Yargesa (miglustat)
- Region
- 🇪🇺 EU
- Active substance
- miglustat
- Company
- Piramal Critical Care B.V.
- Status
- Authorised
- Therapeutic area
- Gaucher Disease
- CHMP opinion
- Thu 26 Jan 2017
- EU approval
- Wed 22 Mar 2017
- Designations
- Generic
- Application
- EMEA/H/C/004016
- ATC
- A16AX06
- Official record
- www.ema.europa.eu
Indication
Yargesa is indicated for the oral treatment of adult patients with mild to moderate type 1 Gaucher disease. Yargesa may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable. Yargesa 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
- 🇪🇺 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.