Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan

efavirenz / emtricitabine / tenofovir disoproxil

  • Email
  • Help

About

This is a summary of the European public assessment report (EPAR) for Efavirenz/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 the medicine.

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

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

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

It is only used in patients who have responded well to their current HIV treatment and who do not have an HIV infection that is resistant to treatment or not likely to respond to any of the active substances in the medicine.

The medicine contains the active substances efavirenz, emtricitabine and tenofovir disoproxil and is a ‘generic medicine’. This means that it contains the same active substances and works in the same way as a ‘reference medicine’ already authorised in the European Union (EU) called Atripla.

How is the medicine used?

This medicine is available as tablets and can only be obtained with a prescription. Treatment should be started by a doctor who has experience in the management of HIV infection. The recommended dose is one tablet daily, swallowed whole with water. It is recommended that the medicine be taken on an empty stomach, preferably at bedtime. Patients should take the medicine regularly and avoid missing doses.

If patients need to stop taking one of the active substances in the medicine, or need to take different doses, they will need to change to separate individual medicines. This medicine should not be taken at the same time as other medicines that contain efavirenz, emtricitabine or tenofovir disoproxil, or lamivudine (another antiviral medicine). For more information, see the package leaflet.

How does it work?

This medicine contains three active substances: efavirenz, which is a non-nucleoside reverse transcriptase inhibitor (NNRTI); emtricitabine, which is a nucleoside reverse transcriptase inhibitor; and tenofovir disoproxil, which is a ‘prodrug’ of tenofovir, meaning that it is converted into the active substance tenofovir in the body. Tenofovir is a nucleotide reverse transcriptase inhibitor. Both nucleoside and nucleotide reverse transcriptase inhibitors are commonly known as NRTIs. All three active substances block the activity of reverse transcriptase, an enzyme that allows HIV to reproduce itself in the cells it has infected.

Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan keeps the amount of HIV in the blood at a low level. It 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 the medicine been studied?

Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Atripla, and do not need to be repeated for Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan.

As for every medicine, the company provided studies on its quality. The company also carried out a study that showed that the medicine is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the benefits and risks of this medicine?

Because Efavirenz/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 the medicine approved?

The European Medicines Agency concluded that, in accordance with EU requirements, the medicine has been shown to have comparable quality and to be bioequivalent to Atripla. Therefore, the Agency’s view was that, as for Atripla, the benefit outweighs the identified risk. The Agency recommended that it be approved for use in the EU.

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

The company that markets the medicine will ensure that all doctors expected to prescribe the medicine are provided with an educational pack that includes information on the increased risk of kidney disease with medicines containing tenofovir disoproxil such as this one. The educational pack also contains recommendations for monitoring kidney function in patients taking the medicine.

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

Other information about Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan

The European Commission granted a marketing authorisation valid throughout the European Union for Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan on 5 September 2017.

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

Name Language First published Last updated
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Summary for the public BG = bălgarski 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Summary for the public ES = español 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Summary for the public CS = čeština 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Summary for the public DA = dansk 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Summary for the public DE = Deutsch 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Summary for the public ET = eesti keel 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Summary for the public EL = elliniká 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Summary for the public EN = English 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Summary for the public FR = français 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Summary for the public IT = italiano 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Summary for the public LV = latviešu valoda 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Summary for the public LT = lietuvių kalba 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Summary for the public HU = magyar 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Summary for the public MT = Malti 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Summary for the public NL = Nederlands 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Summary for the public PL = polski 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Summary for the public PT = português 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Summary for the public RO = română 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Summary for the public SK = slovenčina 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Summary for the public SL = slovenščina 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Summary for the public FI = suomi 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Summary for the public SV = svenska 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Summary for the public HR = Hrvatski 2017-11-21  

This EPAR was last updated on 21/11/2017 .

Authorisation details

Product details

Product details for Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan
NameEfavirenz/Emtricitabine/Tenofovir disoproxil Mylan
Agency product numberEMEA/H/C/004240
Active substance

efavirenz / emtricitabine / tenofovir disoproxil maleate

International non-proprietary name (INN) or common name

efavirenz / emtricitabine / tenofovir disoproxil

Therapeutic area HIV Infections
Anatomical therapeutic chemical (ATC) code J05AR06
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 Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan
Marketing-authorisation holder

Mylan S.A.S

Revision0
Date of issue of marketing authorisation valid throughout the European Union05/09/2017

Contact address:

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

Product information

Product information

05/09/2017  Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan -EMEA/H/C/004240 --

Name Language First published Last updated
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Product Information HR = Hrvatski 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Product Information HR = Hrvatski 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Product Information HR = Hrvatski 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Product Information HR = Hrvatski 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Product Information HR = Hrvatski 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Product Information HR = Hrvatski 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Product Information HR = Hrvatski 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Product Information HR = Hrvatski 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Product Information HR = Hrvatski 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Product Information HR = Hrvatski 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Product Information HR = Hrvatski 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Product Information HR = Hrvatski 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Product Information HR = Hrvatski 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Product Information HR = Hrvatski 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Product Information HR = Hrvatski 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Product Information HR = Hrvatski 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Product Information HR = Hrvatski 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Product Information HR = Hrvatski 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Product Information HR = Hrvatski 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Product Information HR = Hrvatski 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Product Information HR = Hrvatski 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Product Information HR = Hrvatski 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Product Information HR = Hrvatski 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Product Information HR = Hrvatski 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Product Information HR = Hrvatski 2017-11-21  

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
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-11-21  
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan : EPAR - All Authorised presentations HR = Hrvatski 2017-11-21  

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan is a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil. It is indicated for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years and over with virologic suppression to HIV-1 RNA levels of < 50 copies/ml on their current combination antiretroviral therapy for more than three months. Patients must not have experienced virological failure on any prior antiretroviral therapy and must be known not to have harboured virus strains with mutations conferring significant resistance to any of the three components contained in Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan prior to initiation of their first antiretroviral treatment regimen.

The demonstration of the benefit of efavirenz/emtricitabine/tenofovir disoproxil is primarily based on 48-week data from a clinical study in which patients with stable virologic suppression on a combination antiretroviral therapy changed to efavirenz/emtricitabine/tenofovir disoproxil (see section 5.1). No data are currently available from clinical studies with efavirenz/emtricitabine/tenofovir disoproxil in treatment-naïve or in heavily pretreated patients.

No data are available to support the combination of efavirenz/emtricitabine/tenofovir disoproxil and other antiretroviral agents.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Authorised

This medicine is approved for use in the European Union

More information on Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan