🇪🇺 Fentanyl Buccal Tablet (FBT) in European Union

EMA authorised Fentanyl Buccal Tablet (FBT) on 4 April 2008

Marketing authorisation

EMA — authorised 4 April 2008

  • Application: EMEA/H/C/000833
  • Marketing authorisation holder: Phoenix Labs Unlimited Company
  • Local brand name: Effentora
  • Indication: Effentora is indicated for the treatment of breakthrough pain (BTP) in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain. BTP 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 equianalgesic dose of another opioid for a week or longer.
  • Status: approved

Read official source →

Fentanyl Buccal Tablet (FBT) in other countries

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

Other Oncology approved in European Union

Frequently asked questions

Is Fentanyl Buccal Tablet (FBT) approved in European Union?

Yes. EMA authorised it on 4 April 2008.

Who is the marketing authorisation holder for Fentanyl Buccal Tablet (FBT) in European Union?

Phoenix Labs Unlimited Company holds the EU marketing authorisation.