Opfolda (miglustat)
- Region
- 🇪🇺 EU
- Active substance
- miglustat
- Company
- Amicus Therapeutics Europe Limited
- Status
- Authorised
- Therapeutic area
- Glycogen Storage Disease Type II
- CHMP opinion
- Wed 26 Apr 2023
- EU approval
- Mon 26 Jun 2023
- Application
- EMEA/H/C/005695
- ATC
- A16AX06
- Official record
- www.ema.europa.eu
Indication
Opfolda (miglustat) is an enzyme stabiliser of cipaglucosidase alfa long-term enzyme replacement therapy in adults with late-onset Pompe disease (acid ?- glucosidase [GAA] deficiency).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Veanibek (previously Miglustat Gen.Orph) Authorised · Gen.Orph
- 🇪🇺 Miglustat Dipharma Authorised · Dipharma Arzneimittel GmbH
- 🇪🇺 Zavesca Authorised · Advanz Pharma Limited
- 🇪🇺 Yargesa Authorised · Piramal Critical Care B.V.
- 🇪🇺 Miglustat Gen.Orph Authorised · Gen.Orph
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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.