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 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 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 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.
- How has Emtricitabine/Tenofovir disoproxil Krka been studied?
Because Emtricitabine/Tenofovir disoproxil Krka 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 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.
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.
This EPAR was last updated on 04/04/2017 .
09/12/2016 Emtricitabine / Tenofovir disoproxil Krka -EMEA/H/C/004215 --
- 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
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Antivirals for systemic use
Emtricitabine/tenofovir disoproxil Krka is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults.
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 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|
This medicine is approved for use in the European Union
More information on Emtricitabine/Tenofovir disoproxil Krka
- Questions and answers on generic medicines (2012-12-07)