Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan
Authorised
This medicine is authorised for use in the European Union
efavirenz / emtricitabine / tenofovir disoproxil
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
This is a summary of the European public assessment report (EPAR) for Efavirenz/Emtricitabine/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 the medicine.
For practical information about using Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan is an antiviral medicine used to treat adults infected with human immunodeficiency virus-1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
It is only used in patients who have responded well to their current HIV treatment and who do not have an HIV infection that is resistant to treatment or not likely to respond to any of the active substances in the medicine.
The medicine contains the active substances efavirenz, emtricitabine and tenofovir disoproxil and 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 Atripla.
This medicine is available as tablets and can only be obtained with a prescription. Treatment should be started by a doctor who has experience in the management of HIV infection. The recommended dose is one tablet daily, swallowed whole with water. It is recommended that the medicine be taken on an empty stomach, preferably at bedtime. Patients should take the medicine regularly and avoid missing doses.
If patients need to stop taking one of the active substances in the medicine, or need to take different doses, they will need to change to separate individual medicines. This medicine should not be taken at the same time as other medicines that contain efavirenz, emtricitabine or tenofovir disoproxil, or lamivudine (another antiviral medicine). For more information, see the package leaflet.
This medicine contains three active substances: efavirenz, which is a non-nucleoside reverse transcriptase inhibitor (NNRTI); emtricitabine, which is a nucleoside reverse transcriptase inhibitor; and tenofovir disoproxil, which is a ‘prodrug’ of tenofovir, meaning that it is converted into the active substance tenofovir in the body. Tenofovir is a nucleotide reverse transcriptase inhibitor. Both nucleoside and nucleotide reverse transcriptase inhibitors are commonly known as NRTIs. All three active substances block the activity of reverse transcriptase, an enzyme that allows HIV to reproduce itself in the cells it has infected.
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan keeps the amount of HIV in the blood at a low level. It 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.
Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Atripla, and do not need to be repeated for Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan.
As for every medicine, the company provided studies on its quality. The company also carried out a study that showed that the medicine 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.
Because Efavirenz/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.
The European Medicines Agency concluded that, in accordance with EU requirements, the medicine has been shown to have comparable quality and to be bioequivalent to Atripla. Therefore, the Agency’s view was that, as for Atripla, the benefit outweighs the identified risk. The Agency recommended that it be approved for use in the EU.
The company that markets the medicine will ensure that all doctors expected to prescribe the medicine are provided with an educational pack that includes information on the increased risk of kidney disease with medicines containing tenofovir disoproxil such as this one. The educational pack also contains recommendations for monitoring kidney function in patients taking the medicine.
Recommendations and precautions to be followed by healthcare professionals and patients for its safe and effective use 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 Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan on 5 September 2017.
For more information about treatment with this medicine, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Product information
Latest procedure affecting product information:
VR/0000179367
05/09/2024
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).
Product details
- Name of medicine
- Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan
- Active substance
- efavirenz
- emtricitabine
- tenofovir disoproxil maleate
- International non-proprietary name (INN) or common name
- efavirenz
- emtricitabine
- tenofovir disoproxil
- Therapeutic area (MeSH)
- HIV Infections
- Anatomical therapeutic chemical (ATC) code
- J05AR06
Pharmacotherapeutic group
Antivirals for systemic useTherapeutic indication
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan is a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil. It is indicated for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years and over with virologic suppression to HIV-1 RNA levels of < 50 copies/ml on their current combination antiretroviral therapy for more than three months. Patients must not have experienced virological failure on any prior antiretroviral therapy and must be known not to have harboured virus strains with mutations conferring significant resistance to any of the three components contained in Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan prior to initiation of their first antiretroviral treatment regimen.
The demonstration of the benefit of efavirenz/emtricitabine/tenofovir disoproxil is primarily based on 48-week data from a clinical study in which patients with stable virologic suppression on a combination antiretroviral therapy changed to efavirenz/emtricitabine/tenofovir disoproxil (see section 5.1). No data are currently available from clinical studies with efavirenz/emtricitabine/tenofovir disoproxil in treatment-naïve or in heavily pretreated patients.
No data are available to support the combination of efavirenz/emtricitabine/tenofovir disoproxil and other antiretroviral agents.
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