Overview
The marketing authorisation for Kolbam has been withdrawn at the request of the marketing-authorisation holder.
Kolbam : EPAR - Summary for the public
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slovenščina (SL) (697.14 KB - PDF)
Suomi (FI) (650.22 KB - PDF)
svenska (SV) (651.12 KB - PDF)
Kolbam : EPAR - Risk-management-plan summary
English (EN) (661.04 KB - PDF)
Product information
Kolbam : EPAR - Product Information
English (EN) (1.31 MB - PDF)
български (BG) (2.23 MB - PDF)
español (ES) (1.27 MB - PDF)
čeština (CS) (1.87 MB - PDF)
dansk (DA) (1.24 MB - PDF)
Deutsch (DE) (1.33 MB - PDF)
eesti keel (ET) (1.26 MB - PDF)
ελληνικά (EL) (2.34 MB - PDF)
français (FR) (1.29 MB - PDF)
hrvatski (HR) (1.29 MB - PDF)
íslenska (IS) (1.23 MB - PDF)
italiano (IT) (1.3 MB - PDF)
latviešu valoda (LV) (1.9 MB - PDF)
lietuvių kalba (LT) (1.27 MB - PDF)
magyar (HU) (1.94 MB - PDF)
Malti (MT) (1.95 MB - PDF)
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norsk (NO) (1.21 MB - PDF)
polski (PL) (1.92 MB - PDF)
português (PT) (1.28 MB - PDF)
română (RO) (1.33 MB - PDF)
slovenčina (SK) (1.92 MB - PDF)
slovenščina (SL) (1.83 MB - PDF)
Suomi (FI) (1.24 MB - PDF)
svenska (SV) (1.27 MB - PDF)
Latest procedure affecting product information: N/0033
27/03/2020
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).
Kolbam : EPAR - All Authorised presentations
English (EN) (598.76 KB - PDF)
български (BG) (642.4 KB - PDF)
español (ES) (601.46 KB - PDF)
čeština (CS) (629.39 KB - PDF)
dansk (DA) (598.68 KB - PDF)
Deutsch (DE) (598.85 KB - PDF)
eesti keel (ET) (598.65 KB - PDF)
ελληνικά (EL) (80.44 KB - PDF)
français (FR) (598.78 KB - PDF)
hrvatski (HR) (605.75 KB - PDF)
íslenska (IS) (598.46 KB - PDF)
italiano (IT) (598.86 KB - PDF)
latviešu valoda (LV) (633.12 KB - PDF)
lietuvių kalba (LT) (614.12 KB - PDF)
magyar (HU) (628.35 KB - PDF)
Malti (MT) (628.86 KB - PDF)
Nederlands (NL) (600.66 KB - PDF)
norsk (NO) (598.85 KB - PDF)
polski (PL) (629.02 KB - PDF)
português (PT) (598.8 KB - PDF)
română (RO) (614.44 KB - PDF)
slovenčina (SK) (630.25 KB - PDF)
slovenščina (SL) (619.93 KB - PDF)
Suomi (FI) (598.38 KB - PDF)
svenska (SV) (598.74 KB - PDF)
Product details
- Name of medicine
- Kolbam
- 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
Pharmacotherapeutic group
Bile and liver therapyTherapeutic 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.
Authorisation details
- EMA product number
- EMEA/H/C/002081
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.
- Marketing authorisation holder
- Retrophin Europe Ltd
Palmerston House
Fenian Street
Dublin 2
Ireland - Opinion adopted
- 21/11/2013
- Marketing authorisation issued
- 20/11/2015
- Revision
- 14
Assessment history
Kolbam : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (830.36 KB - PDF)
Kolbam-H-C-PSUSA-00010182-201903 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
English (EN) (1.26 MB - PDF)
Kolbam : EPAR - Public assessment report
English (EN) (2.52 MB - PDF)
CHMP summary of opinion for Kolbam
English (EN) (666.12 KB - PDF)
CHMP summary of positive opinion Kolbam
English (EN) (666.12 KB - PDF)
News on Kolbam
More information on Kolbam
Public statement on Kolbam: Withdrawal of the marketing authorisation in the European Union
English (EN) (668.75 KB - PDF)
This product was originally designated an orphan medicine on 28 October 2009. Kolbam was withdrawn from the Community register of orphan medicinal products by the European Commission in July 2020 at the time of the withdrawal of the marketing authorisation.