Obeticholic acid

Ocaliva 5 MG Comprimidos Recubiertos con Pelicula

5 mg comprimido recubierto con películaSpainWithdrawnAuthorised 31 Jan 2017

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Obeticholic acid

Ocaliva 5 MG Comprimidos Recubiertos con Pelicula

5 mg comprimido recubierto con películaSpainWithdrawnAuthorised 31 Jan 2017

Product informationAsk Osler about it

This page is kept for reference and is not offered to search engines.

In other countries

The same active substances on other registers, the same brand first.

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

Discover Osler

Ocaliva

Saudi Arabia · Piramal Healthcare UK Limited

OcalivaUnited States · 10MG, 5MG · tablet · Intercept

Obeticholic AcidUnited States · 10mg, 10MG, 5MG · tablet · Optimus Pharma Private LTD

Zektayos - HepjuvoEuropean Union · Advanz Pharma Limited

Packs

Pack	Code	Status
OCALIVA 5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA, 30 comprimidos	714584

Documents

The official texts, at the regulator.

Sources and licences

Compiled by Prognia from the public register below; the register’s text is the official one.

Agencia Española de Medicamentos y Productos Sanitarios

Fuente de la información: Agencia Española de Medicamentos y Productos Sanitarios www.aemps.gob.es; CIMA medicamentos, acquired 11 October 2026 UTC; each source response/update date retained.

Licence: AEMPS explicit public open-data reuse for citizens and companies; source attribution and update date required · Added 12 Oct 2026

Report an error or request removalCorrections from the holder or the register are welcome.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Active substance: Obeticholic acid
Strength: 5 mg
Dosage form: comprimido recubierto con película
Route: vía oral
Register: Spain (AEMPS)
Status: Withdrawn
Status in the register: Revocado
Authorised: 31 Jan 2017
Registration: 1161139001
Marketing authorisation holder: Advanz Pharma Limited
Procedure: EU centralised
Supply: Diagnóstico Hospitalario
EU number: EU/1/16/1139