Pheburane (sodium phenylbutyrate)
- Region
- 🇪🇺 EU
- Active substance
- sodium phenylbutyrate
- Company
- Eurocept International B. V.
- Status
- Authorised
- Therapeutic area
- Carbamoyl-Phosphate Synthase I Deficiency Disease
- CHMP opinion
- Thu 21 Feb 2013
- EU approval
- Tue 30 Jul 2013
- Application
- EMEA/H/C/002500
- ATC
- A16AX03
- Official record
- www.ema.europa.eu
Indication
Treatment of chronic management of urea-cycle disorders.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Albrioza Refused · Amylyx Pharmaceuticals EMEA B.V.
- 🇪🇺 Ammonaps Authorised · Immedica Pharma AB
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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.