Emtricitabine/Tenofovir disoproxil Krka

emtricitabine / tenofovir disoproxil

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

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

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

Emtricitabine/Tenofovir disoproxil Krka 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 Krka is also used to help prevent sexually transmitted HIV-1 infection in adults who are at high risk of being infected (‘pre-exposure prophylaxis’). It should be used in combination with safer sex practices, such as use of condoms.

Emtricitabine/Tenofovir disoproxil Krka contains two active substances, emtricitabine and tenofovir disoproxil. It is a ‘generic medicine’. This means that 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 Krka used?

Emtricitabine/Tenofovir disoproxil Krka 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 Krka is available as tablets (200 mg emtricitabine and 245 mg tenofovir disoproxil). The recommended dose for treating or preventing HIV-1 infection 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 Krka work?

Emtricitabine/Tenofovir disoproxil Krka 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 Krka, 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 Krka 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.

For pre-exposure prophylaxis of HIV-1 infection, it is expected that Emtricitabine/Tenofovir disoproxil Krka in the blood will stop the virus from multiplying and spreading from the site of infection in case the individual is exposed to the virus.

How has Emtricitabine/Tenofovir disoproxil Krka 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 Krka. As for every medicine, the company provided studies on the quality of Emtricitabine/Tenofovir disoproxil Krka.

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 Krka?

Because Emtricitabine/Tenofovir disoproxil Krka 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 Krka approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Emtricitabine/Tenofovir disoproxil Krka 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 Krka be approved for use in the EU.

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

The company that markets Emtricitabine/Tenofovir disoproxil Krka will provide an information pack to doctors which covers the risk of kidney disease with Emtricitabine/Tenofovir disoproxil Krka and use in pre-exposure prophylaxis. Healthcare professionals will also receive a brochure and reminder card to hand out to individuals receiving the medicine for pre-exposure prophylaxis.

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

Other information about Emtricitabine/Tenofovir disoproxil Krka

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

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

Name Language First published Last updated
Emtricitabine / Tenofovir disoproxil Krka : EPAR - Summary for the public BG = bălgarski 2017-04-04 2017-05-23
Emtricitabine / Tenofovir disoproxil Krka : EPAR - Summary for the public ES = español 2017-04-04 2017-05-23
Emtricitabine / Tenofovir disoproxil Krka : EPAR - Summary for the public CS = čeština 2017-04-04 2017-05-23
Emtricitabine / Tenofovir disoproxil Krka : EPAR - Summary for the public DA = dansk 2017-04-04 2017-05-23
Emtricitabine / Tenofovir disoproxil Krka : EPAR - Summary for the public DE = Deutsch 2017-04-04 2017-05-23
Emtricitabine / Tenofovir disoproxil Krka : EPAR - Summary for the public ET = eesti keel 2017-04-04 2017-05-23
Emtricitabine / Tenofovir disoproxil Krka : EPAR - Summary for the public EL = elliniká 2017-04-04 2017-05-23
Emtricitabine / Tenofovir disoproxil Krka : EPAR - Summary for the public EN = English 2017-04-04 2017-05-23
Emtricitabine / Tenofovir disoproxil Krka : EPAR - Summary for the public FR = français 2017-04-04 2017-05-23
Emtricitabine / Tenofovir disoproxil Krka : EPAR - Summary for the public IT = italiano 2017-04-04 2017-05-23
Emtricitabine / Tenofovir disoproxil Krka : EPAR - Summary for the public LV = latviešu valoda 2017-04-04 2017-05-23
Emtricitabine / Tenofovir disoproxil Krka : EPAR - Summary for the public LT = lietuvių kalba 2017-04-04 2017-05-23
Emtricitabine / Tenofovir disoproxil Krka : EPAR - Summary for the public HU = magyar 2017-04-04 2017-05-23
Emtricitabine / Tenofovir disoproxil Krka : EPAR - Summary for the public MT = Malti 2017-04-04 2017-05-23
Emtricitabine / Tenofovir disoproxil Krka : EPAR - Summary for the public NL = Nederlands 2017-04-04 2017-05-23
Emtricitabine / Tenofovir disoproxil Krka : EPAR - Summary for the public PL = polski 2017-04-04 2017-05-23
Emtricitabine / Tenofovir disoproxil Krka : EPAR - Summary for the public PT = português 2017-04-04 2017-05-23
Emtricitabine / Tenofovir disoproxil Krka : EPAR - Summary for the public RO = română 2017-04-04 2017-05-23
Emtricitabine / Tenofovir disoproxil Krka : EPAR - Summary for the public SK = slovenčina 2017-04-04 2017-05-23
Emtricitabine / Tenofovir disoproxil Krka : EPAR - Summary for the public SL = slovenščina 2017-04-04 2017-05-23
Emtricitabine / Tenofovir disoproxil Krka : EPAR - Summary for the public FI = suomi 2017-04-04 2017-05-23
Emtricitabine / Tenofovir disoproxil Krka : EPAR - Summary for the public SV = svenska 2017-04-04 2017-05-23
Emtricitabine / Tenofovir disoproxil Krka : EPAR - Summary for the public HR = Hrvatski 2017-04-04 2017-05-23

This EPAR was last updated on 23/05/2017 .

Authorisation details

Product details

Product details for Emtricitabine/Tenofovir disoproxil Krka
NameEmtricitabine/Tenofovir disoproxil Krka
Agency product numberEMEA/H/C/004215
Active substance

emtricitabine / tenofovir disoproxil succinate

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 Krka
Marketing-authorisation holder

KRKA, d.d., Novo mesto

Revision1
Date of issue of marketing authorisation valid throughout the European Union09/12/2016

Contact address:

KRKA, d.d., Novo mesto
Smarjeska cesta 6
8501 Novo mesto
Slovenia

Product information

Product information

05/05/2017  Emtricitabine/Tenofovir disoproxil Krka -EMEA/H/C/004215 -IB/0002

Name Language First published Last updated
Emtricitabine / Tenofovir disoproxil Krka : EPAR - Product Information HR = Hrvatski 2017-04-04 2017-05-23
Emtricitabine / Tenofovir disoproxil Krka : EPAR - Product Information HR = Hrvatski 2017-04-04 2017-05-23
Emtricitabine / Tenofovir disoproxil Krka : EPAR - Product Information HR = Hrvatski 2017-04-04 2017-05-23
Emtricitabine / Tenofovir disoproxil Krka : EPAR - Product Information HR = Hrvatski 2017-04-04 2017-05-23
Emtricitabine / Tenofovir disoproxil Krka : EPAR - Product Information HR = Hrvatski 2017-04-04 2017-05-23
Emtricitabine / Tenofovir disoproxil Krka : EPAR - Product Information HR = Hrvatski 2017-04-04 2017-05-23
Emtricitabine / Tenofovir disoproxil Krka : EPAR - Product Information HR = Hrvatski 2017-04-04 2017-05-23
Emtricitabine / Tenofovir disoproxil Krka : EPAR - Product Information HR = Hrvatski 2017-04-04 2017-05-23
Emtricitabine / Tenofovir disoproxil Krka : EPAR - Product Information HR = Hrvatski 2017-04-04 2017-05-23
Emtricitabine / Tenofovir disoproxil Krka : EPAR - Product Information HR = Hrvatski 2017-04-04 2017-05-23
Emtricitabine / Tenofovir disoproxil Krka : EPAR - Product Information HR = Hrvatski 2017-04-04 2017-05-23
Emtricitabine / Tenofovir disoproxil Krka : EPAR - Product Information HR = Hrvatski 2017-04-04 2017-05-23
Emtricitabine / Tenofovir disoproxil Krka : EPAR - Product Information HR = Hrvatski 2017-04-04 2017-05-23
Emtricitabine / Tenofovir disoproxil Krka : EPAR - Product Information HR = Hrvatski 2017-04-04 2017-05-23
Emtricitabine / Tenofovir disoproxil Krka : EPAR - Product Information HR = Hrvatski 2017-04-04 2017-05-23
Emtricitabine / Tenofovir disoproxil Krka : EPAR - Product Information HR = Hrvatski 2017-04-04 2017-05-23
Emtricitabine / Tenofovir disoproxil Krka : EPAR - Product Information HR = Hrvatski 2017-04-04 2017-05-23
Emtricitabine / Tenofovir disoproxil Krka : EPAR - Product Information HR = Hrvatski 2017-04-04 2017-05-23
Emtricitabine / Tenofovir disoproxil Krka : EPAR - Product Information HR = Hrvatski 2017-04-04 2017-05-23
Emtricitabine / Tenofovir disoproxil Krka : EPAR - Product Information HR = Hrvatski 2017-04-04 2017-05-23
Emtricitabine / Tenofovir disoproxil Krka : EPAR - Product Information HR = Hrvatski 2017-04-04 2017-05-23
Emtricitabine / Tenofovir disoproxil Krka : EPAR - Product Information HR = Hrvatski 2017-04-04 2017-05-23
Emtricitabine / Tenofovir disoproxil Krka : EPAR - Product Information HR = Hrvatski 2017-04-04 2017-05-23
Emtricitabine / Tenofovir disoproxil Krka : EPAR - Product Information HR = Hrvatski 2017-04-04 2017-05-23
Emtricitabine / Tenofovir disoproxil Krka : EPAR - Product Information HR = Hrvatski 2017-04-04 2017-05-23

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 Krka : EPAR - All Authorised presentations HR = Hrvatski 2017-04-04  
Emtricitabine / Tenofovir disoproxil Krka : EPAR - All Authorised presentations HR = Hrvatski 2017-04-04  
Emtricitabine / Tenofovir disoproxil Krka : EPAR - All Authorised presentations HR = Hrvatski 2017-04-04  
Emtricitabine / Tenofovir disoproxil Krka : EPAR - All Authorised presentations HR = Hrvatski 2017-04-04  
Emtricitabine / Tenofovir disoproxil Krka : EPAR - All Authorised presentations HR = Hrvatski 2017-04-04  
Emtricitabine / Tenofovir disoproxil Krka : EPAR - All Authorised presentations HR = Hrvatski 2017-04-04  
Emtricitabine / Tenofovir disoproxil Krka : EPAR - All Authorised presentations HR = Hrvatski 2017-04-04  
Emtricitabine / Tenofovir disoproxil Krka : EPAR - All Authorised presentations HR = Hrvatski 2017-04-04  
Emtricitabine / Tenofovir disoproxil Krka : EPAR - All Authorised presentations HR = Hrvatski 2017-04-04  
Emtricitabine / Tenofovir disoproxil Krka : EPAR - All Authorised presentations HR = Hrvatski 2017-04-04  
Emtricitabine / Tenofovir disoproxil Krka : EPAR - All Authorised presentations HR = Hrvatski 2017-04-04  
Emtricitabine / Tenofovir disoproxil Krka : EPAR - All Authorised presentations HR = Hrvatski 2017-04-04  
Emtricitabine / Tenofovir disoproxil Krka : EPAR - All Authorised presentations HR = Hrvatski 2017-04-04  
Emtricitabine / Tenofovir disoproxil Krka : EPAR - All Authorised presentations HR = Hrvatski 2017-04-04  
Emtricitabine / Tenofovir disoproxil Krka : EPAR - All Authorised presentations HR = Hrvatski 2017-04-04  
Emtricitabine / Tenofovir disoproxil Krka : EPAR - All Authorised presentations HR = Hrvatski 2017-04-04  
Emtricitabine / Tenofovir disoproxil Krka : EPAR - All Authorised presentations HR = Hrvatski 2017-04-04  
Emtricitabine / Tenofovir disoproxil Krka : EPAR - All Authorised presentations HR = Hrvatski 2017-04-04  
Emtricitabine / Tenofovir disoproxil Krka : EPAR - All Authorised presentations HR = Hrvatski 2017-04-04  
Emtricitabine / Tenofovir disoproxil Krka : EPAR - All Authorised presentations HR = Hrvatski 2017-04-04  
Emtricitabine / Tenofovir disoproxil Krka : EPAR - All Authorised presentations HR = Hrvatski 2017-04-04  
Emtricitabine / Tenofovir disoproxil Krka : EPAR - All Authorised presentations HR = Hrvatski 2017-04-04  
Emtricitabine / Tenofovir disoproxil Krka : EPAR - All Authorised presentations HR = Hrvatski 2017-04-04  
Emtricitabine / Tenofovir disoproxil Krka : EPAR - All Authorised presentations HR = Hrvatski 2017-04-04  
Emtricitabine / Tenofovir disoproxil Krka : EPAR - All Authorised presentations HR = Hrvatski 2017-04-04  

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Emtricitabine/tenofovir disoproxil Krka is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Emtricitabine / Tenofovir disoproxil Krka : EPAR - Public assessment report HR = Hrvatski 2017-04-04  
CHMP summary of positive opinion for Emtricitabine/tenofovir disoproxil Krka HR = Hrvatski 2016-10-14  

Authorised

This medicine is approved for use in the European Union

More information on Emtricitabine/Tenofovir disoproxil Krka