Vpriv (velaglucerase alfa)
Accelerated assessment
- Region
- 🇪🇺 EU
- Active substance
- velaglucerase alfa
- Company
- Takeda Pharmaceuticals International AG Ireland Branch
- Status
- Authorised
- Therapeutic area
- Gaucher Disease
- CHMP opinion
- Fri 04 Jun 2010
- EU approval
- Thu 26 Aug 2010
- Designations
- Accelerated assessment
- Application
- EMEA/H/C/001249
- ATC
- A16AB10
- Official record
- www.ema.europa.eu
Indication
Vpriv is indicated for long-term enzyme-replacement therapy (ERT) in patients with type-1 Gaucher disease.
Regulatory milestones
No milestones recorded in the last year.
Follow Vpriv
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
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.