Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Orphacol   
Auth. number : EU/1/13/870
Active substance : Cholic acid
Orphan market exclusivity for "Treatment of inborn errors in primary bile acid synthesis" (based on designation EU/3/02/127) started on 16/09/2013
   10 years of market exclusivity
   This orphan market exclusivity will expire on 16/09/2023
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: Treatment of inborn errors in primary bile acid synthesis due to 3β-Hydroxy-Δ5-C27-steroid oxidoreductase deficiency or Δ43-Oxosteroid-5β-reductase deficiency in infants, children and adolescents aged 1 month to 18 years and adults
Marketing Authorisation Holder: Laboratoires CTRS
63 rue de l'Est, 92100 Boulogne-Billancourt, France
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
29/05/2012 Centralised - Refusal of marketing authorisation EMEA/H/C/1250 (2012)3306 cor of 25/05/2012
14/06/2012 Corrigendum (2012)4057 of 12/06/2012
16/09/2013 Centralised - Authorisation EMEA/H/C/1250 (2013)5934 of 12/09/2013
16/09/2013 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/1250 (2013)5936 of 12/09/2013
11/11/2013 Centralised - Variation EMEA/H/C/1250/IB/1/G
Updated with Decision(2014)10087 of 16/12/2014
18/12/2014 Centralised - Yearly update (2014)10087 of 16/12/2014
24/03/2015 Centralised - Annual reassessment EMEA/H/C/1250/S/8 (2015)2005 of 19/03/2015
28/01/2016 Centralised - Annual reassessment EMEA/H/C/1250/S/12
26/01/2017 Centralised - Annual reassessment EMEA/H/C/1250/S/16
16/05/2017 Centralised - Variation EMEA/H/C/1250/IB/20/G
Updated with Decision(2018)3061 of 08/05/2018
04/08/2017 Centralised - Variation EMEA/H/C/1250/IA/21
Updated with Decision(2018)3061 of 08/05/2018
22/02/2018 Centralised - Annual reassessment EMEA/H/C/1250/S/22
15/05/2018 Centralised - Yearly update (2018)3061 of 08/05/2018
11/06/2018 Corrigendum (2018)3061 of 08/05/2018