Yeni Zelanda - İngilizce - Medsafe (Medicines Safety Authority)

gilead sciences (nz) - emtricitabine 200mg;  ;  ;  ; rilpivirine hydrochloride 27.5mg equivalent to rilpivirine free base 25 mg;  ; tenofovir disoproxil fumarate 300mg;  ;  ;   - film coated tablet - active: emtricitabine 200mg       rilpivirine hydrochloride 27.5mg equivalent to rilpivirine free base 25 mg   tenofovir disoproxil fumarate 300mg       excipient: croscarmellose sodium lactose monohydrate magnesium stearate microcrystalline cellulose opadry polysorbate 20 povidone pregelatinised maize starch purified water - eviplera is indicated for the treatment of hiv infection in treatment-na?ve adult patients with plasma hiv-1 rna less than or equal to 100,000 copies/ml at the start of therapy. eviplera is also indicated in certain virologically-suppressed (hiv-1 rna <50 copies/ml) adult patients on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen (see clinical trials). patients must not have a history of resistance to any of the components of eviplera (tenofovir df, emtricitabine or rilpivirine).

İrlanda - İngilizce - HPRA (Health Products Regulatory Authority)

teva b.v. - tenofovir disoproxil - film-coated tablet - 245 milligram(s) - nucleoside and nucleotide reverse transcriptase inhibitors; tenofovir disoproxil

İrlanda - İngilizce - HPRA (Health Products Regulatory Authority)

rowex ltd - tenofovir disoproxil - film-coated tablet - 245 milligram(s) - nucleoside and nucleotide reverse transcriptase inhibitors; tenofovir disoproxil

İrlanda - İngilizce - HPRA (Health Products Regulatory Authority)

accord healthcare ireland ltd. - tenofovir disoproxil - film-coated tablet - 245 milligram(s) - nucleoside and nucleotide reverse transcriptase inhibitors; tenofovir disoproxil

İrlanda - İngilizce - HPRA (Health Products Regulatory Authority)

accord healthcare ireland ltd. - tenofovir disoproxil fumarate - film-coated tablet - 245 milligram(s) - tenofovir disoproxil

Avrupa Birliği - İngilizce - EMA (European Medicines Agency)

gilead sciences ireland uc - tenofovir disoproxil fumarate - hepatitis b, chronic; hiv infections - antivirals for systemic use - hiv 1 infectionviread 123 mg film coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of hiv 1 infected paediatric patients, with nrti resistance or toxicities precluding the use of first line agents, aged 6 to < 12 years who weigh from 17 kg to less than 22 kg.the choice of viread 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 infectionviread 123 mg film coated tablets are indicated for the treatment of chronic hepatitis b in paediatric patients aged 6 to < 12 years who weigh from 17 kg to less than 22 kg, withcompensated liver disease and evidence of immune active disease, i.e. active viral replication and persistently elevated serum alt levels, or histological evidence of moderate to severe inflammation and/or fibrosis.  with respect to the decision to initiate treatment in paediatric patients, see sections 4.2, 4.4, 4.8 and 5.1.hiv 1 infectionviread 163 mg film coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of hiv 1 infected paediatric patients, with nrti resistance or toxicities precluding the use of first line agents, aged 6 to < 12 years who weigh from 22 kg to less than 28 kg.the choice of viread 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 infectionviread 163 mg film coated tablets are indicated for the treatment of chronic hepatitis b in paediatric patients aged 6 to < 12 years who weigh from 22 kg to less than 28 kg, with:compensated liver disease and evidence of immune active disease, i.e. active viral replication and persistently elevated serum alt levels, or histological evidence of moderate to severe inflammation and/or fibrosis.  with respect to the decision to initiate treatment in paediatric patients, see sections 4.2, 4.4, 4.8 and 5.1.hiv 1 infectionviread 204 mg film coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of hiv 1 infected paediatric patients, with nrti resistance or toxicities precluding the use of first line agents, aged 6 to < 12 years who weigh from 28 kg to less than 35 kg.the choice of viread 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 infectionviread 204 mg film coated tablets are indicated for the treatment of chronic hepatitis b in paediatric patients aged 6 to < 12 years who weigh from 28 kg to less than 35 kg, with:compensated liver disease and evidence of immune active disease, i.e. active viral replication and persistently elevated serum alt levels or histological evidence of moderate to severe inflammation and/or fibrosis.  with respect to the decision to initiate treatment in paediatric patients, see sections 4.2, 4.4, 4.8 and 5.1.hiv 1 infectionviread 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 viread 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 viread 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).viread 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 viread 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 infectionviread 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 (see section 5.1).evidence of lamivudine resistant hepatitis b virus (see sections 4.8 and 5.1).decompensated liver disease (see sections 4.4, 4.8 and 5.1).viread 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 and persistently elevated serum alt levels, or histological evidence of moderate to severe inflammation and/or fibrosis.  with respect to the decision to initiate treatment in paediatric patients, see sections 4.2, 4.4, 4.8 and 5.1.hiv 1 infectionviread 33 mg/g granules are indicated in combination with other antiretroviral medicinal products for the treatment of hiv 1 infected paediatric patients, with nrti resistance or toxicities precluding the use of first line agents, from 2 to < 6 years of age, and above 6 years of age for whom a solid dosage form is not appropriate.viread 33 mg/g granules are also indicated in combination with other antiretroviral medicinal products for the treatment of hiv 1 infected adults for whom a solid dosage form is not appropriate.in adults, the demonstration of the benefit of viread 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 viread 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).the choice of viread 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 infectionviread 33 mg/g granules are indicated for the treatment of chronic hepatitis b in adults for whom a solid dosage form is not appropriate 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 (see section 5.1).evidence of lamivudine resistant hepatitis b virus (see sections 4.8 and 5.1).decompensated liver disease (see sections 4.4, 4.8 and 5.1).viread 33 mg/g granules are also indicated for the treatment of chronic hepatitis b in paediatric patients2 to < 18 years of age for whom a solid dosage form is not appropriate with:compensated liver disease and evidence of immune active disease, i.e. active viral replication, and persistently elevated serum alt levels, or histological evidence of moderate to severe inflammation and/or fibrosis.  with respect to the decision to initiate treatment in paediatric patients, see sections 4.2, 4.4, 4.8 and 5.1.

İrlanda - İngilizce - 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

Avrupa Birliği - İngilizce - EMA (European Medicines Agency)

gilead sciences ireland uc - elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate - hiv infections - antivirals for treatment of hiv infections, combinations, antivirals for systemic use - treatment of human immunodeficiency virus 1 (hiv 1) infection in adults aged 18 years and over who are antiretroviral treatment-naïve or are infected with hiv 1 without known mutations associated with resistance to any of the three antiretroviral agents in stribild.

Avrupa Birliği - İngilizce - EMA (European Medicines Agency)

zentiva k.s. - tenofovir disoproxil phosphate - hiv infections - antivirals for systemic use - hiv‑1 infectiontenofovir disoproxil zentiva is 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 zentiva is also indicated for the treatment of hiv‑1 infected adolescents, with nrti (nucleotide reverse transcriptase inhibitor) resistance or toxicities precluding the use of first line agents, aged 12 to < 18 years.the choice of tenofovir disoproxil zentiva 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 zentiva is 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 (see section 5.1);evidence of lamivudine-resistant hepatitis b virus (see sections 4.8 and 5.1);decompensated liver disease (see sections 4.4, 4.8 and 5.1).tenofovir disoproxil zentiva is 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 (see sections 4.4, 4.8 and 5.1).

Avrupa Birliği - İngilizce - 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.