Australië - Engels - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - emtricitabine,tenofovir disoproxil maleate -

Europese Unie - Engels - EMA (European Medicines Agency)

mylan pharmaceuticals limited - tenofovir disoproxil - hiv infections - antivirals for systemic use - hiv-1 infectiontenofovir disoproxil 245 mg film-coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of hiv-1 infected adults.in adults, the demonstration of the benefit of tenofovir disoproxil in hiv-1 infection is based on results of one study in treatment-naïve patients, including patients with a high viral load (> 100,000 copies/ml) and studies in which tenofovir disoproxil was added to stable background therapy (mainly tritherapy) in antiretroviral pre-treated patients experiencing early virological failure (< 10,000 copies/ml, with the majority of patients having < 5,000 copies/ml).tenofovir disoproxil 245 mg film-coated tablets are 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.the choice of tenofovir disoproxil to treat antiretroviral-experienced patients with hiv-1 infection should be based on individual viral resistance testing and/or treatment history of patients.hepatitis b infectiontenofovir disoproxil 245 mg film-coated tablets are indicated for the treatment of chronic hepatitis b in adults with:compensated liver disease, with evidence of active viral replication, persistently elevated serum alanine aminotransferase (alt) levels and histological evidence of active inflammation and/or fibrosis.evidence of lamivudine-resistant hepatitis b virus.decompensated liver disease.tenofovir disoproxil 245 mg film-coated tablets are indicated for the treatment of chronic hepatitis b in adolescents 12 to < 18 years of age with:compensated liver disease and evidence of immune active disease, i.e. active viral replication, persistently elevated serum alt levels and histological evidence of active inflammation and/or fibrosis.

Nieuw-Zeeland - Engels - Medsafe (Medicines Safety Authority)

viatris limited - emtricitabine 200mg;  ; tenofovir disoproxil maleate 300mg equivalent to tenofovir disoproxil 245 mg; emtricitabine 200mg; tenofovir disoproxil maleate 300mg equivalent to tenofovir disoproxil 245 mg - film coated tablet - 200 mg/300 mg - active: emtricitabine 200mg   tenofovir disoproxil maleate 300mg equivalent to tenofovir disoproxil 245 mg excipient: colloidal silicon dioxide hyprolose iron oxide red lactose monohydrate magnesium stearate microcrystalline cellulose opadry green 31k510010 active: emtricitabine 200mg tenofovir disoproxil maleate 300mg equivalent to tenofovir disoproxil 245 mg excipient: colloidal silicon dioxide hyprolose iron oxide red lactose monohydrate magnesium stearate microcrystalline cellulose opadry green 32k510087 - treatment of hiv-1 infection tenofovir disoproxil emtricitabine viatris is indicated for the treatment of hiv infected adults over the age of 18 years, in combination with other antiretroviral agents.

Ierland - Engels - HPRA (Health Products Regulatory Authority)

tillomed pharma gmbh - emtricitabine; tenofovir disoproxil fumarate - film-coated tablet - 200/245 milligram(s) - antivirals for treatment of hiv infections, combinations; tenofovir disoproxil and emtricitabine

Ierland - Engels - HPRA (Health Products Regulatory Authority)

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

Ierland - Engels - 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

Ierland - Engels - HPRA (Health Products Regulatory Authority)

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

Ierland - Engels - HPRA (Health Products Regulatory Authority)

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

Australië - Engels - 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).

Verenigd Koninkrijk - Engels - MHRA (Medicines & Healthcare Products Regulatory Agency)

lupin healthcare (uk - tenofovir disoproxil - tablet - 245mg