Is Enfuvirtide approved by the US FDA?

Drugs@FDA lists 1 application product line for Enfuvirtide, including FUZEON (Discontinued).

Is Enfuvirtide authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Enfuvirtide: Fuzeon.

Are there safety signals or safety updates for Enfuvirtide?

EMA PRAC: 3 entries; US FDA: 1 entry (latest 2018-12-27).

Active substance

Enfuvirtide

US FDA 1
EMA 1
Safety 4

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
FUZEON	90MG/VIAL	injectable · subcutaneous	ROCHE	Discontinued	13 Mar 2003

EMA European Union — centrally authorised medicines

Fuzeon Roche Registration GmbH · Authorised · authorised 27 May 2003 · ATC J05AX07

Therapeutic indication (EMA)

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.

Safety signals and safety-related labeling changes

US FDA 27 Dec 2018 FUZEON — safety-related labeling change
Labeling sections changed: Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 12 Jul 2018 PRAC signal: Autoimmune hepatitis
Action for MAH: update of the product information: Yes
EMA PRAC 8 Mar 2018 PRAC signal: Autoimmune hepatitis
Action for MAH: update of the product information: No
EMA PRAC 11 Jun 2015 PRAC signal: Amyloidosis
Action for MAH: update of the product information: No

All safety entries for enfuvirtide →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.