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...
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
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
List of nationally authorised medicinal products EMA/280811/2019 Page 3/21
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 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
List of nationally authorised medicinal products EMA/280811/2019 Page 4/21
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
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
List of nationally authorised medicinal products EMA/280811/2019 Page 5/21
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
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
List of nationally authorised medicinal products EMA/280811/2019 Page 6/21
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, 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
List of nationally authorised medicinal products EMA/280811/2019 Page 7/21
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 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
List of nationally authorised medicinal products EMA/280811/2019 Page 8/21
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
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
List of nationally authorised medicinal products EMA/280811/2019 Page 9/21
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 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
List of nationally authorised medicinal products EMA/280811/2019 Page 10/21
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
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
List of nationally authorised medicinal products EMA/280811/2019 Page 11/21
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
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
List of nationally authorised medicinal products EMA/280811/2019 Page 12/21
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
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
List of nationally authorised medicinal products EMA/280811/2019 Page 13/21
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 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
List of nationally authorised medicinal products EMA/280811/2019 Page 14/21
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
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
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
List of nationally authorised medicinal products EMA/280811/2019 Page 16/21
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
(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
List of nationally authorised medicinal products EMA/280811/2019 Page 17/21
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
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
List of nationally authorised medicinal products EMA/280811/2019 Page 18/21
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
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
List of nationally authorised medicinal products EMA/280811/2019 Page 19/21
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
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
List of nationally authorised medicinal products EMA/280811/2019 Page 20/21
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
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
List of nationally authorised medicinal products EMA/280811/2019 Page 21/21
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
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
