Vemlidy
tenofovir alafenamide
Table of contents
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.
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 |
J05AF
|
Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Publication details | |
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Marketing-authorisation holder |
Gilead Sciences Ireland UC
|
Revision |
5
|
Date of issue of marketing authorisation valid throughout the European Union |
09/01/2017
|
Contact address |
Product information
02/05/2019 Vemlidy - EMEA/H/C/004169 - WS/1566
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
Antivirals for systemic use
Therapeutic indication
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).