Kolbam
cholic acid
Table of contents
Overview
The marketing authorisation for Kolbam has been withdrawn at the request of the marketing-authorisation holder.
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List item
Kolbam : EPAR - Summary for the public (PDF/702.36 KB)
First published: 09/12/2015
Last updated: 15/07/2020
EMA/640371/2015 -
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List item
Kolbam : EPAR - Risk-management-plan summary (PDF/661.04 KB)
First published: 09/12/2015
Last updated: 15/07/2020
Authorisation details
Product details | |
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Name |
Kolbam
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Agency product number |
EMEA/H/C/002081
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Active substance |
cholic acid
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International non-proprietary name (INN) or common name |
cholic acid
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Therapeutic area (MeSH) |
Metabolism, Inborn Errors
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Anatomical therapeutic chemical (ATC) code |
A05AA03
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Exceptional circumstances |
This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance. |
Publication details | |
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Marketing-authorisation holder |
Retrophin Europe Ltd
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Revision |
14
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Date of issue of marketing authorisation valid throughout the European Union |
20/11/2015
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Contact address |
Palmerston House
Fenian Street Dublin 2 Ireland |
Product information
27/03/2020 Kolbam - EMEA/H/C/002081 - N/0033
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Bile and liver therapy
Therapeutic 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.
Assessment history
News
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25/09/2015
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 January 201424/01/2014
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22/11/2013