Emtricitabine/Tenofovir disoproxil Mylan
emtricitabine / tenofovir disoproxil
Table of contents
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.
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Emtricitabine / Tenofovir disoproxil Mylan : EPAR - Summary for the public (PDF/122.44 KB)
First published: 03/02/2017
Last updated: 12/07/2019
EMA/693101/2016 -
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Emtricitabine/Tenofovir disoproxil Mylan : EPAR - Risk-management-plan summary (PDF/150.56 KB)
First published: 27/07/2023
Authorisation details
| Product details | |
|---|---|
| Name |
Emtricitabine/Tenofovir disoproxil Mylan
|
| Agency product number |
EMEA/H/C/004050
|
| Active substance |
|
| International non-proprietary name (INN) or common name |
|
| Therapeutic area (MeSH) |
HIV Infections
|
| Anatomical therapeutic chemical (ATC) code |
J05AR03
|
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. |
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Mylan Pharmaceuticals Limited
|
| Revision |
14
|
| Date of issue of marketing authorisation valid throughout the European Union |
16/12/2016
|
| Contact address |
Mylan Pharmaceuticals Limited |
Product information
05/07/2023 Emtricitabine/Tenofovir disoproxil Mylan - EMEA/H/C/004050 - IB/0024/G
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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).