine hydrochloride

LASYNAC TABLETS 200MG/30MG

200 mg 30 mg

Film-coated tablet Oral use

United Kingdom

Bristol Laboratories Limited, Unit 3, Canalside Northbridge Road, Berkhamstead, Hertfordshire HP4 1EG United Kingdom

Ibuprofen BRISTOL LABS IBUPROFEN TABLETS 200MG

200 mg Coated tablet Oral use

United Kingdom

Bristol Laboratories Limited, Unit 3, Canalside Northbridge Road, Berkhamstead, Hertfordshire HP4 1EG United Kingdom

Ibuprofen BRISTOL LABS IBUPROFEN TABLETS 400MG

400 mg Coated tablet Oral use

330

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

United Kingdom

Bristol Laboratories Limited, Unit 3, Canalside Northbridge Road, Berkhamstead, Hertfordshire HP4 1EG United Kingdom

Ibuprofen BRISTOL LABS IBUPROFEN TABLETS 600MG

600 mg Film-coated tablet Oral use

United Kingdom

Bristol Laboratories Limited, Unit 3, Canalside Northbridge Road, Berkhamstead, Hertfordshire HP4 1EG United Kingdom

Ibuprofen EXTRA STRENGTH IBUPROFEN TABLETS 400MG

400 mg Coated tablet Oral use

United Kingdom

Bristol Laboratories Limited, Unit 3, Canalside Northbridge Road, Berkhamstead, Hertfordshire HP4 1EG United Kingdom

Ibuprofen FENBID BIPHASIC CAPSULES 400MG

400 mg Modified-release capsule

Oral use

United Kingdom

Chelonia Healthcare Limited Boumpoulinas 11 3rd Floor Nicosia CY-1060 Cyprus

Ibuprofen CHELONIA HEALTHCARE IBUPROFEN TABLETS 600MG

600 mg Film-coated tablet Oral use

United Kingdom

Chelonia Healthcare Limited Boumpoulinas 11 3rd Floor Nicosia CY-1060 Cyprus

Ibuprofen EBUFAC TABLETS 400 MG

400 mg Coated tablet Oral use

331

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

United Kingdom

Chelonia Healthcare Limited Boumpoulinas 11 3rd Floor Nicosia CY-1060 Cyprus

Ibuprofen MIGRAFEN TABLETS 200MG

200 mg Coated tablet Oral use

United Kingdom

Chelonia Healthcare Limited Boumpoulinas 11 3rd Floor Nicosia CY-1060 Cyprus

Ibuprofen MIGRAFEN TABLETS 200MG

200 mg Coated tablet Oral use

United Kingdom

Cipla (EU) Limited Hillbrow House Hillbrow Road Esher, Surrey KT10 9NW United Kingdom

Ibuprofen STD CHEMICALS IBUPROFEN ORAL SUSPENSION 100 MG/ 5 ML

20 mg/ml Oral suspension Oral use

United Kingdom

Crescent Pharma Limited Units 3 and 4 Quidhampton Business Units Polhampton Lane Overton, Hampshire RG25 3ED United Kingdom

Ibuprofen CRESCENT PHARMA IBUPROFEN TABLETS 200MG

200 mg Coated tablet Oral use

332

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

United Kingdom

Crescent Pharma Limited Units 3 and 4 Quidhampton Business Units Polhampton Lane Overton, Hampshire RG25 3ED United Kingdom

Ibuprofen CRESCENT PHARMA IBUPROFEN TABLETS 400MG

400 mg Coated tablet Oral use

United Kingdom

Crescent Pharma Limited Units 3 and 4 Quidhampton Business Units Polhampton Lane Overton, Hampshire RG25 3ED United Kingdom

Ibuprofen CRESCENT PHARMA IBUPROFEN TABLETS 600MG

600 mg Coated tablet Oral use

United Kingdom

Crescent Pharma Limited Units 3 and 4 Quidhampton Business Units Polhampton Lane Overton, Hampshire RG25 3ED United Kingdom

Ibuprofen CRESCENT PHARMA IBUPROFEN TABLETS BP 200 MG

200 mg Coated tablet Oral use

United Kingdom

Crescent Pharma Limited Units 3 and 4 Quidhampton Business Units Polhampton Lane Overton, Hampshire RG25 3ED United Kingdom

Ibuprofen CRESCENT PHARMA IBUPROFEN TABLETS BP 400 MG

400 mg Coated tablet Oral use

333

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

United Kingdom

Crookes Healthcare Limited, Regulatory Department Wellcroft House, Wellcroft Road, Slough, Berkshire SL1 4AQ United Kingdom

Ibuprofen NUROFEN RECOVERY 200 mg Orodispersible tablet Oral use

United Kingdom

Cupal Limited Regulatory Department Wellcroft House Wellcroft Road Slough, Berkshire SL1 4AQ United Kingdom

Ibuprofen CUPROFEN TABLETS BP 200MG

200 mg Coated tablet Oral use

United Kingdom

Cupal Limited Regulatory Department Wellcroft House Wellcroft Road Slough, Berkshire SL1 4AQ United Kingdom

Ibuprofen CUPROFEN TABLETS 400MG

400 mg Film-coated tablet Oral use

United Kingdom

Dalkeith Laboratories Limited 2 Park Street Woburn, Bedfordshire MK17 9PG United Kingdom

Ibuprofen DALKEITH LABS IBUPROFEN TABLETS BP 600MG

600 mg Film-coated tablet Oral use

334

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

United Kingdom

Dexcel Pharma Limited, 7 Sopwith Way, Drayton Fields Industrial Estate, Daventry Northamptonshire NN11 8PB United Kingdom

Ibuprofen DEXCEL IBUPROFEN LIQUID CAPSULES 200MG

200 mg Capsule, soft Oral use

United Kingdom

Dexcel Pharma Limited, 7 Sopwith Way, Drayton Fields Industrial Estate, Daventry Northamptonshire NN11 8PB United Kingdom

Ibuprofen DEXCEL IBUPROFEN LIQUID CAPSULES 400MG

400 mg Capsule, soft Oral use

United Kingdom

East Midlands Pharma Limited 16 Rancliffe Avenue Keyworth, Nottinghamshire NG12 5HY United Kingdom

Ibuprofen EAST MIDLANDS PHARMA IBUPROFEN MAXIMUM STRENGTH TABLETS 400MG

400 mg Coated tablet Oral use

United Kingdom

East Midlands Pharma Limited 16 Rancliffe Avenue Keyworth, Nottinghamshire NG12 5HY United Kingdom

Ibuprofen EAST MIDLANDS PHARMA IBUPROFEN TABLETS 200MG

200 mg Coated tablet Oral use

335

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

United Kingdom

Ennogen Pharma Limited Unit G4, Riverside Industrial Estate Riverside Way Dartford DA1 5BS United Kingdom

Ibuprofen ENNOGEN PHARMA IBUPROFEN TABLETS 200MG

200 mg Coated tablet Oral use

United Kingdom

Ennogen Pharma Limited Unit G4, Riverside Industrial Estate Riverside Way Dartford DA1 5BS United Kingdom

Ibuprofen ENNOGEN PHARMA IBUPROFEN TABLETS 400MG

400 mg Coated tablet Oral use

United Kingdom

Ennogen Pharma Limited Unit G4, Riverside Industrial Estate Riverside Way Dartford DA1 5BS United Kingdom

Ibuprofen ENNOGEN PHARMA IBUPROFEN TABLETS 600MG

600 mg Coated tablet Oral use

United Kingdom

Ennogen Pharma Limited Unit G4, Riverside Industrial Estate Riverside Way Dartford DA1 5BS United Kingdom

Ibuprofen IBULAR TABLETS 200MG

200 mg Coated tablet Oral use

336

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

United Kingdom

Ennogen Pharma Limited Unit G4, Riverside Industrial Estate Riverside Way Dartford DA1 5BS United Kingdom

Ibuprofen IBULAR TABLETS 400 MG

400 mg Coated tablet Oral use

United Kingdom

Fannin (UK) Limited 42-46 Booth Drive Park Farm South Wellingborough NN8 6GT United Kingdom

Ibuprofen FANNIN (UK) IBUPROFEN ORAL SUSPENSION 100MG/5ML

100 mg Oral suspension Oral use

United Kingdom

Fourrts (UK) Pharmacare Limited Chaul End Lane 30 Luton, Bedfordshire LU4 8EZ United Kingdom

Ibuprofen FOURRTS UK PHARMAC IBUPROFEN TABLETS 200MG

200 mg Coated tablet Oral use

United Kingdom

Fourrts (UK) Pharmacare Limited First Floor 2 Victoria Road Harpenden Hertfordshire AL5 4EA United Kingdom

Ibuprofen FOURRTS UK PHARMAC IBUPROFEN TABLETS 200MG

200 mg Film-coated tablet Oral use

337

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

United Kingdom

Fourrts (UK) Pharmacare Limited First Floor 2 Victoria Road Harpenden Hertfordshire AL5 4EA United Kingdom

Ibuprofen FOURRTS UK PHARMAC IBUPROFEN TABLETS 200MG

200 mg Film-coated tablet Oral use

United Kingdom

Fourrts (UK) Pharmacare Limited First Floor 2 Victoria Road Harpenden Hertfordshire AL5 4EA United Kingdom

Ibuprofen FOURRTS UK PHARMAC IBUPROFEN TABLETS 400MG

400 mg Film-coated tablet Oral use

United Kingdom

Fourrts (UK) Pharmacare Limited Chaul End Lane 30 Luton, Bedfordshire LU4 8EZ United Kingdom

Ibuprofen FOURRTS UK PHARMAC IBUPROFEN TABLETS 600MG

600 mg Film-coated tablet Oral use

United Kingdom

Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

Ibuprofen GALPHARM HEALTHCARE IBUPROFEN TABLETS 200MG

200 mg Coated tablet Oral use

338

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

United Kingdom

Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

Ibuprofen GALPHARM HEALTHCARE IBUPROFEN TABLETS 200MG

200 mg Coated tablet ORAL USE

United Kingdom

Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

Ibuprofen GALPHARM HEALTHCARE IBUPROFEN ORAL SUSPENSION 100MG/5ML

20 mg/ml Oral suspension Oral use

United Kingdom

Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

Ibuprofen GALPHARM IBUPROFEN TABLETS 400MG

400 mg Coated tablet Oral use

339

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

United Kingdom

Galpharm Healthcare Limited EX33 2DL Wrafton Braunton Devon United Kingdom

Ibuprofen JUNIOR IBUPROFEN SUSPENSION 100MG/5ML

20 mg/ml Oral suspension Oral use

United Kingdom

Galpharm Healthcare Limited EX33 2DL Wrafton Braunton Devon United Kingdom

Ibuprofen GALPHARM HEALTHCARE IBUPROFEN SUSPENSION 100MG/5ML

20 mg/ml Oral suspension Oral use

United Kingdom

Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

Ibuprofen GALPHARM HEALTHCARE IBUPROFEN CAPSULES 300MG

300 mg Modified-release capsule

Oral use

United Kingdom

Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

Ibuprofen GALPHARM HEALTHCARE IBUPROFEN CAPSULES 200MG

200 mg Capsule Oral use

340

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

United Kingdom

Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

Ibuprofen GALPHARM HEALTHCARE IBUPROFEN CAPSULES 200MG

200 mg Capsule Oral use

United Kingdom

Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

Ibuprofen GALPHARM HEALTHCARE IBUPROFEN LONG LASTING CAPSULES 200MG

200 mg Modified-release capsule, hard

Oral use

United Kingdom

Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

Ibuprofen GALPHARM HEALTHCARE IBUPROFEN TABLETS 200 MG

200 mg Film-coated tablet Oral use

341

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

United Kingdom

Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire S75 3SP Dodworth Dodworth Bussiness Park United Kingdom

Ibuprofen GALPHARM IBUPROFEN TABLETS 400 MG

400 mg Film-coated tablet Oral use

United Kingdom

Generics UK Albany Gate Darkes Lane Potters Bar Hertfordshire EN6 1AG United Kingdom

Ibuprofen GENERICS UK IBUPROFEN TABLETS 200MG

200 mg Tablet Oral use

United Kingdom

Generics UK Albany Gate Darkes Lane Potters Bar Hertfordshire EN6 1AG United Kingdom

Ibuprofen GENERICS UK IBUPROFEN TABLETS 400MG

400 mg Tablet Oral use

United Kingdom

Generics UK Albany Gate Darkes Lane Potters Bar Hertfordshire EN6 1AG United Kingdom

Ibuprofen GENERICS UK IBUPROFEN TABLETS 600MG

600 mg Tablet Oral use

342

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

United Kingdom

Generics UK Albany Gate Darkes Lane Potters Bar Hertfordshire EN6 1AG United Kingdom

Ibuprofen lysine GENERICS UK MIGRAINE RELIEF TABLETS 342 MG

342 mg Film-coated tablet Oral use

United Kingdom

Horizon Pharma Gmbh Joseph Meyer Strasse 13-15 68167 Mannheim Germany

Ibuprofen DUEXIS TABLETS 800 mg Film-coated tablet Oral use

United Kingdom

Flamingo Pharma (UK) Limited 1st Floor, Kirkland House 11-15 Peterborough Road Harrow Middlesex HA1 2AX United Kingdom

Ibuprofen FLAMINGO PHARMA IBUPROFEN TABLETS 200MG

200 mg Coated tablet Oral use

United Kingdom

Flamingo Pharma (UK) Limited 1st Floor, Kirkland House 11-15 Peterborough Road Harrow Middlesex HA1 2AX United Kingdom

Ibuprofen FLAMINGO PHARMA IBUPROFEN TABLETS 400 MG

400 mg Coated tablet Oral use

343

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

United Kingdom

Flamingo Pharma (UK) Limited 1st Floor, Kirkland House 11-15 Peterborough Road Harrow Middlesex HA1 2AX United Kingdom

Ibuprofen FLAMINGO PHARMA IBUPROFEN TABLETS 200MG

200 mg Coated tablet Oral use

United Kingdom

M & A Pharmachem ltd Allenby Laboratories Wigan Road Westhoughton Bolton BL5 2AL United Kingdom

Ibuprofen M&A PHARMACHEM IBUPROFEN TABLETS BP 600MG

600 mg Tablet Oral use

United Kingdom

M & A Pharmachem ltd Allenby Laboratories Wigan Road Westhoughton Bolton BL5 2AL United Kingdom

Ibuprofen M&A PHARMACHEM IBUPROFEN TABLETS BP 400MG

400 mg Tablet Oral use

United Kingdom

Max Remedies Limited Stoney Gate House 2 Greenfield Road Holmfirth W Yorkshire HD9 2JT United Kingdom

Ibuprofen MAX REMEDIES IBUPROFEN TABLETS 200MG

200 mg Tablet Oral use

344

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

United Kingdom

Max Remedies Limited Stoney Gate House 2 Greenfield Road Holmfirth W Yorkshire HD9 2JT United Kingdom

Ibuprofen MAX REMEDIES IBUPROFEN TABLETS 400MG

400 mg Coated tablet Oral use

United Kingdom

MCNeil Products Limited Johnson & Johnson Ltd UK Regulatory Department Foundation Park Roxborough Maidenhead Berkshire SL6 3UG United Kingdom

Ibuprofen SUDAFED SINUS TABLETS PRESSURE & PAIN

200 mg Tablet Oral use

United Kingdom

Mercury Pharma Group Ltd No 1 Croydon 12-16 Addiscombe Road Croydon Surrey CR0 0XT United Kingdom

Ibuprofen FENBID 300 mg Modified-release capsule

Oral use

United Kingdom

Mercury Pharmaceuticals Ltd Capital House King William Street 85 London EC4N 7BL United Kingdom

Ibuprofen MERCURY PHARMS IBUPROFEN TABLETS BP 200MG

200 mg Coated tablet Oral use

345

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

United Kingdom

Mercury Pharmaceuticals Ltd Capital House King William Street 85 London EC4N 7BL United Kingdom

Ibuprofen MERCURY PHARMS IBUPROFEN TABLETS BP 400MG

400 mg Coated tablet Oral use

United Kingdom

Mercury Pharmaceuticals Ltd Capital House King William Street 85 London EC4N 7BL United Kingdom

Ibuprofen MERCURY PHARMS IBUPROFEN TABLETS BP 600MG

600 mg Coated tablet Oral use

United Kingdom

Mercury Pharmaceuticals Ltd Capital House King William Street 85 London EC4N 7BL United Kingdom

Ibuprofen MERCURY PHARMS IBUPROFEN TABLETS BP 200MG

200 mg Coated tablet Oral use

United Kingdom

Mercury Pharmaceuticals Ltd Capital House King William Street 85 London EC4N 7BL United Kingdom

Ibuprofen MERCURY PHARMS IBUPROFEN TABLETS BP 200MG

200 mg Coated tablet Oral use

United Kingdom

Omega Pharma Ltd 1st Floor Vauxhall Bridge Road 32 London SW1V 2SA United Kingdom

Ibuprofen HEDEX IBUPROFEN TABLETS 200MG

200 mg Coated tablet Oral use

346

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Member State (in EEA)

Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

United Kingdom

Omega Pharma Ltd 1st Floor Vauxhall Bridge Road 32 London SW1V 2SA United Kingdom

Ibuprofen SOLPADEINE MIGRAINE IBUPROFEN & CODEINE TABLETS

200 mg Film-coated tablet Oral use

United Kingdom

Orbis Consumer Products Limited Cunard Road Park Royal London NW10 6PN United Kingdom

Ibuprofen ORBIFEN COLD AND FLU ORAL SUSPENSION

100 mg Oral suspension Oral use

United Kingdom

Pfizer Consumer Healthcare Vanwall Road Maidenhead, Berkshire, SL6 4UB United Kingdom

Ibuprofen ANADIN JOINT PAIN TABLETS 200MG

200 mg Coated tablet Oral use

United Kingdom

Pfizer Consumer Healthcare Vanwall Road Maidenhead, Berkshire, SL6 4UB United Kingdom

Ibuprofen ANADIN IBUPROFEN TABLETS 200MG

200 mg Coated tablet Oral use

347

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

United Kingdom

Pfizer Consumer Healthcare Vanwall Road Maidenhead, Berkshire, SL6 4UB United Kingdom

Ibuprofen ADVIL TABLETS 400MG 400 mg Film-coated tablet Oral use

United Kingdom

Pfizer Consumer Healthcare Vanwall Road Maidenhead, Berkshire, SL6 4UB United Kingdom

Ibuprofen ADVIL LIQUIGEL CAPSULES 200MG

200 mg Capsule Oral use

United Kingdom

Pfizer Consumer Healthcare Vanwall Road Maidenhead, Berkshire, SL6 4UB United Kingdom

Ibuprofen ANADIN ULTRA CAPSULES 200MG

200 mg Capsule, soft Oral use

United Kingdom

Pfizer Consumer Healthcare Walton Oaks Dorking Road Tadworth, Surrey KT20 7NS United Kingdom

Ibuprofen ADVIL LIQUI-GEL CAPSULES 400MG

400 mg Capsule, soft Oral use

348

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

United Kingdom

Pfizer Consumer Healthcare Vanwall Road Maidenhead, Berkshire, SL6 4UB United Kingdom

Ibuprofen ANADIN ULTRA DOUBLE STRENGTH CAPSULES 400MG

400 mg Capsule, soft Oral use

United Kingdom

Pfizer Consumer Healthcare Vanwall Road Maidenhead, Berkshire, SL6 4UB United Kingdom

Ibuprofen ADVIL TABLETS 200MG 200 mg Effervescent tablet Oral use

United Kingdom

Pfizer Consumer Healthcare Vanwall Road Maidenhead, Berkshire, SL6 4UB United Kingdom

Ibuprofen ADVIL TABLETS 400MG 400 mg Effervescent tablet Oral use

United Kingdom

Pfizer Consumer Healthcare Vanwall Road Maidenhead, Berkshire, SL6 4UB United Kingdom

Ibuprofen ANADIN LIQUIFAST 200 MG EFFERVESCENT TABLETS

200 mg Effervescent tablet Oral use

349

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INN Invented name Strength Pharmaceutical form

Route of administration

United Kingdom

Pfizer Consumer Healthcare Vanwall Road Maidenhead, Berkshire, SL6 4UB United Kingdom

Ibuprofen ANADIN LIQUIFAST TABLETS 400MG

400 mg Effervescent tablet Oral use

United Kingdom

PHARMVIT Limited 177 Bilton Road Perivale Middlesex UB6 7HQ United Kingdom

Ibuprofen PHARMVIT IBUPROFEN TABLETS 200MG

200 mg Coated tablet Oral use

United Kingdom

PHARMVIT Limited 177 Bilton Road Perivale Middlesex UB6 7HQ United Kingdom

Ibuprofen PHARMVIT IBUPROFEN TABLETS 400MG

400 mg Coated tablet Oral use

United Kingdom

PHARMVIT Limited 177 Bilton Road Perivale Middlesex UB6 7HQ United Kingdom

Ibuprofen PHARMAVIT IBUPROFEN TABLETS 600MG

600 mg Coated tablet Oral use

United Kingdom

Pinewood Laboratories Limited Ballymacarbry, Clonmel Co Tipperary Ireland

Ibuprofen PINEWOOD LABS IBUPROFEN ORAL SUSPENSION 100MG/5ML

100 mg Oral suspension Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

United Kingdom

Pinewood Laboratories Limited Ballymacarbry, Clonmel Co Tipperary Ireland

Ibuprofen PINEWOOD LABS IBUPROFEN ORAL SUSPENSION 100MG/5ML

100 mg Oral suspension Oral use

United Kingdom

Pinewood Laboratories Limited Ballymacarbry, Clonmel Co Tipperary Ireland

Ibuprofen PINEWOOD LABS IBUPROFEN ORAL SUSPENSION 100MG/5ML

100 mg Oral suspension Oral use

United Kingdom

Pinewood Laboratories Limited Ballymacarbry, Clonmel Co Tipperary Ireland

Ibuprofen PINEWOOD LABS IBUPROFEN ORAL SUSPENSION 200MG/5ML

200 mg Oral suspension Oral use

United Kingdom

Pinewood Laboratories Limited Ballymacarbry, Clonmel Co Tipperary Ireland

Ibuprofen PINEWOOD LABS IBUPROFEN ORAL SUSPENSION 200MG/5ML

200 mg Oral suspension Oral use

United Kingdom

Pinewood Laboratories Limited Ballymacarbry, Clonmel Co Tipperary Ireland

Ibuprofen PINEWOOD LABS IBUPROFEN ORAL SUSPENSION 200MG/5ML

200 mg Oral suspension Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

United Kingdom

Procter & Gamble (Health & Beauty Care) Limited The Heights, Brooklands Weybridge, Surrey KT13 0XP United Kingdom

Ibuprofen PROCTER & GAMBLE H&BC IBUPROFEN + PSEUDOEPHEDRINE HYDROCHLORIDE TABLETS

200 mg Film-coated tablet Oral use

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

Ibuprofen NUROFEN EXPRESS 256 MG TABLETS

200 mg Tablet Oral use

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

Ibuprofen NUROFEN TABLETS 256MG

200 mg Tablet Oral use

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

Ibuprofen NUROFEN EXPRESS CAPLETS 256 MG

200 mg Tablet Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

Ibuprofen NUROFEN COLD AND FLU TABLETS

200 mg Coated tablet Oral use

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

Ibuprofen NUROFEN PLUS 200 mg Coated tablet Oral use

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd. Dansom Lane Hull HU8 7DS United Kingdom

Ibuprofen NUROFEN BACK PAIN SUSTAINED RELEASE CAPSULES 300MG

300 mg Modified-release capsule

Oral use

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

Ibuprofen lysine NUROFEN MIGRAINE PAIN

342 mg Film-coated tablet Oral use

353

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

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United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

Ibuprofen NUROFEN MELTLETS LEMON 200MG

200 mg Orodispersible tablet Oral use

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

Ibuprofen lysine NUROFEN MAXIMUM STRENGTH MIGRAINE PAIN CAPLETS 684MG

684 mg Tablet Oral use

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

Ibuprofen NUROFEN TABLETS 200MG

200 mg Coated tablet Oral use

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

Ibuprofen NUROFEN CAPLETS 200 MG

200 mg Coated tablet Oral use

354

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

Ibuprofen NUROFEN CAPLETS 200MG

200 mg Coated tablet Oral use

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

Ibuprofen NUROFEN TABLETS 200MG

200 mg Coated tablet Oral use

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

Ibuprofen NUROFEN EXPRESS CAPLETS 256MG

200 mg Tablet Oral use

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

Ibuprofen NUROFEN EXPRESS TABLETS 512MG

400 mg Tablet Oral use

355

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

Ibuprofen LEMSIP MAX ALL DAY COLD & FLU TABLETS

200 mg Tablet Oral use

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

Ibuprofen LEMSIP MAX ALL NIGHT COLD & FLU TABLETS

200 mg Tablet Oral use

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

Ibuprofen IBUPROFEN AND PARACETAMOL 200MG/500MG TABLETS

200 mg Film-coated tablet Oral use

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

IBUPROFEN LYSINATE

NUROFEN EXPRESS SOLUBLE ORAL POWDER 400MG

683,34 mg Powder for oral solution

Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

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United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

Ibuprofen NUROFEN CAPSULE 400 MG

400 mg Capsule, soft Oral use

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

IBUPROFEN LYSINATE

NUROFEN EXPRESS ORAL POWDER 400MG

683,34 mg Powder for oral solution

Oral use

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

Ibuprofen NUROFEN EXPRESS PERIOD PAIN CAPSULES 200MG

200 mg Capsule, soft Oral use

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

Ibuprofen RECKITT BENCKISER HEALTHCARE UK IBUPROFEN LIQUICAPS 200MG

200 mg Capsule, soft Oral use

357

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

Ibuprofen NUROMOL 200MG/500MG TABLETS

200 mg Film-coated tablet Oral use

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

Ibuprofen RECKITT BENCKISER IBUPROFEN CAPSULES 200MG

200 mg Capsule, soft Oral use

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

Ibuprofen NUROFEN EXPRESS LIQUID CAPSULES 400MG

400 mg Capsule, soft Oral use

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

Ibuprofen NUROFEN 200MG LIQUICAPS PHARMACY ONLY

200 mg Capsule, soft Oral use

358

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

Ibuprofen sodium NUROFEN EXPRESS 256 MG TABLETS

256 mg Tablet Oral use

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

Ibuprofen sodium NUROFEN EXPRESS CAPLETS 256MG

256 mg Tablet Oral use

United Kingdom

Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom

Ibuprofen sodium NUROFEN EXPRESS TABLETS 512MG

512 mg Tablet Oral use

United Kingdom

Relonchem Limited Cheshire House Gorsey Lane Widnes WA8 0RP United Kingdom

Ibuprofen RELONCHEM IBUPROFEN TABLETS 400MG

400 mg Film-coated tablet Oral use

359

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

United Kingdom

Relonchem Limited Cheshire House Gorsey Lane Widnes WA8 0RP United Kingdom

Ibuprofen RELONCHEM LIMITED IBUPROFEN TABLETS 200MG

200 mg Coated tablet Oral use

United Kingdom

Remedica Ltd. P.O. Box 51706 CY-3508 Limassol Cyprus

Ibuprofen REMEDICA IBUPROFEN TABLETS 200MG

200 mg Coated tablet Oral use

United Kingdom

Remedica Ltd. P.O. Box 51706 CY-3508 Limassol Cyprus

Ibuprofen REMEDICA IBUPROFEN TABLETS 400MG

400 mg Coated tablet Oral use

United Kingdom

Remedica Ltd. P.O. Box 51706 CY-3508 Limassol Cyprus

Ibuprofen REMEDICA IBUPROFEN TABLETS 400MG

400 mg Coated tablet Oral use

United Kingdom

Smithkline Beecham (SWG) Limited Beecham Group PLC 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom

Ibuprofen IBUPROFEN 200 MG FILM-COATED TABLETS

200 mg Coated tablet Oral use

360

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

United Kingdom

Special Concept Development (UK) Ltd Unit 1-7 Colonial Way Watford Hertfordshire WD24 4YR United Kingdom

Ibuprofen SPECIAL CONCEPT IBUPROFEN TABLETS BP 400MG

400 mg Coated tablet Oral use

United Kingdom

Special Concept Development (UK) Ltd Unit 1-7 Colonial Way Watford Hertfordshire WD24 4YR United Kingdom

Ibuprofen SPECIAL CONCEPT IBUPROFEN TABLETS 200MG

200 mg Coated tablet Oral use

United Kingdom

Special Concept Development (UK) Ltd Unit 1-7 Colonial Way Watford Hertfordshire WD24 4YR United Kingdom

Ibuprofen SPECIAL CONCEPT IBUPROFEN TABLETS 200MG

200 mg Coated tablet Oral use

United Kingdom

SSL International plc Wellcroft House Wellcroft Road Slough, Berkshire SL1 4AQ United Kingdom

Ibuprofen IBUPROFEN & CODEINE TABLETS 200MG/12.8MG

200 mg Tablet Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

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United Kingdom

Teva UK Limited Field House Station Approach Harlow Essex CM20 2FB United Kingdom

Ibuprofen GALPHARM IBUPROFEN TABLETS BP 200MG

200 mg Coated tablet Oral use

United Kingdom

Teva UK Limited Field House Station Approach Harlow Essex CM20 2FB United Kingdom

Ibuprofen IBUPROFEN TABLETS BP 400MG (APSIFEN-F)

400 mg Coated tablet Oral use

United Kingdom

Teva UK Limited Field House Station Approach Harlow Essex CM20 2FB United Kingdom

Ibuprofen TEVA UK IBUPROFEN TABLETS BP 400MG

400 mg Coated tablet Oral use

United Kingdom

Teva UK Limited Field House Station Approach Harlow Essex CM20 2FB United Kingdom

Ibuprofen TEVA UK IBUPROFEN TABLETS 600MG

600 mg Film-coated tablet Oral use

United Kingdom

The Boots Company PLC Nottingham Support Office D90 West First 17 Thane Road Nottingham NG90 5EF United Kingdom

Ibuprofen BOOTS IBUPROFEN CAPLETS 200 MG

200 mg Tablet Oral use

362

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

United Kingdom

The Boots Company PLC Nottingham Support Office D90 West First 17 Thane Road Nottingham NG90 5EF United Kingdom

Ibuprofen BOOTS IBUPROFEN CAPLETS 400MG

400 mg Tablet Oral use

United Kingdom

The Boots Company PLC Nottingham Support Office D90 West First 17 Thane Road Nottingham NG90 5EF United Kingdom

Ibuprofen BOOTS COLD & FLU RELIEF WITH IBUPROFEN TABLETS

200 mg Tablet Oral use

United Kingdom

The Boots Company PLC Nottingham Support Office D90 West First 17 Thane Road Nottingham NG90 5EF United Kingdom

Ibuprofen BOOTS IBUPROFEN AND CODEINE TABLETS

200 mg Film-coated tablet Oral use

United Kingdom

Thornton & Ross Ltd Linthwaite Huddersfield HD7 5QH United Kingdom

Ibuprofen CARE IBUPROFEN ORAL SUSPENSION

100 mg Oral suspension Oral use

United Kingdom

Vitabiotics Limited, 1 Apsley Way London NW2 7HF United Kingdom

Ibuprofen VITABIOTICS IBUPROFEN TABLETS 400MG

400 mg Coated tablet Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

United Kingdom

Vitabiotics Limited, 1 Apsley Way London NW2 7HF United Kingdom

Ibuprofen VITABIOTICS IBUPROFEN TABLETS 400MG

400 mg Coated tablet Oral use

United Kingdom

Waymade Plc Sovereign House Miles Gray Road Basildon, Essex SS14 3FR United Kingdom

Ibuprofen WAYMADE IBUPROFEN TABLETS 200MG

200 mg Coated tablet Oral use

United Kingdom

Waymade Plc Sovereign House Miles Gray Road Basildon, Essex SS14 3FR United Kingdom

Ibuprofen WAYMADE IBUPROFEN TABLETS 400MG

400 mg Coated tablet Oral use

United Kingdom

Waymade Plc Sovereign House Miles Gray Road Basildon, Essex SS14 3FR United Kingdom

Ibuprofen WAYMADE IBUPROFEN TABLETS 600MG

600 mg Film-coated tablet Oral use

United Kingdom

Waymade Plc Sovereign House Miles Gray Road Basildon, Essex SS14 3FR United Kingdom

Ibuprofen WAYMADE IBUPROFEN TABLETS BP 200MG

200 mg Coated tablet Oral use

364

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

United Kingdom

Waymade Plc Sovereign House Miles Gray Road Basildon, Essex SS14 3FR United Kingdom

Ibuprofen WAYMADE IBUPROFEN TABLETS BP 400MG

400 mg Coated tablet Oral use

United Kingdom

Waymade Plc Sovereign House Miles Gray Road Basildon, Essex SS14 3FR United Kingdom

Ibuprofen WAYMADE IBUPROFEN TABLETS BP 600MG

600 mg Coated tablet Oral use

United Kingdom

Winthrop Pharmaceuticals Uk Limited One Onslow Street Guildford, Surrey GU1 4YS United Kingdom

Ibuprofen IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE TABLETS 200 MG/5 MG

200 mg Film-coated tablet Oral use

United Kingdom

Wockhardt UK Limited Ash Road North Wrexham Industrial Estate Wrexham, LL13 9UF United Kingdom

Ibuprofen WOCKHARDT UK IBUPROFEN TABLETS 200MG

200 mg Coated tablet Oral use

United Kingdom

Wockhardt UK Limited Ash Road North Wrexham Industrial Estate Wrexham, LL13 9UF United Kingdom

Ibuprofen WOCKHARDT UK MAXIMUM STRENGTH IBUPROFEN TABLETS 400MG

400 mg Coated tablet Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

United Kingdom

Wockhardt UK Limited Ash Road North Wrexham Industrial Estate Wrexham, LL13 9UF United Kingdom

Ibuprofen WOCKHARDT UK IBUPROFEN CAPLETS 200MG

200 mg Coated tablet Oral use

United Kingdom

Wockhardt UK Limited Ash Road North Wrexham Industrial Estate Wrexham, LL13 9UF United Kingdom

Ibuprofen WOCKHARDT UK EXTRA STRENGTH IBUPROFEN CAPLETS 400MG

400 mg Coated tablet Oral use

United Kingdom

Wockhardt UK Limited Ash Road North Wrexham Industrial Estate Wrexham, LL13 9UF United Kingdom

Ibuprofen WOCKHARDT UK IBUPROFEN TABLETS 200MG

200 mg Coated tablet Oral use

United Kingdom

Wockhardt UK Limited Ash Road North Wrexham Industrial Estate Wrexham, LL13 9UF United Kingdom

Ibuprofen WOCKHARDT UK IBUPROFEN TABLETS 200MG

200 mg Coated tablet Oral use

United Kingdom

Wockhardt UK Limited Ash Road North Wrexham Industrial Estate Wrexham, LL13 9UF United Kingdom

Ibuprofen WOCKHARDT UK EXTRA STRENGTH IBUPROFEN TABLETS 400MG

400 mg Coated tablet Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

United Kingdom

Wockhardt UK Limited Ash Road North Wrexham Industrial Estate Wrexham, LL13 9UF United Kingdom

Ibuprofen WOCKHARDT UK IBUPROFEN CAPLETS 200MG

200 mg Coated tablet Oral use

United Kingdom

Wrafton Laboratories Limited Exeter Road Wrafton Braunton Devon EX33 2DL United Kingdom

Ibuprofen lysine WRAFTON LABS MIGRAINE RELIEF TABLETS 342MG

342 mg Tablet Oral use

United Kingdom

Wrafton Laboratories Limited Exeter Road Wrafton Braunton Devon EX33 2DL United Kingdom

Ibuprofen lysine WRAFTON LABS IBUPROFEN PERRIGO FILM-COATED TABLETS 200MG

342 mg Film-coated tablet Oral use

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Marketing authorisation holder

INN Invented name Strength Pharmaceutical form

Route of administration

United Kingdom

Wrafton Laboratories Limited Exeter Road Wrafton Braunton Devon EX33 2DL United Kingdom

Ibuprofen lysine WRAFTON LABS IBUPROFEN PERRIGO TABLETS 400 MG

684 mg Film-coated tablet Oral use

United Kingdom

Medley Pharma Limited Unit 2A, Olympic Way, Sefton Business Park Bootle, Liverpool L30 1RD United Kingdom

Ibuprofen Medley Pharma Ibuprofen Tablets 200mg

200 mg Coated tablet Oral use

United Kingdom

Medley Pharma Limited Unit 2A, Olympic Way, Sefton Business Park Bootle, Liverpool L30 1RD United Kingdom

Ibuprofen Medley Pharma Ibuprofen Tablets 400mg

400 mg Coated tablet Oral use

United Kingdom

Gebro Pharma GmbH A- 6391 Fieberbrunn Austria

Dexibuprofen SERACTIL TABLETS 300MG

300 mg Film-coated tablet Oral use

United Kingdom

Gebro Pharma GmbH A- 6391 Fieberbrunn Austria

Dexibuprofen SERACTIL TABLETS 400MG

400 mg Film-coated tablet Oral use

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Annex II

Scientific conclusions and grounds for variation to the terms of the marketing authorisations

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Scientific conclusions and grounds for variation to the terms of the marketing authorisations

Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID) used for the reduction of inflammation, pain and fever. It is commonly used and is widely available without prescription, typically at doses ≤1200mg daily, to treat a range of conditions including pain, fever, rheumatic conditions and minor ailments. Ibuprofen is also prescribed for the chronic management of rheumatic conditions such as osteoarthritis (typically doses higher than 1200mg daily).

Ibuprofen contains equal quantities of R(-)-ibuprofen and S(+)-ibuprofen. As it is the S(+)-enantiomer which confers the anti-inflammatory and analgesic activity and not the R(-)-enantiomer, dexibuprofen which contains only S(+)-ibuprofen is also available as a medicinal product. The approved indications for dexibuprofen are similar to those for ibuprofen.

The cardiovascular (CV) risk of NSAIDs, including ibuprofen, has been kept under close review over the past years. A previous review conducted in 2006 concluded that NSAIDs as a class were associated with an increased risk of arterial thrombotic events, although the risk was considered to be higher for selective cyclooxygenase-2 (COX-2) inhibitors (also known as coxibs). Clinical trial data at that time suggested that ibuprofen at a high dose (2400 mg daily) may be associated with an increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Overall, epidemiological studies did not suggest that ibuprofen at low doses (≤1200 mg daily) is associated with an increased risk of arterial thrombotic events, in particular myocardial infarction (MI)1.

Another evaluation, conducted by the CHMP in 2012, considered all available published evidence to date from epidemiological studies and also meta-analyses of clinical trials and observational studies as well as the results of the ‘safety of non-steroidal anti-inflammatory drugs’ (SOS) research project funded by the European Commission under the Seventh Framework Programme. Based on the available evidence, the review concluded, in line with previous conclusions, that ibuprofen at a high dose may be associated with an increased risk of arterial thrombotic events, and that ibuprofen at low doses is not consistently associated with an increased risk of arterial thrombotic events2.

Since the 2012 review, the Coxib and traditional NSAID Triallists’ (CNT) collaborative group published results from a large meta-analysis of more than 600 randomised clinical trials. The results suggested that the cardiovascular risk with high dose ibuprofen (2400mg) may also be similar to COX-2 inhibitors3.

In light of the above, and given the widespread use of ibuprofen, UK considered that it is in the interest of the Union to refer ibuprofen and dexibuprofen containing products for systemic use to the PRAC and request, that it gives its recommendation under Article 31 of Directive 2001/83/EC, on whether the new evidence on the risk of thrombotic events when used at high doses, doses at or above 2400mg per day, in adults and new evidence on interaction with low-dose acetylsalicylic acid require any updates to the advice to healthcare professionals and patients including warnings or contraindications as expressed in the current ibuprofen product information, or whether any other regulatory measure would be needed.

1 Information on the review conducted in 2006 can be found at http://www.ema.europa.eu/docs/en_GB/document_library/Report/2010/01/WC500054344.pdf 2 Information on the review conducted in 2012 can be found at http://www.ema.europa.eu/docs/en_GB/document_library/Report/2012/11/WC500134717.pdf 3 Vascular and upper gastrointestinal effects of non-steroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomised trials. Coxib and traditional NSAID Trialists' (CNT) Collaboration. The Lancet - 30 May 2013

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The scope of the procedure included medicinal products containing (racemic) ibuprofen and dexibuprofen (S(+)-ibuprofen). Although there is very little data available regarding the arterial thrombotic risks of dexibuprofen or regarding a possible interaction between dexibuprofen and low-dose acetylsalicylic acid, it is reasonable to assume that dexibuprofen shares similar risks with (racemic) ibuprofen, hence its inclusion in the scope of this referral procedure.

The scope of the referral procedure included only systemic formulations (e.g. oral formulations, rectal preparations) but did not include products authorised for use solely in children or topical preparations intended for local effects with low systemic absorption (e.g. creams, gels, sprays, vaginal and ophthalmic preparations).

In the results of the CNT Collaboration’s network meta-analysis which partly triggered this review, high doses of ibuprofen (2400mg/day) significantly increased major coronary events (MCE) (MI or coronary heart disease (CHD) death) but not major vascular events (MVE) (non-fatal MI, coronary death, MI or CHD death, non-fatal stroke, stroke death, any stroke, and other vascular death). The adjusted rate ratio for ibuprofen vs placebo for MCE and MVE were 2.22 (1.10-4.48) and 1.44 (0.89-2.33), respectively. In the coxib vs ibuprofen comparisons the rate ratios favoured coxibs for both MCE and MVE (i.e. slightly increased risk with ibuprofen vs coxibs group) but these were not statistically significant.

In the initial PRAC consideration of the CNT collaboration network meta-analyses, a number of important questions regarding statistical methodology were raised which were considered to limit the interpretation of the results in particular for the traditional NSAIDs (tNSAIDs), including ibuprofen. Consequently, further clarifications from the CNT Collaboration were requested around the use of indirect comparisons for tNSAIDs, the handling of zero event trials and shorter than average follow-up for ibuprofen trials that could bias the results upwards for ibuprofen.

The CNT Collaboration’s responses to the PRAC questions confirmed that zero event trials and possible unequal randomisation are unlikely to have introduced any significant bias to the results of the network meta-analysis for ibuprofen. The responses also confirmed that there is very little randomised evidence directly comparing ibuprofen to placebo and that the results of the network meta-analysis are primarily derived from studies that directly compared coxibs with ibuprofen. The PRAC was of the view that this makes it difficult to judge the size of any biases which may have been introduced by any differences in study population and study duration.

The CNT Collaboration’s responses also confirmed that the trials that compared ibuprofen with placebo were shorter in duration than the trials that compared ibuprofen with coxibs and thus there is the possibility that including the trials that compared ibuprofen with placebo in the network meta-analysis could inflate the treatment effect. The data provided by ibuprofen vs placebo trials are too limited to draw any conclusions on the risk.

Given the outstanding uncertainties regarding the size of potential biases in the network meta-analysis and the paucity of information available directly comparing ibuprofen with placebo, the PRAC was of the view that any conclusions on the magnitude of the CV risk of ibuprofen drawn from this meta-analysis should be based on the results of studies that compared ibuprofen with coxibs and not the indirect comparisons derived from the network meta-analysis.

Overall, the PRAC was of the opinion that the data from the coxib vs ibuprofen trials indicate that the CV risks of high dose ibuprofen may be similar to that for coxibs.

Several other data sources informed the recommendation of the PRAC, including available data from previous reviews, clinical studies, published literature as well as data submitted by marketing authorisation holders (MAHs) of medicinal products containing ibuprofen or dexibuprofen.

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The PRAC was of the opinion that clinical trial data suggest that high daily doses of ibuprofen (2400mg/day) are associated with an increased risk of cardiovascular events (MI, stroke), which may be similar to that observed with coxibs or diclofenac. The review of the updated epidemiological data confirms the findings of previous EU reviews and does not suggest that ibuprofen at low doses (≤1200mg/day) is associated with an increased risk of cardiovascular events.

The PRAC noted that there are no or limited data on the arterial thrombotic risk of ibuprofen at doses between 1200mg and 2400mg/day and so it cannot be determined exactly how the risk changes over this dosage range. However the PRAC considered that it is likely that there is a dose-dependent increase in risk with increasing doses between 1200mg and 2400mg/day.

The effect of ibuprofen treatment duration on cardiovascular risk has not been extensively studied and is therefore uncertain.

Cardiovascular risk may be higher in patients with cardiovascular disease, and high ibuprofen doses should be avoided in this population. Similarly, high daily doses should not be recommended to patients with risk factors for cardiovascular disease.

The PRAC considered that, in general terms, the current product information of ibuprofen-containing products already contains meaningful information regarding cardiovascular risks. However, the information about the use of high ibuprofen doses in certain populations with pre-existing cardiovascular disease and/or risk factors for arterial thrombotic events merits further clarification and thus updates should be made to section 4.4 and 4.8.

Although no specific data about cardiovascular risk of dexibuprofen are available, a similar cardiovascular risk to that of high-dose of ibuprofen is expected when dexibuprofen is used at equipotent doses. The data submitted by the MAHs widely supported the definition of dexibuprofen high dose as 50% of the high dose of ibuprofen. The PRAC concluded that dexibuprofen product information should be amended in the same way as ibuprofen product information.

Regarding the interaction between ibuprofen and acetylsalicylic acid, the PRAC was of the opinion that new pharmacodynamic and epidemiological data investigating a possible interaction between ibuprofen and acetylsalicylic acid are consistent with the conclusions of the previous EU-wide review of this issue – that whilst pharmacodynamic studies show that ibuprofen inhibits the antiplatelet effect of acetylsalicylic acid when it is administered concurrently, the clinical implications of such an interaction are still uncertain. The PRAC further concluded that the possibility that regular, long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid cannot be excluded.

The PRAC was of the view that updates should be made to section 4.5 and 5.1 to reflect current data on the potential clinical effect of the pharmacodynamic interaction when ibuprofen is taken with acetylsalicylic acid.

There are limited available data on a potential interaction between dexibuprofen and acetylsalicylic acid. However, the results of a single pharmacodynamic study submitted by one of the MAHs in response to the PRAC questions suggest that dexibuprofen also reduces the antiplatelet effect of acetylsalicylic acid ex vivo. The PRAC was of the view that any update to the ibuprofen product information should also be applied to the product information for dexibuprofen, taking into consideration any dexibuprofen specific details, e.g. equipotent dose.

The recommendation for update of the product information should be applicable to all medicinal products containing ibuprofen and dexibuprofen, regardless of maximum recommended daily dose.

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Having noted all of the above, the PRAC concluded that the benefit-risk balance for ibuprofen and dexibuprofen containing medicinal products (systemic formulations) remains favourable subject to the agreed changes to the product information.

Overall conclusion and grounds for the variation to the terms of the marketing authorisations

Whereas,

• The PRAC considered the procedure under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data, for ibuprofen- and dexibuprofen-containing medicinal products (systemic formulations).

• The PRAC considered the totality of the data available in relation to the cardiovascular risk of ibuprofen- and dexibuprofen-containing medicinal products and in relation to the potential interaction between ibuprofen/dexibuprofen and acetylsalicylic acid, acknowledging the conclusions from previous reviews, the submissions by marketing authorisation holders, and additional data from independent researchers.

• The PRAC considered that with regard to the arterial thrombotic risks of ibuprofen, the data available to date from randomised clinical trials, observational studies and individual epidemiological studies, including meta-analysis thereof, supports that ibuprofen at high doses (2400mg or above per day) is associated with an increased risk of arterial thrombotic events. It was observed that this risk may be similar to that of selective COX-2 inhibitors. The available data do not suggest that ibuprofen at low doses (equal to or below 1200mg per day) is associated with an increased risk of arterial thrombotic events.

• The PRAC considered that although no specific data about the cardiovascular risk of dexibuprofen are available, a similar cardiovascular risk to that of high-dose of ibuprofen is expected when dexibuprofen is used at equipotent doses.

• The PRAC considered that with regard to the interaction between ibuprofen/dexibuprofen and acetylsalicylic acid the pharmacodynamic studies available to date show that ibuprofen/dexibuprofen inhibit the antiplatelet effect of acetylsalicylic acid when it is administered concurrently. The epidemiological data available to date, however, do not demonstrate a clinically significant interaction but the possibility that regular, long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid cannot be excluded.

• The PRAC considered that in general terms, the current product information of ibuprofen- and dexibuprofen-containing products already contains meaningful information regarding cardiovascular risks and pharmacodynamic interaction with acetylsalicylic acid. However, the PRAC concluded that information about the risks associated with the use of high doses of ibuprofen/dexibuprofen in certain populations with pre-existing cardiovascular disease and/or risk factors for arterial thrombotic events merits further clarification, as well as some additional information on the potential clinical effect of the pharmacodynamic interaction when taken with acetylsalicylic acid.

The PRAC concluded that the benefit-risk balance for ibuprofen- and dexibuprofen-containing medicinal products (systemic formulations) remains favourable subject to the agreed changes to the product information.

Therefore, the PRAC recommended the variation to the terms of the marketing authorisation for all medicinal products referred to in Annex I and for which the amendments of the relevant sections of the

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summary of product characteristics and package leaflet are set out in Annex III of the PRAC recommendation.

CMDh agreement The CMDh, having considered the PRAC recommendation dated 10 April 2015 pursuant to Article 107k(1) and (2) of Directive 2001/83/EC agrees with the overall scientific conclusions by the PRAC and to the variation to the terms of the marketing authorisations of medicinal products containing ibuprofen or dexibuprofen (systemic formulations) as set out in Annex III.

The timetable for the implementation of the agreement is set out in Annex IV.

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Annex III

Amendments to relevant sections of the summary of product characteristics and package leaflet

Note:

These amendments to the relevant sections of the Summary of Product Characteristics and Package Leaflet are the outcome of the referral procedure.

The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.

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For all ibuprofen-containing products

A. Summary of Products Characteristics

Section 4.2 - Posology and method of administration

[The section should be amended to reflect the following wording]

[…]

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).

[…]

Section 4.3 - Contraindications

[The section should be amended to reflect the following wording]

[…]

Severe heart failure (NYHA Class IV)

[…]

Section 4.4 - Special warnings and precautions for use

[The section should be amended to reflect the following wording]

[…]

Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400 mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low dose ibuprofen (e.g. ≤ 1200 mg/day) is associated with an increased risk of arterial thrombotic events.

Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with ibuprofen after careful consideration and high doses (2400 mg/day) should be avoided.

Careful consideration should also be exercised before initiating long-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), particularly if high doses of ibuprofen (2400 mg/day) are required.

[…]

Section 4.5 - Interactions with other medicinal products and other forms of interaction

[The section should be amended to reflect the following wording]

[…]

Acetylsalicylic acid

Concomitant administration of ibuprofen and acetylsalicylic acid is not generally recommended because of the potential of increased adverse effects.

Experimental data suggest that ibuprofen may competitively inhibit the effect of low dose acetylsalicylic acid on platelet aggregation when they are dosed concomitantly. Although there are uncertainties regarding extrapolation of these data to the clinical situation, the possibility that regular, long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid

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cannot be excluded. No clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 5.1).

[…]

Section 4.8 - Undesirable effects

[The section should be amended to reflect the following wording]

[…]

Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400 mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4).

[…]

Section 5.1 - Pharmacodynamic properties

[The section should be amended to reflect the following wording]

[…]

Experimental data suggest that ibuprofen may competitively inhibit the effect of low dose acetylsalicylic acid on platelet aggregation when they are dosed concomitantly. Some pharmacodynamic studies show that when single doses of ibuprofen 400 mg were taken within 8 h before or within 30 min after immediate release acetylsalicylic acid dosing (81 mg), a decreased effect of acetylsalicylic acid on the formation of thromboxane or platelet aggregation occurred. Although there are uncertainties regarding extrapolation of these data to the clinical situation, the possibility that regular, long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid cannot be excluded. No clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 4.5).

[…]

B. Package Leaflet

Section 2 - What you need to know before you take [Invented name]

[…]

Warnings and precautions

[The section should be amended to reflect the following wording]

[…]

Anti-inflammatory/pain-killer medicines like ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.

You should discuss your treatment with your doctor or pharmacist before taking [Invented name] if you:

- have heart problems including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs of feet due to narrow or blocked arteries), or any kind of stroke (including ‘mini-stroke’ or transient ischaemic attack “TIA”).

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- have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker.

[…] Other medicines and [Invented name] [The section should be amended to reflect the following wording]

[…]

[Invented name] may affect or be affected by some other medicines. For example:

[…]

- medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine)

- medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan)

[…]

Some other medicines may also affect or be affected by the treatment of [Invented name]. You should therefore always seek the advice of your doctor or pharmacist before you use [Invented name] with other medicines.

[…]

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For all dexibuprofen-containing products

A. Summary of Products Characteristics

Section 4.2 - Posology and method of administration

[The section should be amended to reflect the following wording]

[…]

The dosage should be adjusted to the severity of the disorder and the complaints of the patient. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).

[…]

Section 4.3 - Contraindications

[The section should be amended to reflect the following wording]

[…]

Severe heart failure (NYHA Class IV)

[…]

Section 4.4 - Special warnings and precautions for use

[The section should be amended to reflect the following wording]

[…]

Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400 mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low dose ibuprofen (e.g. ≤ 1200 mg/day) is associated with an increased risk of arterial thrombotic events. Although there are limited data on the arterial thrombotic risk of dexibuprofen, it is reasonable to assume that the risk with high dose dexibuprofen (1200 mg/day) would be similar to that associated with high dose ibuprofen (2400 mg/day).

Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with dexibuprofen after careful consideration and high doses (1200 mg/day) should be avoided.

Careful consideration should also be exercised before initiating long-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), particularly if high doses of dexibuprofen (1200 mg/day) are required.

[…]

Section 4.5 - Interactions with other medicinal products and other forms of interaction

[The section should be amended to reflect the following wording (if sub-sections exist this wording should be included in the relevant sub-section, e.g. concomitant use not recommended)]

[…]

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Acetylsalicylic acid

Concomitant administration of dexibuprofen and acetylsalicylic acid is not generally recommended because of the potential of increased adverse effects.

Experimental data suggest that ibuprofen may competitively inhibit the effect of low dose acetylsalicylic acid on platelet aggregation when they are dosed concomitantly. Although there are uncertainties regarding extrapolation of these data to the clinical situation, the possibility that regular, long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid cannot be excluded. No clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 5.1). Whilst there are no data available for dexibuprofen, it is reasonable to assume that a similar interaction may exist between dexibuprofen (= S(+)-ibuprofen) (which is the pharmacologically active enantiomer of ibuprofen) and low-dose acetylsalicylic acid.

[…]

Section 4.8 - Undesirable effects

[The section should be amended to reflect the following wording]

[…]

Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400 mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4). Although there are limited data on the arterial thrombotic risk of dexibuprofen, it is reasonable to assume that the risk with high dose dexibuprofen (1200 mg/day) would be similar to that associated with high dose ibuprofen (2400 mg/day).

[…]

Section 5.1 - Pharmacodynamic properties

[The section should be amended to reflect the following wording]

[…]

Experimental data suggest that ibuprofen may competitively inhibit the effect of low dose acetylsalicylic acid on platelet aggregation when they are dosed concomitantly. Some pharmacodynamic studies show that when single doses of ibuprofen 400 mg were taken within 8 h before or within 30 min after immediate release acetylsalicylic acid dosing (81 mg), a decreased effect of acetylsalicylic acid on the formation of thromboxane or platelet aggregation occurred. Although there are uncertainties regarding extrapolation of these data to the clinical situation, the possibility that regular, long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid cannot be excluded. No clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 4.5). Whilst there are no data available for dexibuprofen, it is reasonable to assume that a similar interaction may exist between dexibuprofen (= S(+)-ibuprofen) (the pharmacologically active enantiomer of ibuprofen) and low-dose acetylsalicylic acid.

[…]

B. Package Leaflet

Section 2 - What you need to know before you take [Invented name]

[…]

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Warnings and precautions

[The section should be amended to reflect the following wording]

[…]

Anti-inflammatory/pain-killer medicines like dexibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.

You should discuss your treatment with your doctor or pharmacist before taking [Invented name] if you:

- have heart problems including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs of feet due to narrow or blocked arteries), or any kind of stroke (including ‘mini-stroke’ or transient ischaemic attack “TIA”).

- have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker.

[…] Other medicines and [Invented name] [The section should be amended to reflect the following wording]

[…]

[Invented name] may affect or be affected by some other medicines. For example:

[…]

- medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine)

- medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan)

[…]

Some other medicines may also affect or be affected by the treatment of [Invented name]. You should therefore always seek the advice of your doctor or pharmacist before you use [Invented name] with other medicines.

[…]

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Annex IV

Timetable for the implementation of the agreement

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Timetable for the implementation of the agreement

Adoption of CMDh agreement:

May 2015 CMDh meeting

Transmission to National Competent Authorities of the translations of the annexes to the agreement:

17 June 2015

Implementation of the agreement by the Member States (submission of the variation type IB by the Marketing Authorisation Holder):

16 October 2015

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