Carbaglu (carglumic acid)
- Region
- 🇪🇺 EU
- Active substance
- carglumic acid
- Company
- Recordati Rare Diseases
- Status
- Authorised
- Therapeutic area
- Amino Acid Metabolism, Inborn Errors; Propionic Acidemia
- EU approval
- Fri 24 Jan 2003
- Application
- EMEA/H/C/000461
- ATC
- A16AA05
- Official record
- www.ema.europa.eu
Indication
Carbaglu is indicated in treatment of: hyperammonaemia due to N-acetylglutamate-synthase primary deficiency; hyperammonaemia due to isovaleric acidaemia; hyperammonaemia due to methymalonic acidaemia; hyperammonaemia due to propionic acidaemia.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Ucedane Authorised · Eurocept International BV
Follow Carbaglu
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.