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
**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
N/A
Pharmacotherapeutic Group
Antivirals for systemic use
Active Substance (Summary)
INN / Common Names
EMA Name
Emtricitabine/Tenofovir disoproxil Mylan
Medicine Name
Emtricitabine/Tenofovir disoproxil Mylan
Aliases
N/ANo risk management plan link.
