Ammonaps (sodium phenylbutyrate)
- Region
- 🇪🇺 EU
- Active substance
- sodium phenylbutyrate
- Company
- Immedica Pharma AB
- Status
- Authorised
- Therapeutic area
- Ornithine Carbamoyltransferase Deficiency Disease; Citrullinemia; Carbamoyl-Phosphate Synthase I Deficiency Disease
- EU approval
- Tue 07 Dec 1999
- Application
- EMEA/H/C/000219
- ATC
- A16AX03
- Official record
- www.ema.europa.eu
Indication
Ammonaps is indicated as adjunctive therapy in the chronic management of urea cycle disorders, involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase orargininosuccinate synthetase. It is indicated in all patients with neonatal-onset presentation (complete enzyme deficiencies, presenting within the first 28 days of life). It is also indicated in patients with late-onset disease(partial enzyme deficiencies, presenting after the first month of life) who have a history of hyperammonaemic encephalopathy.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Pheburane Authorised · Eurocept International B. V.
- 🇪🇺 Albrioza Refused · Amylyx Pharmaceuticals EMEA B.V.
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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.