Ucedane (carglumic acid)
Generic
- Region
- 🇪🇺 EU
- Active substance
- carglumic acid
- Company
- Eurocept International BV
- Status
- Authorised
- Therapeutic area
- Hyperammonemia; Amino Acid Metabolism, Inborn Errors
- CHMP opinion
- Fri 21 Apr 2017
- EU approval
- Fri 23 Jun 2017
- Designations
- Generic
- Application
- EMEA/H/C/004019
- ATC
- A16AA05
- Official record
- www.ema.europa.eu
Indication
Ucedane 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
- 🇪🇺 Carbaglu Authorised · Recordati Rare Diseases
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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.