Replagal
What Replagal is used for
Replagal is indicated for long-term enzyme-replacement therapy in patients with a confirmed diagnosis of Fabry disease (?-galactosidase-A deficiency).
Approved use, as published by the European Medicines Agency.
Key facts
- Brand
- Replagal
- Active substance
- agalsidase alfa
- Disease area
- Fabry Disease
- Medicine group
- Other alimentary tract and metabolism products
- ATC code
- A16AB03
- Marketing authorisation holder
- Takeda Pharmaceuticals International AG Ireland Branch
- Authorised in the EU since
- 2001
Official information
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Replagal used for?
Replagal is indicated for long-term enzyme-replacement therapy in patients with a confirmed diagnosis of Fabry disease (?-galactosidase-A deficiency).
What is the active substance in Replagal?
Replagal contains agalsidase alfa.
Who makes Replagal?
The EU marketing authorisation holder is Takeda Pharmaceuticals International AG Ireland Branch.
Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.
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