Effentora

RSS

fentanyl

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

Overview

This is a summary of the European public assessment report (EPAR) for Effentora. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Effentora.

This EPAR was last updated on 26/07/2018

Authorisation details

Product details
Name
Effentora
Agency product number
EMEA/H/C/000833
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
Teva B.V.
Revision
20
Date of issue of marketing authorisation valid throughout the European Union
03/04/2008
Contact address

Swensweg 5
2031GA Haarlem
The Netherlands

Product information

31/05/2018 Effentora - EMEA/H/C/000833 - WS/1273/G

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

ANALGESICS

Therapeutic 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.

Assessment history

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