Emtricitabine/Tenofovir disoproxil Mylan

Authorised

This medicine is authorised for use in the European Union

emtricitabine / tenofovir disoproxil

Overview

Emtricitabine/Tenofovir disoproxil Mylan is an HIV medicine that is used in combination with at least one other HIV 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 in adolescents with HIV who are resistant to first-line treatments or who cannot take them because of side effects.

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

Emtricitabine/Tenofovir disoproxil Mylan 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 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 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 about using Emtricitabine/Tenofovir disoproxil Mylan, see the package leaflet or contact your doctor or pharmacist.

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.

For the treatment of HIV-infection, Emtricitabine/Tenofovir disoproxil Mylan, taken in combination with
at least one other HIV 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 holds off 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
Mylan 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 Mylan been studied?

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

As for every medicine, the company provided studies on the quality of Emtricitabine/Tenofovir
disoproxil Mylan. 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 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 authorised in the EU?

The European Medicines Agency 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 Agency’s view was that, as for Truvada, the benefit of Emtricitabine/Tenofovir disoproxil Mylan outweighs the identified risk and it can be authorised 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 potential harmful effects of Emtricitabine/Tenofovir disoproxil Mylan on kidney function and information about use for pre-exposure prophylaxis. Healthcare professionals will also receive a brochure and reminder card to hand out to individuals receiving the medicine for preexposure prophylaxis.

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.

As for all medicines, data on the use of Emtricitabine/Tenofovir disoproxil Mylan are continuously
monitored. Side effects reported with Emtricitabine/Tenofovir disoproxil Mylan are carefully evaluated
and any necessary action taken to protect patients.

Other information about Emtricitabine/Tenofovir disoproxil Mylan

Emtricitabine/Tenofovir disoproxil Mylan received a marketing authorisation valid throughout the EU on 16 December 2016.

Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Summary for the public

Reference Number: EMA/693101/2016

Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Risk Management Plan

Product information

Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Product information

Latest procedure affecting product information: IB/0025

22/11/2023

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

Product information documents contain:

• summary of product characteristics (annex I);
• manufacturing authorisation holder responsible for batch release (annex IIA);
• conditions of the marketing authorisation (annex IIB);
• labelling (annex IIIA);
• package leaflet (annex IIIB).

Emtricitabine / Tenofovir disoproxil Mylan : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Emtricitabine/Tenofovir disoproxil Mylan
• Active substance:
  • emtricitabine
  • tenofovir disoproxil maleate
• International non-proprietary name (INN) or common name:
  • emtricitabine
  • tenofovir disoproxil
• Therapeutic area (MeSH):
  HIV Infections
• Anatomical therapeutic chemical (ATC) code:
  J05AR03

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Treatment of HIV-1 infection:

• Emtricitabine/Tenofovir disoproxil Mylan is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults (see section 5.1).
• Emtricitabine/Tenofovir disoproxil Mylan is also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, (see sections 4.2, 4.4 and 5.1).

Pre-exposure prophylaxis (PrEP):

• Emtricitabine/Tenofovir disoproxil Mylan is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents at high risk (see sections 4.2, 4.4 and 5.1).

Authorisation details

• EMA product number:
  EMEA/H/C/004050
• Generic:

  This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

• Marketing authorisation holder:
  Mylan Pharmaceuticals Limited

  Damastown Industrial Park; Mulhuddart; Dublin 15; Ireland

• Opinion adopted:
  13/10/2016
• Marketing authorisation issued:
  16/12/2016
• Revision:
  15

Assessment history

Changes since initial authorisation of medicine

Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Public assessment report

AdoptedReference Number: EMA/CHMP/636453/2016

CHMP summary of positive opinion for Emtricitabine/Tenofovir disoproxil Mylan

AdoptedReference Number: EMA/CHMP/659472/2016