This medicine is authorised for use in the European Union.


PecFent is a medicine used to treat breakthrough pain in adult patients with cancer. Breakthrough pain is when a patient experiences additional, sudden pain in spite of ongoing treatment with painkillers.

PecFent is used in patients who are already using opioids (a group of painkillers that includes morphine and fentanyl) to control long-term cancer pain.

PecFent is a ‘hybrid medicine’. This means that it is similar to ‘reference medicines’ containing the same active substance, but given in a different way. While the reference medicines Effentora (buccal tablets) and Actiq (lozenges) are taken by mouth, PecFent is given as a spray into the nose.

PecFent contains the active substance fentanyl.

This EPAR was last updated on 08/11/2022

Authorisation details

Product details
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
  • Pain
  • Cancer
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Kyowa Kirin Holdings B.V.
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Bloemlaan 2
2132NP Hoofddorp
The Netherlands

Product information

29/09/2022 PecFent - EMEA/H/C/001164 - II/0054

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You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group


Therapeutic 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.

Assessment history

Changes since initial authorisation of medicine

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