Emtricitabine/Tenofovir disoproxil Mylan

emtricitabine / tenofovir disoproxil

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This is a summary of the European public assessment report (EPAR) for Emtricitabine/Tenofovir disoproxil Mylan. 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 Emtricitabine/Tenofovir disoproxil Mylan.

For practical information about using Emtricitabine/Tenofovir disoproxil Mylan, patients should read the package leaflet or contact their doctor or pharmacist.

What is Emtricitabine/Tenofovir disoproxil Mylan and what is it used for?

Emtricitabine/Tenofovir disoproxil Mylan is an antiviral medicine that is used in combination with at least one other antiviral medicine to treat adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).

Emtricitabine/Tenofovir disoproxil Mylan contains two active substances, emtricitabine and tenofovir disoproxil. It is a ‘generic medicine’. This means that it is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Truvada.

How is Emtricitabine/Tenofovir disoproxil Mylan used?

Emtricitabine/Tenofovir disoproxil Mylan can only be obtained with a prescription and treatment should be started by a doctor who has experience in the management of HIV infection.

Emtricitabine/Tenofovir disoproxil Mylan is available as tablets (200 mg emtricitabine and 245 mg tenofovir disoproxil). The recommended dose is one tablet once a day, preferably taken with food. If patients need to stop taking emtricitabine or tenofovir, or need to take different doses, they will need to take medicines containing emtricitabine or tenofovir disoproxil separately.

For more information, see the package leaflet.

How does Emtricitabine/Tenofovir disoproxil Mylan work?

Emtricitabine/Tenofovir disoproxil Mylan contains two active substances: emtricitabine, which is a nucleoside reverse transcriptase inhibitor; and tenofovir disoproxil, which is a ‘prodrug’ of tenofovir. This means that it is converted into tenofovir in the body. Tenofovir is a nucleotide reverse transcriptase inhibitor. Both emtricitabine and tenofovir work in similar ways by blocking the activity of reverse transcriptase, an enzyme produced by HIV that allows it to reproduce itself in the cells it has infected.

Emtricitabine/Tenofovir disoproxil Mylan, taken in combination with at least one other antiviral medicine, reduces the amount of HIV in the blood and keeps it at a low level. Emtricitabine/Tenofovir disoproxil Mylan does not cure HIV infection or AIDS, but it may hold off the damage to the immune system and the development of infections and diseases associated with AIDS.

How has Emtricitabine/Tenofovir disoproxil Mylan been studied?

Because Emtricitabine/Tenofovir disoproxil Mylan is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Truvada. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the benefits and risks of Emtricitabine/Tenofovir disoproxil Mylan?

Because Emtricitabine/Tenofovir disoproxil Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

Why is Emtricitabine/Tenofovir disoproxil Mylan approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Emtricitabine/Tenofovir disoproxil Mylan has been shown to have comparable quality and to be bioequivalent to Truvada. Therefore, the CHMP’s view was that, as for Truvada, the benefit outweighs the identified risk. The Committee recommended that Emtricitabine/Tenofovir disoproxil Mylan be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Emtricitabine/Tenofovir disoproxil Mylan?

The company that markets Emtricitabine/Tenofovir disoproxil Mylan will provide an information pack to doctors which covers the risk of kidney disease with Emtricitabine/Tenofovir disoproxil Mylan.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Emtricitabine/Tenofovir disoproxil Mylan have also been included in the summary of product characteristics and the package leaflet.

Other information about Emtricitabine/Tenofovir disoproxil Mylan

The European Commission granted a marketing authorisation valid throughout the European Union for Emtricitabine/Tenofovir disoproxil Mylan on 16 December 2016.

For more information about treatment with Emtricitabine/Tenofovir disoproxil Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Summary for the public BG = bălgarski 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Summary for the public ES = español 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Summary for the public CS = čeština 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Summary for the public DA = dansk 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Summary for the public DE = Deutsch 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Summary for the public ET = eesti keel 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Summary for the public EL = elliniká 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Summary for the public EN = English 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Summary for the public FR = français 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Summary for the public IT = italiano 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Summary for the public LV = latviešu valoda 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Summary for the public LT = lietuvių kalba 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Summary for the public HU = magyar 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Summary for the public MT = Malti 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Summary for the public NL = Nederlands 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Summary for the public PL = polski 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Summary for the public PT = português 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Summary for the public RO = română 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Summary for the public SK = slovenčina 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Summary for the public SL = slovenščina 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Summary for the public FI = suomi 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Summary for the public SV = svenska 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Summary for the public HR = Hrvatski 2017-02-03  

This EPAR was last updated on 03/02/2017 .

Authorisation details

Product details

Product details for Emtricitabine/Tenofovir disoproxil Mylan
NameEmtricitabine/Tenofovir disoproxil Mylan
Agency product numberEMEA/H/C/004050
Active substance

emtricitabine / tenofovir disoproxil maleate

International non-proprietary name (INN) or common name

emtricitabine / tenofovir disoproxil

Therapeutic area HIV Infections
Anatomical therapeutic chemical (ATC) code J05AR03
Generic

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Publication details

Publication details for Emtricitabine/Tenofovir disoproxil Mylan
Marketing-authorisation holder

Mylan S.A.S

Revision0
Date of issue of marketing authorisation valid throughout the European Union16/12/2016

Contact address:

Mylan S.A.S
117 Allee des Parcs
69800 Saint Priest
France

Product information

Product information

16/12/2016  Emtricitabine/Tenofovir disoproxil Mylan -EMEA/H/C/004050

Name Language First published Last updated
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Product Information HR = Hrvatski 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Product Information HR = Hrvatski 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Product Information HR = Hrvatski 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Product Information HR = Hrvatski 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Product Information HR = Hrvatski 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Product Information HR = Hrvatski 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Product Information HR = Hrvatski 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Product Information HR = Hrvatski 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Product Information HR = Hrvatski 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Product Information HR = Hrvatski 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Product Information HR = Hrvatski 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Product Information HR = Hrvatski 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Product Information HR = Hrvatski 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Product Information HR = Hrvatski 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Product Information HR = Hrvatski 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Product Information HR = Hrvatski 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Product Information HR = Hrvatski 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Product Information HR = Hrvatski 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Product Information HR = Hrvatski 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Product Information HR = Hrvatski 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Product Information HR = Hrvatski 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Product Information HR = Hrvatski 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Product Information HR = Hrvatski 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Product Information HR = Hrvatski 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Product Information HR = Hrvatski 2017-02-03  

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
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-02-03  

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Emtricitabine/Tenofovir disoproxil Mylan is indicated in antiretroviral combination therapy for the treatment of HIV 1 infected adults.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Public assessment report HR = Hrvatski 2017-02-03  
CHMP summary of positive opinion for Emtricitabine/Tenofovir disoproxil Mylan HR = Hrvatski 2016-10-14