Replagal (agalsidase alfa)
- Region
- 🇪🇺 EU
- Active substance
- agalsidase alfa
- Company
- Takeda Pharmaceuticals International AG Ireland Branch
- Status
- Authorised
- Therapeutic area
- Fabry Disease
- CHMP opinion
- Thu 29 Mar 2001
- EU approval
- Fri 03 Aug 2001
- Application
- EMEA/H/C/000369
- ATC
- A16AB03
- Official record
- www.ema.europa.eu
Indication
Replagal is indicated for long-term enzyme-replacement therapy in patients with a confirmed diagnosis of Fabry disease (?-galactosidase-A deficiency).
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.