Fuzeon
enfuvirtide
Table of contents
Overview
This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.
If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).
Authorisation details
Product details | |
---|---|
Name |
Fuzeon
|
Agency product number |
EMEA/H/C/000514
|
Active substance |
enfuvirtide
|
International non-proprietary name (INN) or common name |
enfuvirtide
|
Therapeutic area (MeSH) |
HIV Infections
|
Anatomical therapeutic chemical (ATC) code |
J05AX07
|
Publication details | |
---|---|
Marketing-authorisation holder |
Roche Registration GmbH
|
Revision |
23
|
Date of issue of marketing authorisation valid throughout the European Union |
27/05/2003
|
Contact address |
Emil-Barell-Strasse 1 |
Product information
22/11/2022 Fuzeon - EMEA/H/C/000514 - IB/0063
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
Antivirals for systemic use
Therapeutic indication
Fuzeon is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1-infected patients who have received treatment with and failed on regimens containing at least one medicinal product from each of the following antiretroviral classes: protease inhibitors, non-nucleoside reverse-transcriptase inhibitors and nucleoside reverse-transcriptase inhibitors, or who have intolerance to previous antiretroviral regimens.
In deciding on a new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different medicinal products. Where available, resistance testing may be appropriate.