Ocaliva
Revoked
This medicine's authorisation has been revoked
obeticholic acid
MedicineHumanRevoked
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
The marketing authorization of Ocaliva was revoked by the Commission Implementing Decision of 30 August 2024.
Ocaliva : EPAR - Summary for the public
English (EN) (175.36 KB - PDF)
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български (BG) (244.89 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
español (ES) (174.65 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
čeština (CS) (214.92 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
dansk (DA) (167.05 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
Deutsch (DE) (178.84 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
eesti keel (ET) (161.72 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
ελληνικά (EL) (256.42 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
français (FR) (175.94 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
hrvatski (HR) (203 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
italiano (IT) (170.01 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
latviešu valoda (LV) (214.94 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
lietuvių kalba (LT) (218.27 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
magyar (HU) (200.8 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
Malti (MT) (225.27 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
Nederlands (NL) (174.96 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
polski (PL) (217.59 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
português (PT) (173.38 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
română (RO) (221.53 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
slovenčina (SK) (212.57 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
slovenščina (SL) (206.33 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
Suomi (FI) (164.65 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
svenska (SV) (169.61 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
Ocaliva : EPAR - Risk management plan summary
English (EN) (453.6 KB - PDF)
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Product information
Ocaliva : EPAR - Product Information
English (EN) (1.19 MB - PDF)
First published: Last updated:
български (BG) (1.56 MB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
español (ES) (1.49 MB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
čeština (CS) (1.56 MB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
dansk (DA) (1.37 MB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
Deutsch (DE) (1.43 MB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
eesti keel (ET) (1.3 MB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
ελληνικά (EL) (1.89 MB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
français (FR) (1.56 MB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
hrvatski (HR) (1.59 MB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
íslenska (IS) (1.34 MB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
italiano (IT) (1.49 MB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
latviešu valoda (LV) (1.61 MB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
lietuvių kalba (LT) (1.58 MB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
magyar (HU) (1.61 MB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
Malti (MT) (1.77 MB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
Nederlands (NL) (1.47 MB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
norsk (NO) (1.36 MB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
polski (PL) (1.66 MB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
português (PT) (1.44 MB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
română (RO) (1.65 MB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
slovenčina (SK) (1.57 MB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
slovenščina (SL) (1.52 MB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
Suomi (FI) (1.35 MB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
svenska (SV) (1.39 MB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
Latest procedure affecting product information:
N/0048
16/04/2024
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).
Ocaliva : EPAR - All Authorised presentations
English (EN) (56.54 KB - PDF)
First published: Last updated:
български (BG) (91.25 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
español (ES) (77.7 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
čeština (CS) (60.89 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
dansk (DA) (52.88 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
Deutsch (DE) (53.8 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
eesti keel (ET) (55.05 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
ελληνικά (EL) (89.95 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
français (FR) (54.01 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
hrvatski (HR) (76.51 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
íslenska (IS) (52.19 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
italiano (IT) (54.1 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
latviešu valoda (LV) (76.52 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
lietuvių kalba (LT) (73.41 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
magyar (HU) (62.12 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
Malti (MT) (73.07 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
Nederlands (NL) (52.24 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
norsk (NO) (52.61 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
polski (PL) (61.61 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
português (PT) (54.97 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
română (RO) (71.14 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
slovenčina (SK) (72.18 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
slovenščina (SL) (61.78 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
Suomi (FI) (52.16 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
svenska (SV) (52.92 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
Product details
- Name of medicine
- Ocaliva
- Active substance
- Obeticholic acid
- International non-proprietary name (INN) or common name
- obeticholic acid
- Therapeutic area (MeSH)
- Liver Cirrhosis, Biliary
- Anatomical therapeutic chemical (ATC) code
- A05AA04
Pharmacotherapeutic group
Bile and liver therapyTherapeutic 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.
Authorisation details
- EMA product number
- EMEA/H/C/004093
Conditional approval
This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.
- Marketing authorisation holder
- Advanz Pharma Limited
Unit 17
Northwood House
Northwood Crescent
Dublin 9
D09 V504
Ireland - Opinion adopted
- 13/10/2016
- Marketing authorisation issued
- 12/12/2016
- Revocation of marketing authorisation
- 30/08/2024
- Revision
- 21
Assessment history
Ocaliva : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (1.57 MB - PDF)
First published: Last updated:
Ocaliva-H-C-004093-II-0038 : EPAR - Refusal assessment report - variation
AdoptedReference Number: EMA/528620/2023
English (EN) (22.98 MB - PDF)
First published: Last updated:
Ocaliva-H-C-PSUSA-00010555-201706 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
Reference Number: EMA/289133/2018
English (EN) (116.47 KB - PDF)
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Ocaliva : EPAR - Conclusions on the granting of the conditional marketing authorisation
English (EN) (158.23 KB - PDF)
First published: Last updated:
български (BG) (255.86 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
español (ES) (159.07 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
čeština (CS) (217.91 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
dansk (DA) (159.4 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
Deutsch (DE) (161.9 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
eesti keel (ET) (155.06 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
ελληνικά (EL) (234.28 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
français (FR) (161.27 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
hrvatski (HR) (224 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
íslenska (IS) (153.44 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
italiano (IT) (189.58 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
latviešu valoda (LV) (211.99 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
lietuvių kalba (LT) (227.17 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
magyar (HU) (235.22 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
Malti (MT) (246.14 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
Nederlands (NL) (160.44 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
norsk (NO) (160.62 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
polski (PL) (218.47 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
português (PT) (160.43 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
română (RO) (229.26 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
slovenčina (SK) (237.4 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
slovenščina (SL) (239.76 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
Suomi (FI) (155.12 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
svenska (SV) (156.85 KB - PDF)
First published: 19/12/2016Last updated: 20/01/2025
Ocaliva : EPAR - Public assessment report
AdoptedReference Number: EMA/725757/2016
English (EN) (9.37 MB - PDF)
First published: Last updated:
CHMP summary of positive opinion for Ocaliva
AdoptedReference Number: EMA/CHMP/651446/2016
English (EN) (160.81 KB - PDF)
First published: Last updated:
News on Ocaliva
- Clinical data (initial marketing authorisation)
More information on Ocaliva
This product was originally designated an orphan medicine on 27 July 2010. Ocaliva was withdrawn from the Community register of orphan medicinal products by the European Commission in September 2024 at the time of the revoking of the marketing authorisation.
More information on Ocaliva
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