Kolbam (cholic acid)
- Region
- 🇪🇺 EU
- Active substance
- cholic acid
- Company
- Retrophin Europe Ltd
- Status
- Withdrawn
- Therapeutic area
- Metabolism, Inborn Errors
- CHMP opinion
- Thu 21 Nov 2013
- EU approval
- Fri 20 Nov 2015
- Designations
- Exceptional circumstances
- Application
- EMEA/H/C/002081
- ATC
- A05AA03
- Official record
- www.ema.europa.eu
Indication
Cholic Acid FGK is indicated for the treatment of inborn errors of primary bile acid synthesis, in infants from one month of age for continuous lifelong treatment through adulthood, encompassing the following single enzyme defects: sterol 27-hydroxylase (presenting as cerebrotendinous xanthomatosis, CTX) deficiency; 2- (or alpha-) methylacyl-CoA racemase (AMACR) deficiency; cholesterol 7 alpha-hydroxylase (CYP7A1) deficiency.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Orphacol Authorised · Theravia
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- 🇪🇺 Ocaliva Revoked · Advanz Pharma Limited
- 🇪🇺 Zektayos - Hepjuvo Application withdrawn · Advanz Pharma Limited
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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.