Miglustat Gen.Orph (miglustat)
- Region
- 🇪🇺 EU
- Active substance
- miglustat
- Company
- Gen.Orph
- Status
- Authorised
- Therapeutic area
- Gaucher Disease
- EU approval
- Thu 09 Nov 2017
- Designations
- Generic
- Application
- EMEA/H/C/004366
- ATC
- A16AX06
- Official record
- www.ema.europa.eu
Indication
Miglustat Gen.Orph is indicated for the oral treatment of adult patients with mild to moderate type 1 Gaucher disease. Miglustat Gen.Orph may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable. Miglustat Gen.Orph is indicated for the treatment of progressive neurological manifestations in adult patients and paediatric patients with Niemann-Pick type C disease.
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.
- 🇪🇺 Opfolda Authorised · Amicus Therapeutics Europe Limited
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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.