PecFent

RSS

fentanyl

Authorised
This medicine is authorised for use in the European Union.

Overview

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 07/11/2019

Authorisation details

Product details
Name
PecFent
Agency product number
EMEA/H/C/001164
Active substance
fentanyl
International non-proprietary name (INN) or common name
fentanyl
Therapeutic area (MeSH)
  • Pain
  • Cancer
Anatomical therapeutic chemical (ATC) code
N02AB03
Publication details
Marketing-authorisation holder
Kyowa Kirin Holdings B.V.
Revision
19
Date of issue of marketing authorisation valid throughout the European Union
31/08/2010
Contact address

Bloemlaan 2
2132NP Hoofddorp
The Netherlands

Product information

25/06/2019 PecFent - EMEA/H/C/001164 - IB/0049

Contents

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Pharmacotherapeutic group

ANALGESICS

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

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