European Union - English - EMA (European Medicines Agency)

krka, d.d., novo mesto - emtricitabine, tenofovir disoproxil succinate - hiv infections - antivirals for systemic use - treatment of hiv-1 infectionemtricitabine/tenofovir disoproxil krka is indicated in antiretroviral combination therapy for the treatment of hiv-1 infected adults.emtricitabine/tenofovir disoproxil krka 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 (see section 5.1pre-exposure prophylaxis (prep)emtricitabine/tenofovir disoproxil krka is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired hiv-1 infection in adults at high risk.

European Union - English - EMA (European Medicines Agency)

krka, d.d., novo mesto - emtricitabine, tenofovir disoproxil succinate - hiv infections - antivirals for systemic use - 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.

Australia - English - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - emtricitabine, quantity: 200 mg; tenofovir disoproxil succinate, quantity: 300.6 mg - tablet, film coated - excipient ingredients: macrogol 3350; indigo carmine aluminium lake; magnesium stearate; isopropyl alcohol; polyvinyl alcohol; microcrystalline cellulose; titanium dioxide; lactose monohydrate; purified talc; croscarmellose sodium; purified water; pregelatinised maize starch - treatment of hiv-1 infection,tenofovir/emtricitabine sandoz is indicated for the treatment of hiv infected adults over the age of 18 years, in combination with other antiretroviral agents.,pre-exposure prophylaxis,tenofovir/emtricitabine sandoz is indicated in combination with safer sex practices for pre-exposure prophylaxis (prep) to reduce the risk of sexually acquired hiv-1 in adults at high risk. this indication is based on clinical trials in men who have sex with men (msm) at high risk for hiv-1 infection and in heterosexual serodiscordant couples (see section 5.1 pharmacodynamic properties, clinical trials).

European Union - English - EMA (European Medicines Agency)

krka, d.d., novo mesto - efavirenz, emtricitabine, tenofovir disoproxil succinate - hiv infections - antivirals for systemic use - efavirenz/emtricitabine/tenofovir disoproxil krka 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 krka 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.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.

Ireland - English - HPRA (Health Products Regulatory Authority)

clonmel healthcare ltd - emtricitabine; tenofovir disoproxil - film-coated tablet - 200 mg/245 milligram(s) - antivirals for treatment of hiv infections, combinations; tenofovir disoproxil and emtricitabine

New Zealand - English - Medsafe (Medicines Safety Authority)

teva pharma (new zealand) limited - tenofovir disoproxil succinate 300.6mg equivalent to tenofovir disoproxil 245 mg;   - film coated tablet - 245 mg - active: tenofovir disoproxil succinate 300.6mg equivalent to tenofovir disoproxil 245 mg   excipient: croscarmellose sodium indigo carmine aluminium lake lactose macrogol 3350 magnesium stearate microcrystalline cellulose polyvinyl alcohol pregelatinised maize starch purified talc purified water titanium dioxide - tenofovir disoproxil tablets in combination with other antiretroviral agents are indicated for the treatment of hiv-infected adults and paediatric patients 12 years of age and older.

Ireland - English - HPRA (Health Products Regulatory Authority)

clonmel healthcare ltd - efavirenz; emtricitabine; tenofovir disoproxil - film-coated tablet - 600 mg/200 mg/245 milligram(s) - antivirals for treatment of hiv infections, combinations; emtricitabine, tenofovir disoproxil and efavirenz

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

eg sa-nv - tenofovir disoproxil succinate 300,6 mg - eq. tenofovir disoproxil 245 mg; emtricitabine 200 mg - film-coated tablet - 200 mg - 245 mg - emtricitabine 200 mg; tenofovir disoproxil succinate 300.6 mg - tenofovir disoproxil and emtricitabine

Malta - English - Medicines Authority

pharos – pharmaceutical oriented services limited lesvou str. (end), thesi loggos, industrial zone, 144 52 metamorfossi attikis,, greece - efavirenz, emtricitabine, tenofovir disoproxil - film-coated tablet - efavirenz 600 mg emtricitabine 200 mg tenofovir disoproxil 245 mg - antivirals for systemic use

New Zealand - English - Medsafe (Medicines Safety Authority)

teva pharma (new zealand) limited - emtricitabine 200mg; tenofovir disoproxil succinate 300.6mg equivalent to tenofovir disoproxil 245mg;   - film coated tablet - active: emtricitabine 200mg tenofovir disoproxil succinate 300.6mg equivalent to tenofovir disoproxil 245mg   excipient: croscarmellose sodium indigo carmine aluminium lake lactose monohydrate macrogol 3350 magnesium stearate microcrystalline cellulose polyvinyl alcohol pregelatinised maize starch purified talc purified water titanium dioxide - indicated for the treatment of hiv infected adults over the age of 18 years, in combination with other antiretroviral agents.