Amversio (betaine anhydrous)
Generic
- Region
- 🇪🇺 EU
- Active substance
- betaine anhydrous
- Company
- SERB SA
- Status
- Authorised
- Therapeutic area
- Homocystinuria
- CHMP opinion
- Thu 24 Feb 2022
- EU approval
- Thu 05 May 2022
- Designations
- Generic
- Application
- EMEA/H/C/005637
- ATC
- A16AA06
- Official record
- www.ema.europa.eu
Indication
Amversio is indicated as adjunctive treatment of homocystinuria, involving deficiencies or defects in: cystathionine beta-synthase (CBS), 5,10 methylene tetrahydrofolate reductase (MTHFR), cobalamin cofactor metabolism (cbl).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Cystadane Authorised · Recordati Rare Diseases
Follow Amversio
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.