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.
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List item
Vemlidy : EPAR - Summary for the public (PDF/78.83 KB)
First published: 10/03/2017
Last updated: 10/03/2017
EMA/788418/2016 -
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List item
Vemlidy : EPAR - Risk-management-plan summary (PDF/182.58 KB)
First published: 18/08/2021
Last updated: 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 |
Product information
26/05/2023 Vemlidy - EMEA/H/C/004169 - II/0040
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
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).