PecFent
fentanyl
Table of contents
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.
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List item
PecFent : EPAR - Summary for the public (PDF/84.16 KB)
First published: 14/09/2010
Last updated: 03/08/2018 -
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List item
PecFent : EPAR - Risk management plan summary (PDF/817.16 KB)
First published: 08/11/2022
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) |
|
Anatomical therapeutic chemical (ATC) code |
N02AB03
|
Publication details | |
---|---|
Marketing-authorisation holder |
Kyowa Kirin Holdings B.V.
|
Revision |
23
|
Date of issue of marketing authorisation valid throughout the European Union |
31/08/2010
|
Contact address |
Bloemlaan 2 |
Product information
29/09/2022 PecFent - EMEA/H/C/001164 - II/0054
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
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.