Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Kolbam   
Remark: For the calculation of the market exclusivity period associated with the decision C(2015)8362 (final) in application of Article 8(1) of Regulation (EC) No 141/2000, the period of 1 year, 2 months and 3 days during which the Commission Implementing Decision C(2014)2375 (final) of 4 April 2014 was valid should be deducted. The market exclusivity period ends the 21 September 2024.
Auth. number : EU/1/13/895
Active substance : cholic acid
Orphan market exclusivity for "Treatment of inborn errors of primary bile acid synthesis responsive to treatment with cholic acid" (based on designation EU/3/09/683) started on 08/04/2014
   10 years of market exclusivity
   This orphan market exclusivity has ended on 11/06/2015
Orphan market exclusivity for "Treatment of inborn errors of primary bile acid synthesis responsive to treatment with cholic acid" (based on designation EU/3/09/683) started on 24/11/2015
   10 years of market exclusivity
   This orphan market exclusivity will expire on 24/11/2025
ATC: Anatomical main group: A - Alimentary tract and metabolism
Therapeutic subgroup: A05 - Bile and liver therapy
Pharmacological subgroup: A05A - Bile therapy
Chemical subgroup: A05AA - Bile acid preparations
Chemical substance: A05AA03 - Cholic acid
(See WHO ATC Index)
Indication: Kolbam is indicated for the treatment of inborn errors in primary bile acid synthesis due to Sterol 27-hydroxylase (presenting as cerebrotendinous xanthomatosis, CTX) deficiency, 2- (or α-) methylacyl-CoA racemase (AMACR) deficiency or Cholesterol 7α-hydroxylase (CYP7A1) deficiency in infants, children and adolescents aged 1 month to 18 years and adults.
Marketing Authorisation Holder: Retrophin Europe Limited
Palmerstown House, Fenian Street, Dublin 2, Ireland
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
08/04/2014 Centralised - Authorisation EMEA/H/C/2081 (2014)2375 of 04/04/2014
06/08/2014 Centralised - Variation EMEA/H/C/2081/IAin/1
Updated with Decision(2014)6508 of 11/09/2014
15/09/2014 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2081/T/4 (2014)6508 of 11/09/2014
02/12/2014 Centralised - Variation EMEA/H/C/2081/IAin/7/G, EMEA/H/C/2081/IAin/9
Updated with Decision(2015)3935 of 05/06/2015
09/06/2015 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2081/T/11 (2015)3935 of 05/06/2015
24/11/2015 Centralised - Authorisation EMEA/H/C/2081 (2015)8362 of 20/11/2015
11/01/2016 Centralised - Variation EMEA/H/C/2081/IAIN/14
02/06/2016 Centralised - Variation EMEA/H/C/2081/IAIN/15/G