Oxynal-Targin and associated names

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
Current status:
Opinion provided by Committee for Medicinal Products for Human Use

Overview

On 23 October 2014, the European Medicines Agency completed an arbitration procedure for Oxynal, Targin and associated names. The Agency's Committee for Medicinal Products for Human Use (CHMP) had been asked to arbitrate on a change to the marketing authorisation for these medicines to include a new use in the treatment of restless legs syndrome. The Committee concluded that the benefits of Oxynal, Targin and associated names outweigh their risks in the new use and the change to the marketing authorisation can be granted in Germany and the following Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Hungary, Ireland, Italy, Latvia, Luxembourg, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom.

Key facts

Approved name
Oxynal-Targin and associated names
International non-proprietary name (INN) or common name
oxycodone hydrochloride / naloxone hydrochloride
Reference number
EMEA/H/A-13/1402
Type
Article 13 referrals

This type of referral is triggered for a medicine that has been authorised by mutual recognition or via the decentralised procedure when there is disagreement between Member States on a variation (type II), on the grounds of a potential serious risk to public health.

Status
Opinion provided by Committee for Medicinal Products for Human Use
Opinion date
23/10/2014
EC decision date
22/12/2014

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:

How useful was this page?

Add your rating
Average
1 rating