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 06/06/2018

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
Marketing-authorisation holder
Gilead Sciences Ireland UC
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
09/01/2017
Contact address
Carrigtohill
County Cork, T45 DP77
Ireland

Product information

28/05/2018 Vemlidy - EMEA/H/C/004169 - T/0013

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).

Assessment history

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