Effentora
fentanyl
Table of contents
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.
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) |
|
Anatomical therapeutic chemical (ATC) code |
N02AB03
|
Publication details | |
---|---|
Marketing-authorisation holder |
Teva B.V.
|
Revision |
23
|
Date of issue of marketing authorisation valid throughout the European Union |
04/04/2008
|
Contact address |
Swensweg 5 |
Product information
07/04/2021 Effentora - EMEA/H/C/000833 - PSUSA/00001369/202004
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.