Pharmaceuticals - Community Register

  

List of nationally authorised medicinal products for human use

Oxynal-Targin and associated names

Product name: Oxynal-Targin and associated names
Also marketed in the EU under the name(s): Targin, Targinact, Targiniq
Active substance: oxycodone hydrochloride/ naloxone hydrochloride dihydrate
Indication: In Restless Legs Syndrome (RLS), OXN PR is currently indicated in “severe pain, which can be adequately managed only with opioid analgesics”.
Marketing Authorisation Holder: Not applicable

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
23/12/2014 Referral EMEA/H/A-13/1402 (2014)10269 of 22/12/2014