Oxynal Targin and associated names
- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
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 |
European Commission final decision
|
Opinion date |
23/10/2014
|
EC decision date |
22/12/2014
|
All documents
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Questions and answers on Oxynal, Targin and associated names (oxycodone hydrochloride / naloxone hydrochloride) (PDF/75.56 KB)
Adopted
First published: 24/10/2014
Last updated: 27/01/2015
EMA/653836/2014 -
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Oxynal, Targin Article-13 referral - Assessment report (PDF/258.04 KB)
First published: 27/01/2015
Last updated: 27/01/2015
EMA/707185/2014 -
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Oxynal, Targin Article-13 referral - Annex I (PDF/244.21 KB)
First published: 27/01/2015
Last updated: 27/01/2015 -
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Oxynal, Targin Article-13 referral - Annex II (PDF/58.49 KB)
First published: 27/01/2015
Last updated: 27/01/2015 -
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Oxynal, Targin Article-13 referral - Annex III (PDF/38.52 KB)
First published: 27/01/2015
Last updated: 27/01/2015 -
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