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.
Therapeutic Indication
### 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).
Therapeutic Area (MeSH)
ATC Code
J05AR03
ATC Item
tenofovir disoproxil and emtricitabine
Pharmacotherapeutic Group
Antivirals for systemic use
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| emtricitabine | N/A | 恩曲他滨 |
| tenofovir disoproxil maleate | N/A | Tenofovir disoproxil hemiedisylate |
EMA Name
Emtricitabine/Tenofovir disoproxil Mylan
Medicine Name
Emtricitabine/Tenofovir disoproxil Mylan
Aliases
N/ANo risk management plan link.