🇪🇺 fentanyl transmucosal in European Union

EMA authorised fentanyl transmucosal on 31 August 2010

Marketing authorisation

EMA — authorised 31 August 2010

  • Application: EMEA/H/C/001164
  • Marketing authorisation holder: Gruenenthal GmbH
  • Local brand name: PecFent
  • Indication: PecFent is indicated for the management of breakthrough pain in adults who are already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain. Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equi-analgesic dose of another opioid for a week or longer.
  • Status: approved

Read official source →

fentanyl transmucosal in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is fentanyl transmucosal approved in European Union?

Yes. EMA authorised it on 31 August 2010.

Who is the marketing authorisation holder for fentanyl transmucosal in European Union?

Gruenenthal GmbH holds the EU marketing authorisation.