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Medicines
Spain
Acetylcysteine

AEMPS 2003

Acetylcysteine

FLUIMUCIL 40mg/ml SOLUCION ORAL

4,000 g solución oralSpainMarketedAuthorised 22 Jul 2003

Product informationAsk Osler about it

On this page

In other countries
Packs
Documents
Sources and licences

In other countries

The same active substances on other registers, the same brand first.

FluimucilBrazil · Zambon Laboratórios Farmacêuticos Ltda.Same brand
FluimucilItaly · Compressa effervescente · Medifarm S.R.L.Same brand
FluimucilItaly · Soluzione iniettabile · Difarmed Sociedad Limitada UnipersonalSame brand
FluimucilItaly · Compressa effervescente · BB Farma S.R.L.Same brand
Fluimucil 100 mg/ml, oplossing voor inhalatiedampNetherlands · Oplossing voor inhalatiedamp · Zambon Nederland B.V.Same brand
Fluimucil 20 mg/ml DrankNetherlands · Drank · Zambon Nederland B.V.Same brand
Fluimucil 200 mg Bruis, bruistablettenNetherlands · Bruistablet · Zambon Nederland B.V.

More with the same substance on this register

Acetilcisteina Alter 600 MG Comprimidos Efervescentes EfgAcetylcysteine · 600 mg · comprimido efervescenteSpain
ACETILCISTEÍNA BEXAL 200 mg POLVO PARA SOLUCIÓN ORAL EFGAcetylcysteine · 200 mg · polvo para solución oral

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

Same brand

🇷🇴FLUIMUCIL 20 mg/ml PEDIATRICRomania · 20mg/ml · sol. orala · Zambon S.P.A.Same brand

🇷🇴FLUIMUCIL 300 mg/3 mlRomania · 300mg/3ml · sol.inj./inhal.nebuliz./instilatie endotraheobron. · Zambon S.P.A.Same brand

🇷🇸Fluimucil® za decuSerbia · 100mg/5mL · oralni rastvor · Bonifar DOO Novi BeogradSame brand

🇷🇸Fluimucil®Serbia · 300mg/3mL · rastvor za injekciju · Bonifar DOO Novi BeogradSame brand

🇷🇸Fluimucil® 100Serbia · 100mg · granule za oralni rastvor · Bonifar DOO Novi BeogradSame brand

🇸🇦Fluimucil 100MG/1GM Granules for Oral SolutionSaudi Arabia · Zambon Switzerland LTDSame brand

🇸🇦Fluimucil 200MG/1GM Granules for Oral SolutionSaudi Arabia · Zambon Switzerland LTDSame brand

🇸🇬Fluimucil A 600 Effervescent Tablet 600MG (OTC Pack)Singapore · 600mg · tablet · United Italian Trading Corporation (Private) LimitedSame brand

🇸🇬FLUIMUCIL A 600 EFFERVESCENT TABLET 600MG (Revised Formula)Singapore · 600 mg · tablet · United Italian Trading Corporation (Private) LimitedSame brand

🇸🇬FLUIMUCIL GRANULES 100 mg/sachetSingapore · 100 mg/sachet · granule · United Italian Trading Corporation (Private) LimitedSame brand

🇨🇦Acetylcysteine SolutionCanada · 200 MG / ML · Solution · Sandoz Canada IncorporatedSame form

🇨🇦Acetylcysteine Solution USPCanada · 200 MG / ML · Solution · Sterimax INCSame form

🇨🇦Acetylcysteine Solution USPCanada · 200 MG / ML · Solution · Hikma Canada LimitedSame form

🇭🇷Fluimukan 20 mg/ml oralna otopinaCroatia · oralna otopina · Sandoz d.o.o., Maksimirska 120, Zagreb, HrvatskaSame form

🇺🇸AcetylcysteineUnited States · 10%, 20% · solution · Somerset Theraps LLCSame form

🇺🇸MucomystUnited States · 10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, 20% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution · ApotheconSame form

🇺🇸Mucosil-10United States · 10% · solution · DeySame form

🇧🇷AcetilcisteinaBrazil · Aché Laboratórios Farmacêuticos S.ASame substance

🇧🇷AcetilcisteinaBrazil · União Química Farmacêutica Nacional S/ASame substance

🇭🇷Fluimukan 200 mg šumeće tableteCroatia · Šumeća tableta · Sandoz d.o.o., Maksimirska 120, Zagreb, HrvatskaSame substance

🇭🇷Fluimukan 600 mg prašak za oralnu otopinuCroatia · Prašak za oralnu otopinu · Sandoz d.o.o., Maksimirska 120, Zagreb, HrvatskaSame substance

🇳🇿AnyNew Zealand · Tab eff 200 mgSame substance

🇳🇿DBL AcetylcysteineNew Zealand · Inj 200 mg per ml, 10 ml ampouleSame substance

🇳🇿Hikma AcetylcysteineNew Zealand · Inj 200 mg per ml, 10 ml vialSame substance

🇷🇴ACC INJECT 300 mg/3 mlRomania · 300mg/3ml · sol inj./sol. pt. inhalat prin nebulizator · Hexal AGSame substance

🇸🇦Acc 200MG Powder for Oral SolutionSaudi Arabia · HexalSame substance

🇹🇼Taneasy 600mg granules for oral solutionTaiwan · 內服顆粒劑 · 邦躍生物科技有限公司Same substance

🇹🇼A.R.B. SolutionTaiwan · 口腔吸入劑 · 一成藥品股份有限公司Same substance

🇹🇼Siran 200Taiwan · 散劑 · 環聯貿易有限公司Same substance

Packs

Pack	Code	Status
FLUIMUCIL 40mg/ml SOLUCION ORAL , 100 ml	699010
FLUIMUCIL 40mg/ml SOLUCION ORAL , 1 frasco de 200 ml	939942

Documents

The official texts, at the regulator.

Summary of product characteristicsAEMPS
Package leafletAEMPS
Register entryAEMPS

Sources and licences

Compiled by Prognia from the public register below; the register’s text is the official one.

Agencia Española de Medicamentos y Productos Sanitarios

Fuente de la información: Agencia Española de Medicamentos y Productos Sanitarios www.aemps.gob.es; CIMA medicamentos, acquired 11 October 2026 UTC; each source response/update date retained.

Licence: AEMPS explicit public open-data reuse for citizens and companies; source attribution and update date required · Added 12 Oct 2026

Report an error or request removalCorrections from the holder or the register are welcome.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Active substance: Acetylcysteine
Strength: 4,000 g
Dosage form: solución oral
Route: vía oral
Register: Spain (AEMPS)
Status: Marketed
Status in the register: Autorizado, comercializado
Authorised: 22 Jul 2003
Registration: 65532
Marketing authorisation holder: Zambon S.A.U.
Procedure: National, MRP or DCP
Supply: Sin Receta

🇪🇸Spain

AEMPSACETILCISTEÍNA BEXAL 600 mg COMPRIMIDOS EFERVESCENTES EFGAcetylcysteine · 600 mg · comprimido efervescente🇪🇸Spain

AEMPSACETILCISTEINA CINFA 100 mg POLVO PARA SOLUCION ORAL EFGAcetylcysteine · 100 mg · polvo para solución oral🇪🇸Spain

AEMPSACETILCISTEINA CINFA 200 mg POLVO PARA SOLUCION ORAL EFGAcetylcysteine · 200 mg · polvo para solución oral🇪🇸Spain

AEMPSACETILCISTEINA CINFA 600 mg COMPRIMIDOS EFERVESCENTES EFGAcetylcysteine · 600,0 mg · comprimido efervescente🇪🇸Spain

AEMPSACETILCISTEINA CINFA 600 mg POLVO PARA SOLUCION ORAL EFGAcetylcysteine · 600 mg · polvo para solución oral🇪🇸Spain

AEMPSAcetilcisteina Farmasierra 200 MG Granulado Para Solucion Oral EfgAcetylcysteine · 200 mg · granulado para solución oral🇪🇸Spain

AEMPSAcetilcisteina Farmasierra 600 MG Polvo Efervescente EfgAcetylcysteine · 600 mg · polvo efervescente🇪🇸Spain

AEMPSAcetilcisteina Kern Pharma 100 MG/ML Solucion Inyectable EfgAcetylcysteine · 100 mg/ml · solución inyectable🇪🇸Spain

AEMPSACETILCISTEINA KERN PHARMA 600 mg COMPRIMIDOS EFERVESCENTESAcetylcysteine · 600 mg · comprimido efervescente🇪🇸Spain

AEMPSAcetilcisteina Mabo 600 MG Comprimidos Efervescentes Sabor NaranjaAcetylcysteine · 600,0 mg · comprimido efervescente🇪🇸Spain