Ravicti (glycerol phenylbutyrate)
- Region
- 🇪🇺 EU
- Active substance
- glycerol phenylbutyrate
- Company
- Immedica Pharma AB
- Status
- Authorised
- Therapeutic area
- Urea Cycle Disorders, Inborn
- CHMP opinion
- Wed 23 Sep 2015
- EU approval
- Thu 26 Nov 2015
- Designations
- Orphan
- Application
- EMEA/H/C/003822
- ATC
- A16AX09
- Official record
- www.ema.europa.eu
Indication
Ravicti is indicated for use as adjunctive therapy for chronic management of patients with urea cycle disorders (UCDs) including deficiencies of carbamoyl phosphate-synthase-I (CPS), ornithine carbamoyltransferase (OTC), argininosuccinate synthetase (ASS), argininosuccinate lyase (ASL), arginase I (ARG) and ornithine translocase deficiency hyperornithinaemia-hyperammonaemia homocitrullinuria syndrome (HHH) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. Ravicti must be used with dietary protein restriction and, in some cases, dietary supplements (e.g., essential amino acids, arginine, citrulline, protein-free calorie supplements).
Regulatory milestones
No milestones recorded in the last year.
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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.