Orlistat

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
Current status:
European Commission final decision

Overview

The European Medicines Agency has completed a review of orlistat-containing medicines, following concerns about the possible risk of severe liver injury with these medicines. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of orlistat continue to outweigh its risks, and recommended that the marketing authorisations be maintained with minor amendments to the product information to ensure the same information on very rare liver-related side effects is provided for all orlistat-containing medicines.

Key facts

Approved name
Orlistat
International non-proprietary name (INN) or common name
orlistat
Class
-
Reference number
EMEA/H/A-31/1318
Type
Article 31 referrals

This type of referral is triggered when the interest of the Union is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.

Status
European Commission final decision
Opinion date
16/02/2012
EC decision date
24/04/2012

All documents

Document description

  • Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
  • Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
  • List of the medicines affected by the referral (Annex I)
  • Scientific conclusions of the Committee (Annex II)

The following two documents are sometimes available:

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