Emtricitabine/Tenofovir disoproxil Zentiva

emtricitabine / tenofovir disoproxil

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

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

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

Emtricitabine/Tenofovir disoproxil Zentiva 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). In addition it may be used from the age of 12 years in adolescents with HIV that is resistant to first-line treatments or who cannot take them because of side effects.

Emtricitabine/Tenofovir disoproxil Zentiva contains two active substances, emtricitabine and tenofovir disoproxil. It 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 Truvada.

How is Emtricitabine/Tenofovir disoproxil Zentiva used?

Emtricitabine/Tenofovir disoproxil Zentiva can only be obtained with a prescription and treatment should be started by a doctor who is experienced in managing HIV infection.

Emtricitabine/Tenofovir disoproxil Zentiva is available as tablets (200 mg emtricitabine and 245 mg tenofovir disoproxil). The recommended dose is one tablet a day, 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 Zentiva work?

Emtricitabine/Tenofovir disoproxil Zentiva 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.

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

How has Emtricitabine/Tenofovir disoproxil Zentiva been studied?

Studies on the benefits and risks of the active substances in the approved uses have already been carried out with the reference medicine, Truvada, and do not need to be repeated for Emtricitabine/Tenofovir disoproxil Zentiva.

As for every medicine, the company provided studies on the quality of Emtricitabine/Tenofovir disoproxil Zentiva. The company also carried out a study that showed that it 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 Emtricitabine/Tenofovir disoproxil Zentiva?

Because Emtricitabine/Tenofovir disoproxil Zentiva 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 Zentiva approved?

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

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

The company that markets Emtricitabine/Tenofovir disoproxil Zentiva will provide an information pack to doctors, which covers the risk of reduced kidney function with Emtricitabine/Tenofovir disoproxil Zentiva in adults and children.

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

Other information about Emtricitabine/Tenofovir disoproxil Zentiva

The European Commission granted a marketing authorisation valid throughout the European Union for Emtricitabine/Tenofovir disoproxil Zentiva on 9 November 2016.

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

The full EPAR for the reference medicine can also be found on the Agency’s website.

Name Language First published Last updated
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - Summary for the public BG = bălgarski 2016-11-23 2018-01-23
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - Summary for the public ES = español 2016-11-23 2018-01-23
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - Summary for the public CS = čeština 2016-11-23 2018-01-23
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - Summary for the public DA = dansk 2016-11-23 2018-01-23
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - Summary for the public DE = Deutsch 2016-11-23 2018-01-23
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - Summary for the public ET = eesti keel 2016-11-23 2018-01-23
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - Summary for the public EL = elliniká 2016-11-23 2018-01-23
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - Summary for the public EN = English 2016-11-23 2018-01-23
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - Summary for the public FR = français 2016-11-23 2018-01-23
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - Summary for the public IT = italiano 2016-11-23 2018-01-23
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - Summary for the public LV = latviešu valoda 2016-11-23 2018-01-23
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - Summary for the public LT = lietuvių kalba 2016-11-23 2018-01-23
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - Summary for the public HU = magyar 2016-11-23 2018-01-23
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - Summary for the public MT = Malti 2016-11-23 2018-01-23
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - Summary for the public NL = Nederlands 2016-11-23 2018-01-23
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - Summary for the public PL = polski 2016-11-23 2018-01-23
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - Summary for the public PT = português 2016-11-23 2018-01-23
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - Summary for the public RO = română 2016-11-23 2018-01-23
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - Summary for the public SK = slovenčina 2016-11-23 2018-01-23
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - Summary for the public SL = slovenščina 2016-11-23 2018-01-23
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - Summary for the public FI = suomi 2016-11-23 2018-01-23
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - Summary for the public SV = svenska 2016-11-23 2018-01-23
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - Summary for the public HR = Hrvatski 2016-11-23 2018-01-23

This EPAR was last updated on 23/01/2018 .

Authorisation details

Product details

Product details for Emtricitabine/Tenofovir disoproxil Zentiva
NameEmtricitabine/Tenofovir disoproxil Zentiva
Agency product numberEMEA/H/C/004137
Active substance

emtricitabine, tenofovir disoproxil phosphate

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 Zentiva
Marketing-authorisation holder

Zentiva k.s.

Revision1
Date of issue of marketing authorisation valid throughout the European Union09/11/2016

Contact address:

Zentiva k.s.
U kabelovny 130 
Dolni Mecholupy 102 37 
Prague 10 
Czech Republic

Product information

Product information

13/10/2017  Emtricitabine/Tenofovir disoproxil Zentiva -EMEA/H/C/004137 -IB/0002/G

Name Language First published Last updated
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - Product Information HR = Hrvatski 2016-11-23 2018-01-23
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - Product Information HR = Hrvatski 2016-11-23 2018-01-23
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - Product Information HR = Hrvatski 2016-11-23 2018-01-23
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - Product Information HR = Hrvatski 2016-11-23 2018-01-23
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - Product Information HR = Hrvatski 2016-11-23 2018-01-23
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - Product Information HR = Hrvatski 2016-11-23 2018-01-23
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - Product Information HR = Hrvatski 2016-11-23 2018-01-23
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - Product Information HR = Hrvatski 2016-11-23 2018-01-23
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - Product Information HR = Hrvatski 2016-11-23 2018-01-23
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - Product Information HR = Hrvatski 2016-11-23 2018-01-23
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - Product Information HR = Hrvatski 2016-11-23 2018-01-23
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - Product Information HR = Hrvatski 2016-11-23 2018-01-23
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - Product Information HR = Hrvatski 2016-11-23 2018-01-23
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - Product Information HR = Hrvatski 2016-11-23 2018-01-23
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - Product Information HR = Hrvatski 2016-11-23 2018-01-23
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - Product Information HR = Hrvatski 2016-11-23 2018-01-23
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - Product Information HR = Hrvatski 2016-11-23 2018-01-23
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - Product Information HR = Hrvatski 2016-11-23 2018-01-23
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - Product Information HR = Hrvatski 2016-11-23 2018-01-23
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - Product Information HR = Hrvatski 2016-11-23 2018-01-23
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - Product Information HR = Hrvatski 2016-11-23 2018-01-23
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - Product Information HR = Hrvatski 2016-11-23 2018-01-23
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - Product Information HR = Hrvatski 2016-11-23 2018-01-23
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - Product Information HR = Hrvatski 2016-11-23 2018-01-23
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - Product Information HR = Hrvatski 2016-11-23 2018-01-23

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 Zentiva : EPAR - All Authorised presentations HR = Hrvatski 2016-11-23  
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - All Authorised presentations HR = Hrvatski 2016-11-23  
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - All Authorised presentations HR = Hrvatski 2016-11-23  
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - All Authorised presentations HR = Hrvatski 2016-11-23  
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - All Authorised presentations HR = Hrvatski 2016-11-23  
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - All Authorised presentations HR = Hrvatski 2016-11-23  
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - All Authorised presentations HR = Hrvatski 2016-11-23  
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - All Authorised presentations HR = Hrvatski 2016-11-23  
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - All Authorised presentations HR = Hrvatski 2016-11-23  
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - All Authorised presentations HR = Hrvatski 2016-11-23  
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - All Authorised presentations HR = Hrvatski 2016-11-23  
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - All Authorised presentations HR = Hrvatski 2016-11-23  
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - All Authorised presentations HR = Hrvatski 2016-11-23  
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - All Authorised presentations HR = Hrvatski 2016-11-23  
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - All Authorised presentations HR = Hrvatski 2016-11-23  
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - All Authorised presentations HR = Hrvatski 2016-11-23  
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - All Authorised presentations HR = Hrvatski 2016-11-23  
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - All Authorised presentations HR = Hrvatski 2016-11-23  
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - All Authorised presentations HR = Hrvatski 2016-11-23  
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - All Authorised presentations HR = Hrvatski 2016-11-23  
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - All Authorised presentations HR = Hrvatski 2016-11-23  
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - All Authorised presentations HR = Hrvatski 2016-11-23  
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - All Authorised presentations HR = Hrvatski 2016-11-23  
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - All Authorised presentations HR = Hrvatski 2016-11-23  
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - All Authorised presentations HR = Hrvatski 2016-11-23  

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Emtricitabine/Tenofovir disoproxil Zentiva is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults (see section 5.1).

Emtricitabine/Tenofovir disoproxil Zentiva is also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, aged 12 to < 18 years (see section 5.1).

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Emtricitabine/Tenofovir disoproxil Zentiva : EPAR - Public assessment report HR = Hrvatski 2016-11-23  
CHMP summary of opinion for Emtricitabine/Tenofovir disoproxil Zentiva HR = Hrvatski 2016-09-16  

Authorised

This medicine is approved for use in the European Union

More information on Emtricitabine/Tenofovir disoproxil Zentiva