Miglustat Dipharma (miglustat)
- Region
- 🇪🇺 EU
- Active substance
- miglustat
- Company
- Dipharma Arzneimittel GmbH
- Status
- Authorised
- Therapeutic area
- Gaucher Disease
- CHMP opinion
- Thu 13 Dec 2018
- EU approval
- Mon 18 Feb 2019
- Designations
- Generic
- Application
- EMEA/H/C/004904
- ATC
- A16AX06
- Official record
- www.ema.europa.eu
Indication
Miglustat Dipharma is indicated for the oral treatment of adult patients with mild to moderate type 1 Gaucher disease. Miglustat Dipharma may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable. Miglustat Dipharma 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
- 🇪🇺 Zavesca Authorised · Advanz Pharma Limited
- 🇪🇺 Yargesa Authorised · Piramal Critical Care B.V.
- 🇪🇺 Miglustat Gen.Orph Authorised · Gen.Orph
- 🇪🇺 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.