Agalsidase alfa

Replagal®

1mg/mL koncentrat za rastvor za infuzijuSerbiaAuthorisedAuthorised 17 Aug 2023

In other countries

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

ReplagalCanada · 1 MG / ML · Solution · Takeda Canada INCSame brand
REPLAGAL 1 mg/ml CONCENTRADO PARA SOLUCION PARA PERFUSIONSpain · 1 mg · concentrado para solución para perfusión · Takeda Pharmaceuticals International Ag Ireland BranchSame brand
REPLAGAL 1 mg/ml CONCENTRADO PARA SOLUCION PARA PERFUSIONSpain · 1 mg · concentrado para solución para perfusión · Shire Human Genetic Therapies AbSame 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

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

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Agalsidase alfa

Replagal®

1mg/mL koncentrat za rastvor za infuzijuSerbiaAuthorisedAuthorised 17 Aug 2023

Ask 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 1 mg/ml, concentraat voor oplossing voor intraveneuze infusieNetherlands · Concentraat voor oplossing voor infusie · Takeda Pharmaceuticals International AG Ireland Branch

REPLAGAL 1mg/mlRomania · 1mg/ml · conc. pt. sol. perf. · Shire Human Genetic Therapies AB

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.

Sources and licences

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

ALIMS

ALIMS, Registar humanih lekova, source 08.10.2026 02:00, downloaded 2026-10-08, https://data.gov.rs/sr/datasets/lekovi-za-upotrebu-u-khumanoj-meditsini/; structured factual adaptation; Serbian Open Data Licence.

Licence: Serbian Open Data Licence (sodl) sodl · Added 9 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: 1mg/mL
Dosage form: koncentrat za rastvor za infuziju
Route: parenteralno
Register: Serbia (ALIMS)
Status: Authorised
Status in the register: OBNOVA
Authorised: 17 Aug 2023
Registration: 471237
Marketing authorisation holder: Takeda DOO
Manufacturer: SHIRE PHARMACEUTICALS IRELAND LIMITED - Irska
ATC code: A16AB03
Group: Alimentary tract and metabolism
Procedure: Biološki lekovi
Supply: SZR