Modified-released oral opioids

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

Overview

Outcome of a procedure under Article 31 of Directive 2001/83/EC as amended

The European Medicines Agency has completed a review of the safety and effectiveness of modified-release oral opioid medicines of the WHO level III scale for the management of pain. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of most of these medicines continue to outweigh their risks, but that warnings on the use of these medicines together with alcohol should be made consistent across the class.

However, for modified-release medicines that contain a 'polymethacrylate-triethylcitrate controlled release system', the Committee concluded that the marketing authorisations should be suspended. These suspensions will remain in force until the companies that make these medicines have reformulated them so that they are more stable in alcohol.

After re-examination, the Committee confirmed these recommendations on 18 November 2010.

Key facts

Approved name
Modified-released oral opioids
International non-proprietary name (INN) or common name
hydromorphone, morphine and oxycodone
Class
Opioids of the World Health Organization level III scale
Reference number
EMEA/H/A-31/001232
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
18/11/2010
EC decision date
20/04/2011

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:

  • Changes to the summary of product characteristics, labeling or package leaflet (also known as Annex III) - available when changes havebeen recommended by the Committee
  • Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be takenfor the marketing authorisation(s) such as safety measures or extra studies

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