Vemlidy

RSS

tenofovir alafenamide

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

Overview

This is a summary of the European public assessment report (EPAR) for Vemlidy. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Vemlidy.

For practical information about using Vemlidy, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 31/05/2023

Authorisation details

Product details
Name
Vemlidy
Agency product number
EMEA/H/C/004169
Active substance
tenofovir alafenamide fumarate
International non-proprietary name (INN) or common name
tenofovir alafenamide
Therapeutic area (MeSH)
Hepatitis B
Anatomical therapeutic chemical (ATC) code
J05AF13
Publication details
Marketing-authorisation holder
Gilead Sciences Ireland UC
Revision
16
Date of issue of marketing authorisation valid throughout the European Union
09/01/2017
Contact address

IDA Business & Technology Park
Carrigtohill
County Cork
T45 DP77
Ireland

Product information

26/05/2023 Vemlidy - EMEA/H/C/004169 - II/0040

Other EU languages available icon 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:

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

Vemlidy is indicated for the treatment of chronic hepatitis B (CHB) in adults and paediatric patients 6 years of age and older weighing at least 25 kg (see section 5.1).

Assessment history

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