Pharmaceuticals - Community Register


List of nationally authorised medicinal products for human use

fentanyl Art 107b

Product name: fentanyl Art 107b
Also marketed in the EU under the name(s): Abstral, Actiq, Apacs, Avaric, Breakyl, Buquel, Effentora, Fentanilo Placasod, Fentanyl, Fentanyl Ethypharm, Fentanyl Grunenthal, Fentanyl Hexal, Fentasub, Fentelene, Instanyl, Lunaldin, PecFent, Recivit, Vellofent
Active substance: fentanyl
Indication: Treatment of breakthrough pain (BTP) in patients with cancer who are already receiving maintenance opioid therapy for chronic cancer pain.
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
16/04/2015 PSUSA - Modification EMEA/H/C/PSUSA/1369/201404 (2015)2617 of 15/04/2015
20/07/2015 Rectificative Decision (2015)5148 of 17/07/2015