Vemlidy

tenofovir alafenamide

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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.

What is Vemlidy and what is it used for?

Vemlidy is an antiviral medicine for treating chronic (long-term) hepatitis B, an infectious disease that affects the liver.

This medicine is used in patients aged 12 years and older weighing at least 35 kg. It contains the active substance tenofovir alafenamide.

How is Vemlidy used?

Vemlidy is available as 25 mg tablets which are taken by mouth (one tablet a day) with food.The patient will usually take their medicine for at least 6 to 12 months, and treatment may last several years.

Vemlidy can only be obtained with a prescription.

How does Vemlidy work?

The active substance in Vemlidy, tenofovir alafenamide, works by stopping the hepatitis B virus in the liver from multiplying. It is converted in the body into its active compound tenofovir, which blocks the activity of reverse transcriptase, an enzyme made by the hepatitis B virus that allows it to reproduce itself in the cells it has infected.

What benefits of Vemlidy have been shown in studies?

Vemlidy reduces levels of hepatitis B virus in most patients. In a study of 426 patients with ‘e-antigen negative’ chronic hepatitis, 94% of patients on Vemlidy had very low levels of viral DNA after 48 weeks of treatment. This result was similar to that in patients taking another form of tenofovir (tenofovir disoproxil fumarate) where 93% had very low viral DNA levels.

In a second study of 875 patients with ‘e-antigen positive’ chronic hepatitis, 64% of patients taking Vemlidy and 67% of those taking tenofovir disoproxil fumarate had very low levels of viral DNA after 48 weeks. These results suggest that the comparator medicine might be more effective in ‘e-antigen positive’ cases but differences seen are small.

The terms ‘e-antigen positive’ and ‘e-antigen negative’ refer to the presence or absence of e-antigen, a hepatitis B viral protein. If this protein is present, it means that the virus is multiplying rapidly and the viral load may be higher.

What are the risks associated with Vemlidy?

The most common side effects with Vemlidy are headache (11% of patients), nausea (6% of patients) and tiredness (6% of patients). For the full list of side effects and restrictions see the package leaflet.

Why is Vemlidy approved?

Vemlidy suppresses levels of hepatitis B virus in the body, and its effectiveness is comparable to that of another tenofovir medicine (tenofovir disoproxil fumarate). With regard to its risks, the side effects of Vemlidy are manageable. In addition, Vemlidy is effective at a lower dose than tenofovir disoproxil fumarate and may lead to reduced side effects in the kidneys and bones.

The Agency’s Committee for Medicinal Products for Human Use (CHMP) therefore concluded that the benefits of Vemlidy outweigh its risks and recommended its approval in the EU.

What measures are being taken to ensure the safe and effective use of Vemlidy?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vemlidy have been included in the summary of product characteristics and the package leaflet.

Other information about Vemlidy

The European Commission granted a marketing authorisation valid throughout the European Union for Vemlidy on 9 January 2017.

For more information about treatment with Vemlidy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Vemlidy : EPAR - Summary for the public BG = bălgarski 2017-03-10  
Vemlidy : EPAR - Summary for the public ES = español 2017-03-10  
Vemlidy : EPAR - Summary for the public CS = čeština 2017-03-10  
Vemlidy : EPAR - Summary for the public DA = dansk 2017-03-10  
Vemlidy : EPAR - Summary for the public DE = Deutsch 2017-03-10  
Vemlidy : EPAR - Summary for the public ET = eesti keel 2017-03-10  
Vemlidy : EPAR - Summary for the public EL = elliniká 2017-03-10  
Vemlidy : EPAR - Summary for the public EN = English 2017-03-10  
Vemlidy : EPAR - Summary for the public FR = français 2017-03-10  
Vemlidy : EPAR - Summary for the public IT = italiano 2017-03-10  
Vemlidy : EPAR - Summary for the public LV = latviešu valoda 2017-03-10  
Vemlidy : EPAR - Summary for the public LT = lietuvių kalba 2017-03-10  
Vemlidy : EPAR - Summary for the public HU = magyar 2017-03-10  
Vemlidy : EPAR - Summary for the public MT = Malti 2017-03-10  
Vemlidy : EPAR - Summary for the public NL = Nederlands 2017-03-10  
Vemlidy : EPAR - Summary for the public PL = polski 2017-03-10  
Vemlidy : EPAR - Summary for the public PT = português 2017-03-10  
Vemlidy : EPAR - Summary for the public RO = română 2017-03-10  
Vemlidy : EPAR - Summary for the public SK = slovenčina 2017-03-10  
Vemlidy : EPAR - Summary for the public SL = slovenščina 2017-03-10  
Vemlidy : EPAR - Summary for the public FI = suomi 2017-03-10  
Vemlidy : EPAR - Summary for the public SV = svenska 2017-03-10  
Vemlidy : EPAR - Summary for the public HR = Hrvatski 2017-03-10  

This EPAR was last updated on 10/03/2017 .

Authorisation details

Product details

Product details for Vemlidy
NameVemlidy
Agency product numberEMEA/H/C/004169
Active substance

tenofovir alafenamide fumarate

International non-proprietary name (INN) or common name

tenofovir alafenamide

Therapeutic area Hepatitis B
Anatomical therapeutic chemical (ATC) code J05AF
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Vemlidy
Marketing-authorisation holder

Gilead Sciences International Ltd

Revision0
Date of issue of marketing authorisation valid throughout the European Union09/01/2017

Contact address:

Gilead Sciences International Ltd
Granta Park Abington
Cambridge CB21 6GT 
United Kingdom

Product information

Product information

09/01/2017  Vemlidy -EMEA/H/C/004169

Name Language First published Last updated
Vemlidy : EPAR - Product Information HR = Hrvatski 2017-03-10  
Vemlidy : EPAR - Product Information HR = Hrvatski 2017-03-10  
Vemlidy : EPAR - Product Information HR = Hrvatski 2017-03-10  
Vemlidy : EPAR - Product Information HR = Hrvatski 2017-03-10  
Vemlidy : EPAR - Product Information HR = Hrvatski 2017-03-10  
Vemlidy : EPAR - Product Information HR = Hrvatski 2017-03-10  
Vemlidy : EPAR - Product Information HR = Hrvatski 2017-03-10  
Vemlidy : EPAR - Product Information HR = Hrvatski 2017-03-10  
Vemlidy : EPAR - Product Information HR = Hrvatski 2017-03-10  
Vemlidy : EPAR - Product Information HR = Hrvatski 2017-03-10  
Vemlidy : EPAR - Product Information HR = Hrvatski 2017-03-10  
Vemlidy : EPAR - Product Information HR = Hrvatski 2017-03-10  
Vemlidy : EPAR - Product Information HR = Hrvatski 2017-03-10  
Vemlidy : EPAR - Product Information HR = Hrvatski 2017-03-10  
Vemlidy : EPAR - Product Information HR = Hrvatski 2017-03-10  
Vemlidy : EPAR - Product Information HR = Hrvatski 2017-03-10  
Vemlidy : EPAR - Product Information HR = Hrvatski 2017-03-10  
Vemlidy : EPAR - Product Information HR = Hrvatski 2017-03-10  
Vemlidy : EPAR - Product Information HR = Hrvatski 2017-03-10  
Vemlidy : EPAR - Product Information HR = Hrvatski 2017-03-10  
Vemlidy : EPAR - Product Information HR = Hrvatski 2017-03-10  
Vemlidy : EPAR - Product Information HR = Hrvatski 2017-03-10  
Vemlidy : EPAR - Product Information HR = Hrvatski 2017-03-10  
Vemlidy : EPAR - Product Information HR = Hrvatski 2017-03-10  
Vemlidy : EPAR - Product Information HR = Hrvatski 2017-03-10  

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.


Name Language First published Last updated
Vemlidy : EPAR - All Authorised presentations HR = Hrvatski 2017-03-10  
Vemlidy : EPAR - All Authorised presentations HR = Hrvatski 2017-03-10  
Vemlidy : EPAR - All Authorised presentations HR = Hrvatski 2017-03-10  
Vemlidy : EPAR - All Authorised presentations HR = Hrvatski 2017-03-10  
Vemlidy : EPAR - All Authorised presentations HR = Hrvatski 2017-03-10  
Vemlidy : EPAR - All Authorised presentations HR = Hrvatski 2017-03-10  
Vemlidy : EPAR - All Authorised presentations HR = Hrvatski 2017-03-10  
Vemlidy : EPAR - All Authorised presentations HR = Hrvatski 2017-03-10  
Vemlidy : EPAR - All Authorised presentations HR = Hrvatski 2017-03-10  
Vemlidy : EPAR - All Authorised presentations HR = Hrvatski 2017-03-10  
Vemlidy : EPAR - All Authorised presentations HR = Hrvatski 2017-03-10  
Vemlidy : EPAR - All Authorised presentations HR = Hrvatski 2017-03-10  
Vemlidy : EPAR - All Authorised presentations HR = Hrvatski 2017-03-10  
Vemlidy : EPAR - All Authorised presentations HR = Hrvatski 2017-03-10  
Vemlidy : EPAR - All Authorised presentations HR = Hrvatski 2017-03-10  
Vemlidy : EPAR - All Authorised presentations HR = Hrvatski 2017-03-10  
Vemlidy : EPAR - All Authorised presentations HR = Hrvatski 2017-03-10  
Vemlidy : EPAR - All Authorised presentations HR = Hrvatski 2017-03-10  
Vemlidy : EPAR - All Authorised presentations HR = Hrvatski 2017-03-10  
Vemlidy : EPAR - All Authorised presentations HR = Hrvatski 2017-03-10  
Vemlidy : EPAR - All Authorised presentations HR = Hrvatski 2017-03-10  
Vemlidy : EPAR - All Authorised presentations HR = Hrvatski 2017-03-10  
Vemlidy : EPAR - All Authorised presentations HR = Hrvatski 2017-03-10  
Vemlidy : EPAR - All Authorised presentations HR = Hrvatski 2017-03-10  
Vemlidy : EPAR - All Authorised presentations HR = Hrvatski 2017-03-10  

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

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Vemlidy : EPAR - Public assessment report HR = Hrvatski 2017-03-10  
CHMP summary of positive opinion for Vemlidy HR = Hrvatski 2016-11-11  

Authorised

This medicine is approved for use in the European Union