Ibuprofen Art 31 - CMDh agreement av... · Ibuprofen Actavis 200 mg . 200 mg : Coated tablet . Oral...
Transcript of Ibuprofen Art 31 - CMDh agreement av... · Ibuprofen Actavis 200 mg . 200 mg : Coated tablet . Oral...
Annex I
List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the
Member States
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
2
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
3
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
4
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
5
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
6
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
7
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
8
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
9
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
10
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
11
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
12
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 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
13
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
14
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
15
Member State (in EEA)
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
16
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
17
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 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
18
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
19
Member State (in EEA)
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
20
Member State (in EEA)
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
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
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
Member State (in EEA)
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
Member State (in EEA)
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
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
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
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
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
Member State (in EEA)
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
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
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
Member State (in EEA)
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
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
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
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
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
Member State (in EEA)
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
42
Member State (in EEA)
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
Member State (in EEA)
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
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
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
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
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
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
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
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
Member State (in EEA)
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
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
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
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
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
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
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
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
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-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
Member State (in EEA)
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
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
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 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
63
Member State (in EEA)
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
64
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 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
65
Member State (in EEA)
Marketing authorisation holder
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
66
Member State (in EEA)
Marketing authorisation holder
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
Member State (in EEA)
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
68
Member State (in EEA)
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
Member State (in EEA)
Marketing authorisation holder
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
Member State (in EEA)
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
Member State (in EEA)
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
72
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
76
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
Marketing authorisation holder
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
80
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
84
Member State (in EEA)
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
Member State (in EEA)
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 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
86
Member State (in EEA)
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
87
Member State (in EEA)
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
Member State (in EEA)
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
89
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
96
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
99
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
102
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
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
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 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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
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
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
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
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
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
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
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
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
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
124
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
125
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
126
Member State (in EEA)
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 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
127
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
128
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
129
Member State (in EEA)
Marketing authorisation holder
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
130
Member State (in EEA)
Marketing authorisation holder
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
131
Member State (in EEA)
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
132
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
133
Member State (in EEA)
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
134
Member State (in EEA)
Marketing authorisation holder
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
135
Member State (in EEA)
Marketing authorisation holder
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
136
Member State (in EEA)
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
137
Member State (in EEA)
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 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
138
Member State (in EEA)
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
139
Member State (in EEA)
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 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
140
Member State (in EEA)
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
141
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
142
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
143
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
144
Member State (in EEA)
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 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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
156
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
160
Member State (in EEA)
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
161
Member State (in EEA)
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
162
Member State (in EEA)
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
163
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
164
Member State (in EEA)
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
165
Member State (in EEA)
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
Member State (in EEA)
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
167
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
168
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
169
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
170
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
171
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
172
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
173
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
174
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
175
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
176
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
177
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
178
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
179
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
180
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
181
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
182
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
183
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
184
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
185
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
186
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
187
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
188
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
189
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
190
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
191
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
Member State (in EEA)
Marketing authorisation holder
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
Member State (in EEA)
Marketing authorisation holder
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
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
Member State (in EEA)
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
199
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
Member State (in EEA)
Marketing authorisation holder
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
204
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
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 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
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
210
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 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
211
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
212
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
213
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
214
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
215
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
216
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
217
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
218
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
219
Member State (in EEA)
Marketing authorisation holder
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
220
Member State (in EEA)
Marketing authorisation holder
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
Member State (in EEA)
Marketing authorisation holder
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
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
223
Member State (in EEA)
Marketing authorisation holder
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
224
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
225
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
226
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
227
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
228
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
229
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
231
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
232
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
233
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
234
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
235
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
236
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
237
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
238
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
239
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
240
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
241
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
242
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
243
Member State (in EEA)
Marketing authorisation holder
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
244
Member State (in EEA)
Marketing authorisation holder
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
245
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
246
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
247
Member State (in EEA)
Marketing authorisation holder
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
248
Member State (in EEA)
Marketing authorisation holder
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
249
Member State (in EEA)
Marketing authorisation holder
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 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
250
Member State (in EEA)
Marketing authorisation holder
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
251
Member State (in EEA)
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
252
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
253
Member State (in EEA)
Marketing authorisation holder
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
254
Member State (in EEA)
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
255
Member State (in EEA)
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
256
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
257
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
260
Member State (in EEA)
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
261
Member State (in EEA)
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
Member State (in EEA)
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
263
Member State (in EEA)
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
Member State (in EEA)
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
265
Member State (in EEA)
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
266
Member State (in EEA)
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
267
Member State (in EEA)
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
268
Member State (in EEA)
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
Member State (in EEA)
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
270
Member State (in EEA)
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
271
Member State (in EEA)
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 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
272
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
273
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
274
Member State (in EEA)
Marketing authorisation holder
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 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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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 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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
Marketing authorisation holder
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
Marketing authorisation holder
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
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
Member State (in EEA)
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
Member State (in EEA)
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
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
Member State (in EEA)
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
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
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 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
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
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
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
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
Member State (in EEA)
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
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
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
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
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
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
Member State (in EEA)
Marketing authorisation holder
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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 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
350
Member State (in EEA)
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
351
Member State (in EEA)
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
352
Member State (in EEA)
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
Member State (in EEA)
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 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
Member State (in EEA)
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
Member State (in EEA)
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
356
Member State (in EEA)
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 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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
Member State (in EEA)
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
361
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
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
Member State (in EEA)
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
363
Member State (in EEA)
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
Member State (in EEA)
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
365
Member State (in EEA)
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
366
Member State (in EEA)
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
367
Member State (in EEA)
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
368
Member State (in EEA)
Marketing authorisation holder
INN Invented name Strength Pharmaceutical form
Route of administration
369
Annex II
Scientific conclusions and grounds for variation to the terms of the marketing authorisations
370
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.
372
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.
373
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
374
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.
376
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
377
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”).
378
- 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.
[…]
379
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)]
[…]
380
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]
[…]
381
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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