Overview

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

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

Tenofovir disoproxil Mylan is used to treat adults and adolescents from 12 years of age infected with human immunodeficiency virus type 1 (HIV 1), a virus that causes acquired immune deficiency syndrome (AIDS). Tenofovir disoproxil Mylan is used in combination with other HIV medicines. In adolescents (from 12 to 18 years of age) its use is only for those who cannot be treated with other first-line nucleotide reverse transcriptase inhibitors (NRTI). For patients who have taken medicines to treat HIV infection before, doctors should only prescribe Tenofovir disoproxil Mylan once they have looked at the antiviral medicines the patient has taken before or the likelihood of the virus’s response to antiviral medicines.

Tenofovir disoproxil Mylan is also used to treat chronic (long-term) hepatitis B virus infection in adults and adolescents from 12 years of age. It is used in patients with liver damage but whose liver is still working properly (compensated liver disease). In adults, it can also be used for those patients with liver damage whose liver is not working properly (decompensated liver disease) and those patients who do not respond to treatment with lamivudine (another medicine for hepatitis B).

Tenofovir disoproxil Mylan contains the active substance 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 Viread.

Tenofovir disoproxil Mylan can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of HIV infection or chronic hepatitis B.

Tenofovir disoproxil Mylan is available as tablets (245 mg) to be taken by mouth. The usual dose is one tablet taken once a day with food. The dose may need to be reduced or the medicine given less often in patients who have moderately or severely reduced kidney function. For more information, see the package leaflet.

The active substance in this medicine, tenofovir disoproxil, is a ‘prodrug’ that is converted into tenofovir in the body.

Tenofovir is a nucleotide reverse-transcriptase inhibitor (NRTI). In HIV infection, it blocks the activity of reverse transcriptase, an enzyme produced by HIV that allows it to reproduce itself in the cells it has infected. Tenofovir disoproxil Mylan, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level. Tenofovir disoproxil Mylan 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.

Tenofovir also interferes with the action of an enzyme produced by the hepatitis-B virus called ‘DNA polymerase’, which is involved in the formation of viral DNA. Tenofovir disoproxil Mylan stops the virus making DNA and prevents it from multiplying and spreading.

Because Tenofovir disoproxil Mylan is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Viread. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

Because 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.

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Tenofovir disoproxil Mylan has been shown to have comparable quality and to be bioequivalent to Viread. Therefore, the CHMP’s view was that, as for Viread, the benefit outweighs the identified risk. The Committee recommended that Tenofovir disoproxil Mylan be approved for use in the EU.

The company that makes Tenofovir disoproxil Mylan will also ensure that all doctors who are expected to prescribe or use the medicine are provided with educational materials containing important safety information, particularly on the risks and precautions relating to kidney function and the bones.

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

The European Commission granted a marketing authorisation valid throughout the European Union for Tenofovir disoproxil Mylan on 8 December 2016.

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

Tenofovir disoproxil Mylan : EPAR - Summary for the public

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Tenofovir disoproxil Mylan : EPAR - Risk management plan summary

Product information

Tenofovir disoproxil Mylan : EPAR - Product information

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Latest procedure affecting product information: IB/0027

06/06/2023

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This medicine’s product information is available in all official EU languages.
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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).

Tenofovir disoproxil Mylan : EPAR - All Authorised presentations

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Product details

Name of medicine
Tenofovir disoproxil Mylan
Active substance
tenofovir disoproxil
International non-proprietary name (INN) or common name
tenofovir disoproxil
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AF07

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

HIV-1 infection

Tenofovir disoproxil 245 mg film-coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults.

In adults, the demonstration of the benefit of tenofovir disoproxil in HIV-1 infection is based on results of one study in treatment-naïve patients, including patients with a high viral load (> 100,000 copies/ml) and studies in which tenofovir disoproxil was added to stable background therapy (mainly tritherapy) in antiretroviral pre-treated patients experiencing early virological failure (< 10,000 copies/ml, with the majority of patients having < 5,000 copies/ml).

Tenofovir disoproxil 245 mg film-coated tablets are 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.

The choice of tenofovir disoproxil to treat antiretroviral-experienced patients with HIV-1 infection should be based on individual viral resistance testing and/or treatment history of patients.

Hepatitis B infection

Tenofovir disoproxil 245 mg film-coated tablets are indicated for the treatment of chronic hepatitis B in adults with:

  • compensated liver disease, with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis.
  • evidence of lamivudine-resistant hepatitis B virus.
  • decompensated liver disease.

Tenofovir disoproxil 245 mg film-coated tablets are indicated for the treatment of chronic hepatitis B in adolescents 12 to < 18 years of age with:

  • compensated liver disease and evidence of immune active disease, i.e. active viral replication, persistently elevated serum ALT levels and histological evidence of active inflammation and/or fibrosis.

Authorisation details

EMA product number
EMEA/H/C/004049

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
08/12/2016
Revision
18

Assessment history

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

Tenofovir disoproxil Mylan-H-C-PSUSA-00002892-201903 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Tenofovir disoproxil Mylan : EPAR - Public assessment report

CHMP summary of positive opinion for Tenofovir disoproxil Mylan

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