Ethirfin

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

Overview

The European Medicines Agency has completed an arbitration procedure for Ethirfin and associated names. The Agency's Committee for Medicinal Products for Human Use (CHMP) had been asked to arbitrate on the renewal of the marketing authorisation for Ethirfin. The Committee concluded that the marketing authorisation should not be renewed, as patients taking Ethirfin and alcohol are at risk of developing serious side effects.

The European Commission issued a decision on this opinion on 20 December 2010.

Key facts

Approved name
Ethirfin
International non-proprietary name (INN) or common name
morphine sulphate
Reference number
EMEA/H/A-29/001248
Type
Article 29(4) referrals

This type of referral is triggered when there is a disagreement between Member States regarding a marketing authorisation application being evaluated in a mutual-recognition or decentralised procedure, on the grounds of a potential serious risk to public health.

Status
European Commission final decision
Opinion date
23/09/2010
EC decision date
20/12/2010

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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