Basic Information
Emtricitabine/Tenofovir disoproxil Krka d.d.
Regulatory Information
EMEA/H/C/004686
April 28, 2017
February 23, 2017
13
July 12, 2024
Company Information
Slovenia
Smarjeska cesta 6 8501 Novo mesto
KRKA, d.d., Novo mesto
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Emtricitabine/Tenofovir disoproxil Krka d.d. is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults. Emtricitabine/Tenofovir disoproxil Krka d.d. is 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.
Overview Summary
Emtricitabine/Tenofovir disoproxil Krka d.d. 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 who are resistant to first-line treatments or who cannot take them because of side effects. Emtricitabine/Tenofovir disoproxil Krka d.d 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.