Myozyme (alglucosidase alfa)
- Region
- 🇪🇺 EU
- Active substance
- alglucosidase alfa
- Company
- Sanofi B.V.
- Status
- Authorised
- Therapeutic area
- Glycogen Storage Disease Type II
- EU approval
- Tue 28 Mar 2006
- Application
- EMEA/H/C/000636
- ATC
- A16AB07
- Official record
- www.ema.europa.eu
Indication
Myozyme is indicated for long-term enzyme-replacement therapy (ERT) in patients with a confirmed diagnosis of Pompe disease (acid-?-glucosidase deficiency). In patients with late-onset Pompe disease the evidence of efficacy is limited.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Nexviadyme Authorised · Sanofi B.V.
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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.