Oxynal-Targin and associated names

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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.

What are Oxynal and Targin?

Oxynal and Targin are medicines used to treat severe pain that can only be managed with opioids.

Oxynal and Targin contain two active substances: oxycodone hydrochloride, an opioid painkiller, and naloxone hydrochloride, an opioid antagonist, which is added to counteract opioid-induced constipation by blocking the action of oxycodone at opioid receptors found locally in the gut.

Oxynal, Targin and associated names are marketed in all EU Member States except Croatia, Greece, Lithuania and Malta. The company that markets these medicines is Mundipharma GmbH.

Why was Oxynal and Targin reviewed?

Oxynal and Targin are medicines used to treat severe pain that can only be managed with opioids.

Oxynal and Targin contain two active substances: oxycodone hydrochloride, an opioid painkiller, and naloxone hydrochloride, an opioid antagonist, which is added to counteract opioid-induced constipation by blocking the action of oxycodone at opioid receptors found locally in the gut.

Oxynal, Targin and associated names are marketed in all EU Member States except Croatia, Greece, Lithuania and Malta. The company that markets these medicines is Mundipharma GmbH.

What are the conclusions of the CHMP?

Oxynal and Targin have been authorised in the EU under a mutual recognition procedure based on an initial authorisation granted by Germany. In November 2012, the company for Oxynal and Targin applied for an additional use in Germany: treatment of symptoms of severe to very severe restless legs syndrome when treatment with other medicines called dopaminergics has failed. Restless legs syndrome is a disorder where the patient has uncontrollable urges to move the limbs to stop uncomfortable, painful or odd sensations in the body, usually at night.

The company wanted the authorisation for the additional use in restless legs syndrome to be recognised in 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 (the ‘concerned Member States’). However, the Member States were unable to reach agreement on whether to accept this new indication and on 2 May 2014, Germany referred the matter to the CHMP for arbitration.

The grounds for the referral were concerns from the Netherlands that the data on Oxynal and Targin submitted in the application were not sufficient to demonstrate a positive benefit-risk balance in restless legs syndrome. In particular, there were concerns that the use of Oxynal and Targin could lead to tolerance and misuse and that this was not adequately studied in the clinical trial and the proposed measures to reduce the risk of tolerance and misuse were not considered sufficient.

What are the conclusions of the CHMP?

The Committee looked at the study presented by the company to support its application. Based on the evaluation of the available data and the scientific discussion within the Committee, the CHMP agreed that the study had convincingly shown that Oxynal and Targin are beneficial in the treatment of symptoms of severe to very severe restless legs syndrome when standard therapy has failed. Regarding the safety, the CHMP concluded that overall the risk of tolerance and misuse is considered low and that the proposed measures to reduce this risk are appropriate.

The CHMP therefore concluded that the benefits of Oxynal and Targin for restless legs syndrome outweigh their risks and recommended that the change to the marketing authorisation be granted in Germany and the concerned Member States.

The European Commission issued an EU-wide legally binding decision to implement this change on 22 December 2014.

Name Language First published Last updated
Questions and answers on Oxynal, Targin and associated names (oxycodone hydrochloride / naloxone hydrochloride) BG = bălgarski 2014-10-24 2015-01-27
Questions and answers on Oxynal, Targin and associated names (oxycodone hydrochloride / naloxone hydrochloride) ES = español 2014-10-24 2015-01-27
Questions and answers on Oxynal, Targin and associated names (oxycodone hydrochloride / naloxone hydrochloride) CS = čeština 2014-10-24 2015-01-27
Questions and answers on Oxynal, Targin and associated names (oxycodone hydrochloride / naloxone hydrochloride) DA = dansk 2014-10-24 2015-01-27
Questions and answers on Oxynal, Targin and associated names (oxycodone hydrochloride / naloxone hydrochloride) DE = Deutsch 2014-10-24 2015-01-27
Questions and answers on Oxynal, Targin and associated names (oxycodone hydrochloride / naloxone hydrochloride) ET = eesti keel 2014-10-24 2015-01-27
Questions and answers on Oxynal, Targin and associated names (oxycodone hydrochloride / naloxone hydrochloride) EL = elliniká 2014-10-24 2015-01-27
Questions and answers on Oxynal, Targin and associated names (oxycodone hydrochloride / naloxone hydrochloride) EN = English 2014-10-24 2015-01-27
Questions and answers on Oxynal, Targin and associated names (oxycodone hydrochloride / naloxone hydrochloride) FR = français 2014-10-24 2015-01-27
Questions and answers on Oxynal, Targin and associated names (oxycodone hydrochloride / naloxone hydrochloride) IT = italiano 2014-10-24 2015-01-27
Questions and answers on Oxynal, Targin and associated names (oxycodone hydrochloride / naloxone hydrochloride) LV = latviešu valoda 2014-10-24 2015-01-27
Questions and answers on Oxynal, Targin and associated names (oxycodone hydrochloride / naloxone hydrochloride) LT = lietuvių kalba 2014-10-24 2015-01-27
Questions and answers on Oxynal, Targin and associated names (oxycodone hydrochloride / naloxone hydrochloride) HU = magyar 2014-10-24 2015-01-27
Questions and answers on Oxynal, Targin and associated names (oxycodone hydrochloride / naloxone hydrochloride) MT = Malti 2014-10-24 2015-01-27
Questions and answers on Oxynal, Targin and associated names (oxycodone hydrochloride / naloxone hydrochloride) NL = Nederlands 2014-10-24 2015-01-27
Questions and answers on Oxynal, Targin and associated names (oxycodone hydrochloride / naloxone hydrochloride) PL = polski 2014-10-24 2015-01-27
Questions and answers on Oxynal, Targin and associated names (oxycodone hydrochloride / naloxone hydrochloride) PT = português 2014-10-24 2015-01-27
Questions and answers on Oxynal, Targin and associated names (oxycodone hydrochloride / naloxone hydrochloride) RO = română 2014-10-24 2015-01-27
Questions and answers on Oxynal, Targin and associated names (oxycodone hydrochloride / naloxone hydrochloride) SK = slovenčina 2014-10-24 2015-01-27
Questions and answers on Oxynal, Targin and associated names (oxycodone hydrochloride / naloxone hydrochloride) SL = slovenščina 2014-10-24 2015-01-27
Questions and answers on Oxynal, Targin and associated names (oxycodone hydrochloride / naloxone hydrochloride) FI = suomi 2014-10-24 2015-01-27
Questions and answers on Oxynal, Targin and associated names (oxycodone hydrochloride / naloxone hydrochloride) SV = svenska 2014-10-24 2015-01-27
Questions and answers on Oxynal, Targin and associated names (oxycodone hydrochloride / naloxone hydrochloride) HR = Hrvatski 2014-10-24 2015-01-27

Key facts

Approved nameOxynal-Targin and associated names
International non-proprietary name (INN) or common name

oxycodone hydrochloride / naloxone hydrochloride

Associated names
Class
Reference numberEMEA/H/A-13/1402
TypeArticle 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).

StatusOpinion provided by Committee for Medicinal Products for Human Use
Opinion date23/10/2014

All documents

Name Language First published Last updated
Oxynal, Targin Article-13 referral - Assessment report (English only) 2015-01-27  
Oxynal, Targin Article-13 referral - Annex I BG = bălgarski 2015-01-27  
Oxynal, Targin Article-13 referral - Annex I ES = español 2015-01-27  
Oxynal, Targin Article-13 referral - Annex I CS = čeština 2015-01-27  
Oxynal, Targin Article-13 referral - Annex I DA = dansk 2015-01-27  
Oxynal, Targin Article-13 referral - Annex I DE = Deutsch 2015-01-27  
Oxynal, Targin Article-13 referral - Annex I ET = eesti keel 2015-01-27  
Oxynal, Targin Article-13 referral - Annex I EL = elliniká 2015-01-27  
Oxynal, Targin Article-13 referral - Annex I EN = English 2015-01-27  
Oxynal, Targin Article-13 referral - Annex I FR = français 2015-01-27  
Oxynal, Targin Article-13 referral - Annex I IT = italiano 2015-01-27  
Oxynal, Targin Article-13 referral - Annex I LV = latviešu valoda 2015-01-27  
Oxynal, Targin Article-13 referral - Annex I LT = lietuvių kalba 2015-01-27  
Oxynal, Targin Article-13 referral - Annex I HU = magyar 2015-01-27  
Oxynal, Targin Article-13 referral - Annex I MT = Malti 2015-01-27  
Oxynal, Targin Article-13 referral - Annex I NL = Nederlands 2015-01-27  
Oxynal, Targin Article-13 referral - Annex I PL = polski 2015-01-27  
Oxynal, Targin Article-13 referral - Annex I PT = português 2015-01-27  
Oxynal, Targin Article-13 referral - Annex I RO = română 2015-01-27  
Oxynal, Targin Article-13 referral - Annex I SK = slovenčina 2015-01-27  
Oxynal, Targin Article-13 referral - Annex I SL = slovenščina 2015-01-27  
Oxynal, Targin Article-13 referral - Annex I FI = suomi 2015-01-27  
Oxynal, Targin Article-13 referral - Annex I SV = svenska 2015-01-27  
Oxynal, Targin Article-13 referral - Annex I HR = Hrvatski 2015-01-27  
Oxynal, Targin Article-13 referral - Annex I IS = Islenska 2015-01-27  
Oxynal, Targin Article-13 referral - Annex I NO = Norsk 2015-01-27  
Oxynal, Targin Article-13 referral - Annex II BG = bălgarski 2015-01-27  
Oxynal, Targin Article-13 referral - Annex II ES = español 2015-01-27  
Oxynal, Targin Article-13 referral - Annex II CS = čeština 2015-01-27  
Oxynal, Targin Article-13 referral - Annex II DA = dansk 2015-01-27  
Oxynal, Targin Article-13 referral - Annex II DE = Deutsch 2015-01-27  
Oxynal, Targin Article-13 referral - Annex II ET = eesti keel 2015-01-27  
Oxynal, Targin Article-13 referral - Annex II EL = elliniká 2015-01-27  
Oxynal, Targin Article-13 referral - Annex II EN = English 2015-01-27  
Oxynal, Targin Article-13 referral - Annex II FR = français 2015-01-27  
Oxynal, Targin Article-13 referral - Annex II IT = italiano 2015-01-27  
Oxynal, Targin Article-13 referral - Annex II LV = latviešu valoda 2015-01-27  
Oxynal, Targin Article-13 referral - Annex II LT = lietuvių kalba 2015-01-27  
Oxynal, Targin Article-13 referral - Annex II HU = magyar 2015-01-27  
Oxynal, Targin Article-13 referral - Annex II MT = Malti 2015-01-27  
Oxynal, Targin Article-13 referral - Annex II NL = Nederlands 2015-01-27  
Oxynal, Targin Article-13 referral - Annex II PL = polski 2015-01-27  
Oxynal, Targin Article-13 referral - Annex II PT = português 2015-01-27  
Oxynal, Targin Article-13 referral - Annex II RO = română 2015-01-27  
Oxynal, Targin Article-13 referral - Annex II SK = slovenčina 2015-01-27  
Oxynal, Targin Article-13 referral - Annex II SL = slovenščina 2015-01-27  
Oxynal, Targin Article-13 referral - Annex II FI = suomi 2015-01-27  
Oxynal, Targin Article-13 referral - Annex II SV = svenska 2015-01-27  
Oxynal, Targin Article-13 referral - Annex II HR = Hrvatski 2015-01-27  
Oxynal, Targin Article-13 referral - Annex III BG = bălgarski 2015-01-27  
Oxynal, Targin Article-13 referral - Annex III ES = español 2015-01-27  
Oxynal, Targin Article-13 referral - Annex III CS = čeština 2015-01-27  
Oxynal, Targin Article-13 referral - Annex III DA = dansk 2015-01-27  
Oxynal, Targin Article-13 referral - Annex III DE = Deutsch 2015-01-27  
Oxynal, Targin Article-13 referral - Annex III ET = eesti keel 2015-01-27  
Oxynal, Targin Article-13 referral - Annex III EL = elliniká 2015-01-27  
Oxynal, Targin Article-13 referral - Annex III EN = English 2015-01-27  
Oxynal, Targin Article-13 referral - Annex III FR = français 2015-01-27  
Oxynal, Targin Article-13 referral - Annex III IT = italiano 2015-01-27  
Oxynal, Targin Article-13 referral - Annex III LV = latviešu valoda 2015-01-27  
Oxynal, Targin Article-13 referral - Annex III LT = lietuvių kalba 2015-01-27  
Oxynal, Targin Article-13 referral - Annex III HU = magyar 2015-01-27  
Oxynal, Targin Article-13 referral - Annex III MT = Malti 2015-01-27  
Oxynal, Targin Article-13 referral - Annex III NL = Nederlands 2015-01-27  
Oxynal, Targin Article-13 referral - Annex III PL = polski 2015-01-27  
Oxynal, Targin Article-13 referral - Annex III PT = português 2015-01-27  
Oxynal, Targin Article-13 referral - Annex III RO = română 2015-01-27  
Oxynal, Targin Article-13 referral - Annex III SK = slovenčina 2015-01-27  
Oxynal, Targin Article-13 referral - Annex III SL = slovenščina 2015-01-27  
Oxynal, Targin Article-13 referral - Annex III FI = suomi 2015-01-27  
Oxynal, Targin Article-13 referral - Annex III SV = svenska 2015-01-27  
Oxynal, Targin Article-13 referral - Annex III HR = Hrvatski 2015-01-27  
Oxynal, Targin Article-13 referral - Annex III IS = Islenska 2015-01-27  
Oxynal, Targin Article-13 referral - Annex III NO = Norsk 2015-01-27  
Questions and answers on Oxynal, Targin and associated names (oxycodone hydrochloride / naloxone hydrochloride) BG = bălgarski 2014-10-24 2015-01-27
Questions and answers on Oxynal, Targin and associated names (oxycodone hydrochloride / naloxone hydrochloride) ES = español 2014-10-24 2015-01-27
Questions and answers on Oxynal, Targin and associated names (oxycodone hydrochloride / naloxone hydrochloride) CS = čeština 2014-10-24 2015-01-27
Questions and answers on Oxynal, Targin and associated names (oxycodone hydrochloride / naloxone hydrochloride) DA = dansk 2014-10-24 2015-01-27
Questions and answers on Oxynal, Targin and associated names (oxycodone hydrochloride / naloxone hydrochloride) DE = Deutsch 2014-10-24 2015-01-27
Questions and answers on Oxynal, Targin and associated names (oxycodone hydrochloride / naloxone hydrochloride) ET = eesti keel 2014-10-24 2015-01-27
Questions and answers on Oxynal, Targin and associated names (oxycodone hydrochloride / naloxone hydrochloride) EL = elliniká 2014-10-24 2015-01-27
Questions and answers on Oxynal, Targin and associated names (oxycodone hydrochloride / naloxone hydrochloride) EN = English 2014-10-24 2015-01-27
Questions and answers on Oxynal, Targin and associated names (oxycodone hydrochloride / naloxone hydrochloride) FR = français 2014-10-24 2015-01-27
Questions and answers on Oxynal, Targin and associated names (oxycodone hydrochloride / naloxone hydrochloride) IT = italiano 2014-10-24 2015-01-27
Questions and answers on Oxynal, Targin and associated names (oxycodone hydrochloride / naloxone hydrochloride) LV = latviešu valoda 2014-10-24 2015-01-27
Questions and answers on Oxynal, Targin and associated names (oxycodone hydrochloride / naloxone hydrochloride) LT = lietuvių kalba 2014-10-24 2015-01-27
Questions and answers on Oxynal, Targin and associated names (oxycodone hydrochloride / naloxone hydrochloride) HU = magyar 2014-10-24 2015-01-27
Questions and answers on Oxynal, Targin and associated names (oxycodone hydrochloride / naloxone hydrochloride) MT = Malti 2014-10-24 2015-01-27
Questions and answers on Oxynal, Targin and associated names (oxycodone hydrochloride / naloxone hydrochloride) NL = Nederlands 2014-10-24 2015-01-27
Questions and answers on Oxynal, Targin and associated names (oxycodone hydrochloride / naloxone hydrochloride) PL = polski 2014-10-24 2015-01-27
Questions and answers on Oxynal, Targin and associated names (oxycodone hydrochloride / naloxone hydrochloride) PT = português 2014-10-24 2015-01-27
Questions and answers on Oxynal, Targin and associated names (oxycodone hydrochloride / naloxone hydrochloride) RO = română 2014-10-24 2015-01-27
Questions and answers on Oxynal, Targin and associated names (oxycodone hydrochloride / naloxone hydrochloride) SK = slovenčina 2014-10-24 2015-01-27
Questions and answers on Oxynal, Targin and associated names (oxycodone hydrochloride / naloxone hydrochloride) SL = slovenščina 2014-10-24 2015-01-27
Questions and answers on Oxynal, Targin and associated names (oxycodone hydrochloride / naloxone hydrochloride) FI = suomi 2014-10-24 2015-01-27
Questions and answers on Oxynal, Targin and associated names (oxycodone hydrochloride / naloxone hydrochloride) SV = svenska 2014-10-24 2015-01-27
Questions and answers on Oxynal, Targin and associated names (oxycodone hydrochloride / naloxone hydrochloride) HR = Hrvatski 2014-10-24 2015-01-27

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 have been recommended by the Committee
  • Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be taken for the marketing authorisation(s) such as safety measures or extra studies

Current status:
Opinion provided by Committee for Medicinal Products for Human Use

More information on Oxynal-Targin