Kolbam

cholic acid

Overview
Authorisation details
Product information
Assessment history

Withdrawn

This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Kolbam has been withdrawn at the request of the marketing-authorisation holder.

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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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Kolbam : EPAR - Risk-management-plan summary (PDF/661.04 KB)

First published: 09/12/2015
Last updated: 15/07/2020

This EPAR was last updated on 15/07/2020

Authorisation details

Product details
Name	Kolbam
Agency product number	EMEA/H/C/002081
Active substance	cholic acid
International non-proprietary name (INN) or common name	cholic acid
Therapeutic area (MeSH)	Metabolism, Inborn Errors
Anatomical therapeutic chemical (ATC) code	A05AA03
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
Marketing-authorisation holder	Retrophin Europe Ltd
Revision	14
Date of issue of marketing authorisation valid throughout the European Union	20/11/2015
Contact address	Palmerston House Fenian Street Dublin 2 Ireland

Product information

27/03/2020 Kolbam - EMEA/H/C/002081 - N/0033

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Kolbam : EPAR - Product Information (PDF/1.31 MB)

First published: 03/12/2015
Last updated: 15/07/2020
- Bulgarian
  (PDF/2.23 MB)
- Croatian
  (PDF/1.29 MB)
- Czech
  (PDF/1.87 MB)
- Danish
  (PDF/1.24 MB)
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  (PDF/1.27 MB)
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  (PDF/1.26 MB)
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  (PDF/1.24 MB)
- French
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- German
  (PDF/1.33 MB)
- Greek
  (PDF/2.34 MB)
- Hungarian
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- Icelandic
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- Italian
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- Latvian
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- Lithuanian
  (PDF/1.27 MB)
- Maltese
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- Norwegian
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- Portuguese
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- Romanian
  (PDF/1.33 MB)
- Slovak
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- Slovenian
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- Spanish
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Other EU languages available icon 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.

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Kolbam : EPAR - All Authorised presentations (PDF/598.76 KB)

First published: 09/12/2015
Last updated: 15/07/2020
- Bulgarian
  (PDF/642.4 KB)
- Croatian
  (PDF/605.75 KB)
- Czech
  (PDF/629.39 KB)
- Danish
  (PDF/598.68 KB)
- Dutch
  (PDF/600.66 KB)
- Estonian
  (PDF/598.65 KB)
- Finnish
  (PDF/598.38 KB)
- French
  (PDF/598.78 KB)
- German
  (PDF/598.85 KB)
- Greek
  (PDF/80.44 KB)
- Hungarian
  (PDF/628.35 KB)
- Icelandic
  (PDF/598.46 KB)
- Italian
  (PDF/598.86 KB)
- Latvian
  (PDF/633.12 KB)
- Lithuanian
  (PDF/614.12 KB)
- Maltese
  (PDF/628.86 KB)
- Norwegian
  (PDF/598.85 KB)
- Polish
  (PDF/629.02 KB)
- Portuguese
  (PDF/598.8 KB)
- Romanian
  (PDF/614.44 KB)
- Slovak
  (PDF/630.25 KB)
- Slovenian
  (PDF/619.93 KB)
- Spanish
  (PDF/601.46 KB)
- Swedish
  (PDF/598.74 KB)

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.

Kolbam

Table of contents

Overview

Kolbam : EPAR - Summary for the public (PDF/702.36 KB)

Kolbam : EPAR - Risk-management-plan summary (PDF/661.04 KB)

Authorisation details

Product information

Kolbam : EPAR - Product Information (PDF/1.31 MB)

Kolbam : EPAR - All Authorised presentations (PDF/598.76 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Kolbam : EPAR - Procedural steps taken and scientific information after authorisation (PDF/830.36 KB)

Kolbam-H-C-PSUSA-00010182-201903 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/1.26 MB)

Initial marketing-authorisation documents

Kolbam : EPAR - Public assessment report (PDF/2.52 MB)

CHMP summary of opinion for Kolbam (PDF/666.12 KB)

CHMP summary of positive opinion Kolbam (PDF/666.12 KB)

News

More information on Kolbam

Public statement on Kolbam: Withdrawal of the marketing authorisation in the European Union (PDF/668.75 KB)

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