Pharmaceuticals - Union Register


Union Register of medicinal products for human use


Product information

Invented name: OCALIVA   
Auth. number : EU/1/16/1139
Active substance : obeticholic acid
Orphan market exclusivity for "Treatment of primary biliary cirrhosis" (based on designation EU/3/10/753) started on 15/12/2016
   10 years of market exclusivity
   This orphan market exclusivity will expire on 15/12/2026
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: A05AA04 - obeticholic acid
(See WHO ATC Index)
Indication: OCALIVA is indicated for the treatment of primary biliary cholangitis (also known as primary biliary cirrhosis) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.
Marketing Authorisation Holder: Intercept Pharma International Ltd.
10 Earlsfort Terrace, 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 Union Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
15/12/2016 Centralised - Authorisation EMEA/H/C/4093 (2016)8685 of 12/12/2016
21/04/2017 Centralised - Variation EMEA/H/C/4093/IB/1/G
Updated with Decision(2017)8314 of 01/12/2017
5/12/2017 Centralised - Annual renewal EMEA/H/C/4093/R/2 (2017)8314 of 1/12/2017
23/03/2018 PSUSA - Modification EMEA/H/C/4093/PSUSA/10555/201706 (2018)1899 of 21/03/2018
17/10/2018 Centralised - Variation EMEA/H/C/4093/IB/11
Updated with Decision(2018)8909 of 12/12/2018
17/12/2018 Centralised - Annual renewal EMEA/H/C/4093/R/9 (2018)8909 of 12/12/2018
28/01/2019 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/004093/T/0012 (2019)680 of 23/01/2019
8/02/2019 Centralised - Variation EMEA/H/C/4093/IAIN/13/G
22/03/2019 Centralised - Variation EMEA/H/C/4093/IAIN/05