Orphacol (cholic acid)
Exceptional circumstancesAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- cholic acid
- Company
- Theravia
- Status
- Authorised
- Therapeutic area
- Digestive System Diseases; Metabolism, Inborn Errors
- CHMP opinion
- Thu 16 Dec 2010
- EU approval
- Thu 12 Sep 2013
- Designations
- Exceptional circumstances, Additional monitoring
- Application
- EMEA/H/C/001250
- ATC
- A05AA03
- Official record
- www.ema.europa.eu
Indication
Orphacol is indicated for the treatment of inborn errors in primary bile acid synthesis due to3β-Hydroxy-Δ5-C27-steroid oxidoreductase deficiency or Δ4-3-Oxosteroid-5β-reductase deficiency ininfants, children and adolescents aged 1 month to 18 years and adults.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Chenodeoxycholic acid Leadiant (previously Chenodeoxycholic acid sigma-tau) Authorised · Leadiant Biosciences Ireland Limited
- 🇪🇺 Ocaliva Revoked · Advanz Pharma Limited
- 🇪🇺 Zektayos - Hepjuvo Application withdrawn · Advanz Pharma Limited
- 🇪🇺 Kolbam Withdrawn · Retrophin Europe Ltd
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