Active substance: acetylcysteine Procedure no.: PSUSA ......List of nationally authorised medicinal...

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Official address Domenico Scarlattilaan 6 1083 HS Amsterdam The Netherlands An agency of the European Union Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 © European Medicines Agency, 2019. Reproduction is authorised provided the source is acknowledged. 16 May 2019 EMA/280811/2019 Human Medicines Evaluation Division List of nationally authorised medicinal products Active substance: acetylcysteine Procedure no.: PSUSA/00000034/201809

Transcript of Active substance: acetylcysteine Procedure no.: PSUSA ......List of nationally authorised medicinal...

Page 1: Active substance: acetylcysteine Procedure no.: PSUSA ......List of nationally authorised medicinal products EMA/280811/2019 Page 2/21 Product Name (in authorisation country) MRP/DCP

Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands

An agency of the European Union Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000

© European Medicines Agency, 2019. Reproduction is authorised provided the source is acknowledged.

16 May 2019 EMA/280811/2019 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance: acetylcysteine

Procedure no.: PSUSA/00000034/201809

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List of nationally authorised medicinal products EMA/280811/2019 Page 2/21

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Fluimucil 200 mg bruistabletten not available RVG 09988 ZAMBON NEDERLAND B.V. NL HIDONAC 5g/25 ml, solution injectable pour perfusion

not available 3400955583912 ZAMBON FRANCE S.A. FR

HIDONAC 5 g/25 ml, solution injectable pour perfusion

not available 34009 560 355 95 ZAMBON FRANCE S.A. FR

Pulmosal 200mg Comprimidos efervescentes

not available 5519285 LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A.

PT

Mucomyst 200 mg poretabletti not available 10154 MEDA OY FI Mucomyst 200 mg brustablett not available 10154 MEDA OY FI Hidonac antídoto 200 mg/ml concentrado para solución para perfusión

not available 58931 ZAMBON, S.A.U. ES

EXOMUC 200 mg, granulés pour solution buvable en sachet

not available 34009 327 178 0 4 BOUCHARA RECORDATI FR

EXOMUC 200 mg, granulés pour solution buvable en sachet

not available 34009 339 450 2 2 BOUCHARA RECORDATI FR

EXOMUC 200 mg, granulés pour solution buvable en sachet

not available 34009 363 850 7 8 BOUCHARA RECORDATI FR

EXOMUC 200 mg, granulés pour solution buvable en sachet

not available 34009 363 851 3 9 BOUCHARA RECORDATI FR

EXOMUC 200 mg, granulés pour solution buvable en sachet

not available 0173839 BOUCHARA RECORDATI LU

ACC 100 NEO, šumivé tablety not available 52/016/07-C HEXAL AG CZ Acetylcysteïn Sandoz 100 mg granulés pour solution buvable

DE/H/3623/001 2014090211 SANDOZ N.V. LU

ACC 100 mg/ml, süstelahus not available 368101 SANDOZ PHARMACEUTICALS D.D.

EE

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Fluimucil N 200 mg Granulat zur Herstellung einer Lösung zum Einnehmen

not available 8595.01.00 ZAMBON GMBH DE

Fluimucil long 600 mg Brausetabletten

not available 8753.00.00 ZAMBON GMBH DE

Fluimucil 200 mg Brausetabletten

not available 8595.01.01 ZAMBON GMBH DE

Fluimucil 10% Injektionslösung und Lösung für einen Vernebler

not available 11577.00.00 ZAMBON GMBH DE

Fluimucil Kindersaft 2% Lösung zum Einnehmen

not available 29683.00.00 ZAMBON GMBH DE

Fluimucil Hustenlöser akut 600 mg Brausetabletten

not available 32364.02.00 ZAMBON GMBH DE

Fluimucil Antidot 20% Konzentrat zur Herstellung einer Infusionslösung

not available 8709.00.00 ZAMBON GMBH DE

Lysomucil 600 mg comprimés not available 2013060188 ZAMBON NV LU FLUIMUCIL 600 mg compresse effervescenti

not available 020582262 ZAMBON ITALIA S.R.L. IT

FLUIMUCIL 600 mg granulato per soluzione orale

not available 020582274 ZAMBON ITALIA S.R.L. IT

FLUIMUCIL MUCOLITICO 600 mg, compresse effervescenti

not available 034936171 ZAMBON ITALIA S.R.L. IT

FLUIMUCIL MUCOLITICO 200 mg, compresse effervescenti

not available 034936132 ZAMBON ITALIA S.R.L. IT

FLUIMUCIL MUCOLITICO 200 mg, compresse effervescenti

not available 034936144 ZAMBON ITALIA S.R.L. IT

Lysomucil 4% sirop not available BE 260933 ZAMBON NV BE

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Lysomucil 4% siroop not available BE260933 ZAMBON NV BE Lysomucil 4% sirop not available 2004090036 ZAMBON NV LU Lysomucil10%, solution not available BE027894 ZAMBON NV BE Lysomucil 10%, oplossing not available BE027894 ZAMBON NV BE Lysomucil10%, solution not available 2004098407 ZAMBON NV LU Lysomucil 20%, solution not available BE027885 ZAMBON NV BE Lysomucil 20%, oplossing not available BE027885 ZAMBON NV BE Lysomucil 20%, solution not available 2004098408 ZAMBON NV LU Lysomucil 200 mg comprimés effervescents

not available BE125081 ZAMBON NV BE

Lysomucil 200 mg bruistabletten not available BE125081 ZAMBON NV BE Lysomucil 200 mg comprimés effervescents

not available 2003047227 ZAMBON NV LU

Lysomucil 200 mg capsules, hard

not available BE128387 ZAMBON NV BE

Lysomucil 200 mg gélules not available BE128387 ZAMBON NV BE Lysomucil 200 mg gélules not available 2006018341 ZAMBON NV LU Lysomucil 200 mg granulés pour solution buvable

not available BE161384 ZAMBON NV BE

Lysomucil 200 mg granulaat voor drank

not available BE161384 ZAMBON NV BE

Lysomucil 200 mg granulés pour solution buvable

not available 2003047226 ZAMBON NV LU

Lysomucil 600 mg comprimés effervescents

not available BE150202 ZAMBON NV BE

Lysomucil 600 mg bruistabletten not available BE150202 ZAMBON NV BE Lysomucil 600 mg comprimés not available 2006058568 ZAMBON NV LU

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

effervescents Lysomucil 600 mg granulés pour solution buvable

not available BE 196262 ZAMBON NV BE

Lysomucil 600 mg granulaat voor drank

not available BE 196262 ZAMBON NV BE

Lysomucil 600 mg granulés pour solution buvable

not available 2006058569 ZAMBON NV LU

Lysomucil 600 mg comprimés not available BE279422 ZAMBON NV BE Lysomucil 600 mg tabletten not available BE279422 ZAMBON NV BE Lysomucil 2% sirop not available BE220525 ZAMBON NV BE Lysomucil 2% siroop not available BE220525 ZAMBON NV BE Lysomucil Junior 2% sirop not available 2006018340 ZAMBON NV LU Lysomucil Pastille 200 mg comprimés à sucer

not available 2006018342 ZAMBON NV LU

Lysomucil Pastille 200 mg comprimés à sucer

not available BE225251 ZAMBON NV BE

Lysomucil Pastille 200 mg zuigtabletten

not available BE225251 ZAMBON NV BE

Fluimucil 300 mg/3 ml Solução injectável

not available 2196087 ZAMBON - PRODUTOS FARMACÊUTICOS, LDA.

PT

FLUIMUCIL 2%, 20mg/ml, solução oral

not available 5427216 ZAMBON - PRODUTOS FARMACÊUTICOS, LDA.

PT

FLUIMUCIL 2%, 20mg/ml, solução oral

not available 3311180 ZAMBON - PRODUTOS FARMACÊUTICOS, LDA.

PT

Fluimucil 200 mg/ml Concentrado para solução para perfusão

not available 5626072 ZAMBON - PRODUTOS FARMACÊUTICOS, LDA.

PT

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

FLUIMUCIL 200 mg, comprimidos dispersíveis

not available 3486487 ZAMBON - PRODUTOS FARMACÊUTICOS, LDA.

PT

FLUIMUCIL 200 mg, comprimidos dispersíveis

not available 3486586 ZAMBON - PRODUTOS FARMACÊUTICOS, LDA.

PT

Fluimucil 200 mg Granulado para solução oral

not available 2195980 ZAMBON - PRODUTOS FARMACÊUTICOS, LDA.

PT

FLUIMUCIL 4% 40 mg/ml solução oral

not available 5269188 ZAMBON - PRODUTOS FARMACÊUTICOS, LDA.

PT

FLUIMUCIL 4% 40 mg/ml solução oral

not available 5269287 ZAMBON - PRODUTOS FARMACÊUTICOS, LDA.

PT

Fluimucil 600 Comprimido efervescente

not available 2195782 ZAMBON - PRODUTOS FARMACÊUTICOS, LDA.

PT

FLUIMUCIL 300 mg/3 ml soluzione per nebulizzatore

not available 020582021 ZAMBON ITALIA S.R.L. IT

FLUIMUCIL 300 mg/3 ml soluzione per nebulizzatore

not available 020582235 ZAMBON ITALIA S.R.L. IT

FLUIMUCIL 300 mg/3 ml Soluzione iniettabile e per nebulizzatore e per instillazione endotracheobronchiale

not available 020582019 ZAMBON ITALIA S.R.L. IT

FLUIMUCIL 300 mg/3 ml Soluzione iniettabile e per nebulizzatore e per instillazione endotracheobronchiale

not available 020582033 ZAMBON ITALIA S.R.L. IT

FLUIMUCIL 600 mg compresse effervescenti

not available 020582209 ZAMBON ITALIA S.R.L. IT

FLUIMUCIL 600 mg granulato per soluzione orale

not available 020582173 ZAMBON ITALIA S.R.L. IT

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

FLUIMUCIL MUCOLITICO 600 mg granulato per soluzione orale senza zucchero

not available 034936169 ZAMBON ITALIA S.R.L. IT

FLUIMUCIL 600 mg granulato per soluzione orale

not available 020582223 ZAMBON ITALIA S.R.L. IT

FLUIMUCIL MUCOLITICO 600 mg/15 ml sciroppo

not available 034936157 ZAMBON ITALIA S.R.L. IT

FLUIMUCIL MUCOLITICO 100 mg, granulato per soluzione orale

not available 034936017 ZAMBON ITALIA S.R.L. IT

FLUIMUCIL MUCOLITICO 100 mg granulato per soluzione orale senza zucchero

not available 034936043 ZAMBON ITALIA S.R.L. IT

FLUIMUCIL MUCOLITICO 100 mg/5 ml sciroppo

not available 034936082 ZAMBON ITALIA S.R.L. IT

FLUIMUCIL MUCOLITICO 100 mg/5 ml sciroppo

not available 034936118 ZAMBON ITALIA S.R.L. IT

FLUIMUCIL MUCOLITICO 200 mg, compresse orosolubili

not available 034936094 ZAMBON ITALIA S.R.L. IT

FLUIMUCIL MUCOLITICO 200 mg, compresse orosolubili

not available 034936120 ZAMBON ITALIA S.R.L. IT

FLUIMUCIL MUCOLITICO 200 mg, granulato per soluzione orale

not available 034936031 ZAMBON ITALIA S.R.L. IT

FLUIMUCIL MUCOLITICO 200 mg, granulato per soluzione orale senza zucchero

not available 034936106 ZAMBON ITALIA S.R.L. IT

HIDONAC 5 g/25 ml soluzione not available 032268017 ZAMBON ITALIA S.R.L. IT

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

per infusione Fluimucil szirup not available OGYI-T-5351/09 ZAMBON S.P.A. HU Fluimucil 100 granule pentru soluţie orală 100 mg

not available 2274/2009/01 ZAMBON S.P.A. RO

Fluimucil JUNIOR 100 mg granulátum

not available OGYI-T-5351/01 ZAMBON S.P.A. HU

Fluimucil JUNIOR 100 mg granulátum

not available OGYI-T-5351/02 ZAMBON S.P.A. HU

Fluimucil JUNIOR 100 mg granulátum

not available OGYI-T-5351/03 ZAMBON S.P.A. HU

Fluimucil 100 mg/ml oldatos injekció

not available OGYI-T-5351/10 ZAMBON S.P.A. HU

FLUIMUCIL 20 mg/ml pediatric, soluție orala

not available 7715/2015/01 ZAMBON S.P.A. RO

Fluimucil 200 granule pentru soluţie orală 200mg

not available 2275/2009/01 ZAMBON S.P.A. RO

Fluimucil 200 mg granules for oral solution

not available PA 1441/1/1 ZAMBON S.P.A. IE

Fluimucil 200 mg granulátum not available OGYI-T-5351/04 ZAMBON S.P.A. HU Fluimucil 200 mg granulátum not available OGYI-T-5351/05 ZAMBON S.P.A. HU Fluimucil 200 mg granulátum not available OGYI-T-5351/06 ZAMBON S.P.A. HU FLUIMUCIL 300 mg/3 ml soluţie injectabilă/soluţie pentru inhalat prin nebulizator/soluţie pentru instilaţie endotraheobronşică

not available 7716/2015/01 ZAMBON S.P.A. RO

Fluimucil 600 comprimate efervescente 600 mg

not available 2276/2009/01 ZAMBON S.P.A. RO

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Fluimucil FORTE 600 mg pezsgőtabletta

not available OGYI-T-5351/07 ZAMBON S.P.A. HU

Fluimucil FORTE 600 mg pezsgőtabletta

not available OGYI-T-5351/08 ZAMBON S.P.A. HU

Fluimucil antidote 20% koncentrátum infúzióhoz

not available OGYI-T- 5351/11 ZAMBON S.P.A. HU

HIDONAC 5 g/25 ml, soluţie perfuzabilă

not available 7728/2015/01 ZAMBON S.P.A. RO

FLUIMUCIL 300 mg/3 ml soluzione per nebulizzatore

not available 020582298 ZAMBON ITALIA S.R.L. IT

FLUIMUCIL 300 mg/3 ml soluzione per nebulizzatore

not available 020582300 ZAMBON ITALIA S.R.L. IT

ФЛУИМУЦИЛ 200 mg гранули за перорален разтвор

not available 20060669 ZAMBON S.P.A. BG

Mucomyst, inhalationsvæske til nebulisator, opløsning

not available 4896 MEDA AS DK

BRUNAC eye-drops not available 024593016 BRUSCHETTINI S.R.L IT Acetylcysteïn Sandoz 600 mg granulaat voor drank

DE/H/3623/003 BE449671 SANDOZ N.V. BE

MUCODRILL 600 mg SANS SUCRE, comprimé effervescent édulcoré au sucralose

NL/H/2843/001 34009 278 260 4 7 ALPEX PHARMA (UK) LTD FR

MUCODRILL 600 mg SANS SUCRE, comprimé effervescent édulcoré au sucralose

NL/H/2843/001 34009 278 261 0 8 ALPEX PHARMA (UK) LTD FR

MUCODRILL 600 mg SANS SUCRE, comprimé effervescent édulcoré au sucralose

NL/H/2843/001 34009 278 262 7 6 ALPEX PHARMA (UK) LTD FR

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

MUCODRILL 600 mg SANS SUCRE, comprimé effervescent édulcoré au sucralose

NL/H/2843/001 34009 278 263 3 7 ALPEX PHARMA (UK) LTD FR

MUCODRILL 600 mg SANS SUCRE, comprimé effervescent édulcoré au sucralose

NL/H/2843/001 34009 586 439 5 8 ALPEX PHARMA (UK) LTD FR

MUCODRILL 600 mg SANS SUCRE, comprimé effervescent édulcoré au sucralose

NL/H/2843/001 34009 586 440 3 0 ALPEX PHARMA (UK) LTD FR

MUCODRILL 600 mg SANS SUCRE, comprimé effervescent édulcoré au sucralose

NL/H/2843/001 34009 586 442 6 9 ALPEX PHARMA (UK) LTD FR

MUCODRILL 600 mg SANS SUCRE, comprimé effervescent édulcoré au sucralose

NL/H/2843/001 34009 586 443 2 0 ALPEX PHARMA (UK) LTD FR

MUCODRILL 600 mg SANS SUCRE, comprimé effervescent édulcoré au sucralose

NL/H/2843/001 34009 586 444 9 8 ALPEX PHARMA (UK) LTD FR

MUCODRILL 600 mg SANS SUCRE, comprimé effervescent édulcoré au sucralose

NL/H/2843/001 34009 586 445 5 9 ALPEX PHARMA (UK) LTD FR

EURONAC 5 POUR CENT, collyre en solution

not available 336477-7 DOLIAGE LABORATOIRES FR

Fluimucil 200 mg/ml concentraat voor oplossing voor infusie

not available RVG 10903 ZAMBON NEDERLAND B.V. NL

Fluimucil 20 mg/ml Drank not available RVG 20870 ZAMBON NEDERLAND B.V. NL Acetylcysteïne Imphos 600 mg Imphos bruistabletten

not available RVG 20882 ZAMBON NEDERLAND B.V. NL

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Mucolysin, pulver til oral opløsning

not available 51689 SANDOZ A/S DK

FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 2 % ADULTES SANS SUCRE, solution buvable édulcorée à la saccharine sodique, au cyclamate de sodium et au sucralose

not available 3400935392541 ZAMBON FRANCE S.A. FR

FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 2 % ADULTES SANS SUCRE, solution buvable édulcorée à la saccharine sodique, au cyclamate de sodium et au sucralose

not available 34009 353 926 0 2 ZAMBON FRANCE S.A. FR

FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 2 % ADULTES SANS SUCRE, solution buvable édulcorée à la saccharine sodique, au cyclamate de sodium et au sucralose

not available 34009 353 927 7 0 ZAMBON FRANCE S.A. FR

FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 2 % ADULTES SANS SUCRE, solution buvable édulcorée à la saccharine sodique, au cyclamate de sodium et au sucralose

not available 34009 353 928 3 1 ZAMBON FRANCE S.A. FR

TREBON-N® Pd. or. sus. -100 mg/5ml

not available 66199 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL

GR

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

LABORATORIES S.A. TREBON-N® Pd. or. sus. 200 mg/5ml

not available 66200 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.

GR

TREBON-N® Ef. tablets 600 mg/tab

not available 89132 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.

GR

TREBON-N® not available 13418 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.

GR

TREBON-N® not available 13420 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.

GR

TREBON-N® not available 35997 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.

GR

TREBON-N® Gr. or. sd. 600 mg/sachet

not available 22102 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.

CY

Fluimucil 100 mg/ml, oplossing voor inhalatiedamp

not available RVG 06742 ZAMBON NEDERLAND B.V. NL

MUCOMYST 200 mg, poudre pour solution buvable en sachet

not available 34009 329 165 3 5 UPSA SAS FR

MUCOMYST 200 mg, poudre pour solution buvable en sachet

not available 34009 326 883 2 6 UPSA SAS FR

MUCOMYST 200 mg, poudre pour solution buvable en sachet

not available 34009 343 346 1 0 UPSA SAS FR

MUCOMYST 200 mg, poudre not available 34009 340 651 8 7 UPSA SAS FR

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

pour solution buvable en sachet MUCOMYSTENDO 1 g/5 ml, solution pour instillation endotrachéobronchique en ampoule

not available 34009 380 263 9 9 BRISTOL-MYERS SQUIBB FR

Fluimucil 200 mg orodispergeerbare tabletten

not available RVG 25408 ZAMBON NEDERLAND B.V. NL

Fluimucil 200 mg granulaat voor drank

not available RVG 07289 ZAMBON NEDERLAND B.V. NL

EXOMUC 200 mg, granulés pour solution buvable en sachet

not available 34009 327 178 0 4 BOUCHARA RECORDATI FR

EXOMUC 200 mg, granulés pour solution buvable en sachet

not available 34009 339 450 2 2 BOUCHARA RECORDATI FR

EXOMUC 200 mg, granulés pour solution buvable en sachet

not available 34009 363 850 7 8 BOUCHARA RECORDATI FR

EXOMUC 200 mg, granulés pour solution buvable en sachet

not available 34009 363 851 3 9 BOUCHARA RECORDATI FR

EXOMUC 200 mg, granulés pour solution buvable en sachet

not available 0173839 BOUCHARA RECORDATI LU

Fluimucil Forte 600 mg comprimidos efervescentes

not available 62663 ZAMBON, S.A.U. ES

Flumil 100 mg/ml solución inyectable

not available 41474 ZAMBON, S.A.U. ES

FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 2 % ENFANTS SANS SUCRE, solution buvable édulcorée à la saccharine sodique, au cyclamate de

not available 3400935319333 ZAMBON FRANCE S.A. FR

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

sodium et au sucralose FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 2 % ENFANTS SANS SUCRE, solution buvable édulcorée à la saccharine sodique, au cyclamate de sodium et au sucralose

not available 34009 353 195 6 2 ZAMBON FRANCE S.A. FR

FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 2 % ENFANTS SANS SUCRE, solution buvable édulcorée à la saccharine sodique, au cyclamate de sodium et au sucralose

not available 34009 353 196 2 3 ZAMBON FRANCE S.A. FR

FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 200 mg ADULTES SANS SUCRE, granulés pour solution buvable en sachet édulcorés à l’aspartam et au sorbitol

not available 3400935068521 ZAMBON FRANCE S.A. FR

FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 200 mg ADULTES SANS SUCRE, granulés pour solution buvable en sachet édulcorés à l’aspartam et au sorbitol

not available 3400935068699 ZAMBON FRANCE S.A. FR

FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 200 mg ADULTES SANS SUCRE, granulés

not available 3400935068750 ZAMBON FRANCE S.A. FR

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List of nationally authorised medicinal products EMA/280811/2019 Page 15/21

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

pour solution buvable en sachet édulcorés à l’aspartam et au sorbitol Mucomyst 200 mg/ml inhalasjonsvæske til nebulisator, oppløsning

not available 5107 MEDA AS NO

Flumil Infantil 100 mg granulado para solución oral

not available 62664 ZAMBON, S.A.U. ES

ФЛУИМУЦИЛ 100 mg гранули за перорален разтвор

not available 20060668 ZAMBON S.P.A. BG

Fluimucil 600 mg tabletten not available RVG 109369 ZAMBON NEDERLAND B.V. NL Granon, brusetabletter DK/H/2352/002 50408 TAKEDA PHARMA A/S DK Granon 600 mg brusetabletter DK/H/2352/002 15-10523 TAKEDA AS NO Fluimucil 40 mg/ml solución oral not available 65532 ZAMBON, S.A.U. ES ACC LONG 600 mg šumivé tablety

not available 52/973/95-C HEXAL AG CZ

ACC 200 NEO, šumivé tablety not available 52/017/07-C HEXAL AG CZ Acetylcysteine Mylan 600 mg granulés pour solution buvable (sans sucre)

not available BE216352 MYLAN BVBA/SPRL BE

Acetylcysteine Mylan 600 mg Granulat zur Herstellung einer Lösung zum Einnehmen

not available BE216352 MYLAN BVBA/SPRL BE

Acetylcysteine Mylan 600 mg granulaat voor drank (zonder suiker)

not available BE216352 MYLAN BVBA/SPRL BE

Acetylcysteine Mylan 600 mg granulés pour solution buvable

not available 2001050028 MYLAN BVBA/SPRL LU

Page 16: Active substance: acetylcysteine Procedure no.: PSUSA ......List of nationally authorised medicinal products EMA/280811/2019 Page 2/21 Product Name (in authorisation country) MRP/DCP

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

(sans sucre) ILUBE 5% w/v eye drops, solution

not available PL 47069/0002 RAYNER PHARMACEUTICALS UK

Mucomyst 200 mg brusetabletter

not available 7141 MEDA AS NO

Mucomyst, brusetabletter not available 10802 MEDA AS DK Fluimucil 200 mg granulado para solución oral

not available 62665 ZAMBON, S.A.U. ES

Bronchocil 200 mg Lösung zum Einnehmen

not available BE179636 MENARINI BENELUX N.V./S.A. BE

Bronchocil 200 mg solution buvable

not available BE179636 MENARINI BENELUX N.V./S.A. BE

Bronchocil 200 mg drank not available BE179636 MENARINI BENELUX N.V./S.A. BE Bronchocil 200 mg granulés pour solution buvable

not available BE179627 MENARINI BENELUX N.V./S.A. BE

Bronchocil 200 mg granulaat voor drank

not available BE179627 MENARINI BENELUX N.V./S.A. BE

Bronchocil 200 mg Granulat zur Herstellung einer Lösung zum Einnehmen

not available BE179627 MENARINI BENELUX N.V./S.A. BE

Bronchocil 600 mg granulés pour solution buvable

not available BE208512 MENARINI BENELUX N.V./S.A. BE

Bronchocil 600 mg Granulat zur Herstellung einer Lösung zum Einnehmen

not available BE208512 MENARINI BENELUX N.V./S.A. BE

Bronchocil 600 mg granulaat voor drank

not available BE208512 MENARINI BENELUX N.V./S.A. BE

Page 17: Active substance: acetylcysteine Procedure no.: PSUSA ......List of nationally authorised medicinal products EMA/280811/2019 Page 2/21 Product Name (in authorisation country) MRP/DCP

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Flumil 20 mg/ml solución oral not available 63512 ZAMBON, S.A.U. ES ACC 200, tvrdé tobolky not available 52/974/95-C HEXAL AG CZ FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 200 mg SANS SUCRE, granulés pour solution buvable en sachet édulcorés à l’aspartam et au sorbitol

not available 3400933182113 ZAMBON FRANCE S.A. FR

FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 200 mg SANS SUCRE, granulés pour solution buvable en sachet édulcorés à l’aspartam et au sorbitol

not available 3400934318122 ZAMBON FRANCE S.A. FR

FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 200 mg SANS SUCRE, granulés pour solution buvable en sachet édulcorés à l’aspartam et au sorbitol

not available 3400932373697 ZAMBON FRANCE S.A. FR

ACC INJEKT 100 mg/ml injekční roztok a roztok k rozprašování

not available 52/507/96-C HEXAL AG CZ

Acétylcystéine Alpex 600 mg, granulés pour solution buvable

NL/H/2843/003 34009 301 260 4 2 ALPEX PHARMA (UK) LTD FR

Acétylcystéine Alpex 600 mg, granulés pour solution buvable

NL/H/2843/003 34009 301 260 5 9 ALPEX PHARMA (UK) LTD FR

Acétylcystéine Alpex 600 mg, granulés pour solution buvable

NL/H/2843/003 34009 301 260 6 6 ALPEX PHARMA (UK) LTD FR

Acétylcystéine Alpex 600 mg, granulés pour solution buvable

NL/H/2843/003 34009 301 260 7 3 ALPEX PHARMA (UK) LTD FR

ACC® Saft, 20 mg/ml Lösung DE/H/3624/001 87763.00.00 HEXAL AG DE

Page 18: Active substance: acetylcysteine Procedure no.: PSUSA ......List of nationally authorised medicinal products EMA/280811/2019 Page 2/21 Product Name (in authorisation country) MRP/DCP

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

zum Einnehmen Husten ACC Hexal akut 20 mg/ml - Lösung zum Einnehmen

DE/H/3624/001 135466 HEXAL PHARMA GMBH AT

Fluimucil 40 mg/ml drank forte not available RVG 29360 ZAMBON NEDERLAND B.V. NL ФЛУИМУЦИЛ 600 mg ефервесцентни таблетки

not available 20060667 ZAMBON S.P.A. BG

TIROCULAR 4% collirio, soluzione

not available 028165025 AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO - A.C.R.A.F. S.P.A.

IT

Solmucol Prášek a rozpouštědlo pro sirup

not available 52/278/96-C IBSA SLOVAKIA S.R.O. CZ

LYSOX 200 mg solution buvable not available BE159214 MENARINI BENELUX N.V./S.A. BE LYSOX 200 mg Lösung zum Einnehmen

not available BE159214 MENARINI BENELUX N.V./S.A. BE

LYSOX 20 mg/ml sirop not available BE214751 MENARINI BENELUX N.V./S.A. BE LYSOX junior 100 mg Granulat zur Herstellung einer Lösung zum Einnehmen

not available BE166643 MENARINI BENELUX N.V./S.A. BE

LYSOX 20 mg/ml sirop not available BE214767 MENARINI BENELUX N.V./S.A. BE LYSOX 20 mg/ml Sirup not available BE214751 MENARINI BENELUX N.V./S.A. BE LYSOX 100 mg comprimés à sucer

not available BE166634 MENARINI BENELUX N.V./S.A. BE

LYSOX 20 mg/ml Sirup not available BE214767 MENARINI BENELUX N.V./S.A. BE LYSOX junior 100 mg granulés pour solution buvable

not available BE166643 MENARINI BENELUX N.V./S.A. BE

LYSOX 400 mg Granulat zur Herstellung einer Lösung zum

not available BE166661 MENARINI BENELUX N.V./S.A. BE

Page 19: Active substance: acetylcysteine Procedure no.: PSUSA ......List of nationally authorised medicinal products EMA/280811/2019 Page 2/21 Product Name (in authorisation country) MRP/DCP

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

Einnehmen LYSOX 600 mg Granulat zur Herstellung einer Lösung zum Einnehmen

not available BE191265 MENARINI BENELUX N.V./S.A. BE

LYSOX 100 mg Lutschtabletten not available BE166634 MENARINI BENELUX N.V./S.A. BE LYSOX 200 mg granulés pour solution buvable

not available BE166652 MENARINI BENELUX N.V./S.A. BE

LYSOX 200 mg Granulat zur Herstellung einer Lösung zum Einnehmen

not available BE166652 MENARINI BENELUX N.V./S.A. BE

LYSOX 600 mg granulés pour solution buvable

not available BE191265 MENARINI BENELUX N.V./S.A. BE

LYSOX 400 mg granulés pour solution buvable

not available BE166661 MENARINI BENELUX N.V./S.A. BE

SOLMUCOL 100 100 mg granule pro perorální roztok

not available 52/533/92-A/C IBSA SLOVAKIA S.R.O. CZ

SOLMUCOL 200, 200 mg granule pro perorální roztok

not available 52/533/92-B/C IBSA SLOVAKIA S.R.O. CZ

Solmucol® 100 mg not available 52/0533/92-S IBSA SLOVAKIA S.R.O. SK Solmucol® 200 mg not available 52/0533/92-S IBSA SLOVAKIA S.R.O. SK Solmucol® 400 mg not available 52/0533/92-S IBSA SLOVAKIA S.R.O. SK Solmucol® 600 mg not available 52/0533/92-S IBSA SLOVAKIA S.R.O. SK SOLMUCOL 100 mg Pastilky not available 52/055/92-S/C IBSA SLOVAKIA S.R.O. CZ Solmucol® pastilky 100 mg not available 52/0055/92-S IBSA SLOVAKIA S.R.O. SK Solmucol 90 prášok na sirup not available 52/0615/94-S IBSA SLOVAKIA S.R.O. SK Solmucol 180 prášok na sirup not available 52/0270/17-S IBSA SLOVAKIA S.R.O. SK SOLMUCOL 600 mg granulato not available 028311076 IBSA FARMACEUTICI ITALIA IT

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

per soluzione orale SOLMUCOL 600 mg granulato per soluzione orale

not available 028311102 IBSA FARMACEUTICI ITALIA IT

ACETYLCYSTEINE GENEVRIER 200 mg/8ml, poudre et sirop pour solution buvable

not available 34009 353 202 2 3 LABORATOIRES GENEVRIER FR

GENAC 5 POUR CENT, collyre not available 34009 336 478 3 4 LABORATOIRES GENEVRIER FR SOLMUCOL 100 mg, granulés pour solution buvable en sachet-dose

not available 34009 331 566 1 9 LABORATOIRES GENEVRIER FR

SOLMUCOL 100 mg, granulés pour solution buvable en sachet-dose

not available 34009 332 196 3 5 LABORATOIRES GENEVRIER FR

SOLMUCOL 200 mg, granulés pour solution buvable en sachet-dose

not available 34009 331 568 4 8 LABORATOIRES GENEVRIER FR

SOLMUCOL 200 mg, granulés pour solution buvable en sachet-dose

not available 34009 377 164 3 7 LABORATOIRES GENEVRIER FR

SOLMUCOL® not available 19527 IBSA FARMACEUTICI ITALIA CY LYSOX 400 mg granulaat voor drank

not available BE166661 MENARINI BENELUX N.V./S.A. BE

LYSOX 200 mg solution buvable not available 0115/03/05/7252 MENARINI BENELUX N.V./S.A. LU LYSOX Junior 100 mg granulaat voor drank

not available BE166643 MENARINI BENELUX N.V./S.A. BE

LYSOX 200 mg granulés pour solution buvable

not available 0115/06018336 MENARINI BENELUX N.V./S.A. LU

LYSOX 100 mg zuigtabletten not available BE166634 MENARINI BENELUX N.V./S.A. BE

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number MAH of product in the member state

Member State where product is authorised

LYSOX 200 mg drank not available BE159214 MENARINI BENELUX N.V./S.A. BE LYSOX 600 mg granulés pour solution buvable

not available 0115/03/05/7253 MENARINI BENELUX N.V./S.A. LU

LYSOX 100 mg comprimés à sucer

not available 0115/06018339 MENARINI BENELUX N.V./S.A. LU

LYSOX 400 mg granulés pour solution buvable

not available 0115/06018337 MENARINI BENELUX N.V./S.A. LU

LYSOX 600 mg granulaat voor drank

not available BE191265 MENARINI BENELUX N.V./S.A. BE

LYSOX 200 mg granulaat voor drank

not available BE166652 MENARINI BENELUX N.V./S.A. BE

LYSOX junior 100 mg granulés pour solution buvable

not available 0115/06018335 MENARINI BENELUX N.V./S.A. LU

LYSOX 20 mg/ml siroop not available BE214767 MENARINI BENELUX N.V./S.A. BE LYSOX 20 mg/ml siroop not available BE214751 MENARINI BENELUX N.V./S.A. BE LYSOX 20 mg/ml sirop not available 0115/06018338 MENARINI BENELUX N.V./S.A. LU ILUBE 5% w/v Eye Drops, Solution

not available PA 2161/002/001 RAYNER PHARMACEUTICALS IE

Fluimucil 600 mg bruistabletten not available RVG 12151 ZAMBON NEDERLAND B.V. NL ACC LONG 600 mg šumivé tablety

not available 52/973/95-C HEXAL AG CZ