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.
Vemlidy : EPAR - Summary for the public (PDF/78.83 KB)
First published: 10/03/2017
Last updated: 10/03/2017
|Agency product number||
tenofovir alafenamide fumarate
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Gilead Sciences Ireland UC
|Date of issue of marketing authorisation valid throughout the European Union||
28/05/2018 Vemlidy - EMEA/H/C/004169 - T/0013
- 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.
Vemlidy is indicated for the treatment of chronic hepatitis B in adults and adolescents (aged 12 years and older with body weight at least 35 kg).