Agalsidase alfa

REPLAGAL 1 mg/ml CONCENTRADO PARA SOLUCION PARA PERFUSION

1 mg concentrado para solución para perfusiónSpainMarketedAuthorised 10 Feb 2002

In other countries

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

ReplagalCanada · 1 MG / ML · Solution · Takeda Canada INCSame brand
ReplagalEuropean Union · Takeda Pharmaceuticals International AG Ireland BranchSame brand
ReplagalCroatiaSame brand
ReplagalItaly · Concentrato per soluzione per infusione · Takeda Pharmaceuticals International AG Ireland BranchSame brand
Replagal 1 mg/ml, concentraat voor oplossing voor intraveneuze infusieNetherlands · Concentraat voor oplossing voor infusie · Takeda Pharmaceuticals International AG Ireland BranchSame brand
REPLAGAL 1mg/mlRomania · 1mg/ml · conc. pt. sol. perf. · Shire Human Genetic Therapies ABSame brand
Replagal®Serbia · 1mg/mL · koncentrat za rastvor za infuziju · Takeda DOO

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Agalsidase alfa

REPLAGAL 1 mg/ml CONCENTRADO PARA SOLUCION PARA PERFUSION

1 mg concentrado para solución para perfusiónSpainMarketedAuthorised 10 Feb 2002

Product informationAsk Osler about it

In other countries

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

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.

Discover Osler

Replagal®Serbia · 1mg/mL · koncentrat za rastvor za infuziju · Takeda DOO

REPLAGAL 1mg/ml concetrate for solution for infusionSaudi Arabia · Cangene BioPharma Inc. (CBI)

Replagal Concentrate for Solution for Infusion 1 MG/MLSingapore · 1.0 mg/mL · infusion, solution concentrate · Takeda Pharmaceuticals (Asia Pacific) Pte. LTD.

Packs

Pack	Code	Status
REPLAGAL 1 mg/ml CONCENTRADO PARA SOLUCION PARA PERFUSION, 1 vial de 3,5 ml	880740

Documents

The official texts, at the regulator.

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: Agalsidase alfa
Strength: 1 mg
Dosage form: concentrado para solución para perfusión
Route: vía intravenosa
Register: Spain (AEMPS)
Status: Marketed
Status in the register: Autorizado, comercializado
Authorised: 10 Feb 2002
Registration: 01189001
Marketing authorisation holder: Takeda Pharmaceuticals International Ag Ireland Branch
Procedure: EU centralised
Supply: Uso Hospitalario