Australija - anglų - Department of Health (Therapeutic Goods Administration)

pharmacor pty ltd - imatinib mesilate, quantity: 478 mg (equivalent: imatinib, qty 400 mg) - tablet, film coated - excipient ingredients: magnesium stearate; titanium dioxide; macrogol 8000; hypromellose; purified talc - gilmat is indicated for the:,? treatment of patients with chronic myeloid leukaemia (cml) ? treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy ? treatment of adult patients with relapsed or refractory ph+ all as monotherapy ? treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements, where conventional therapies have failed ? treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) ?treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist) ?adjuvant treatment of adult patients at high risk of recurrence following complete gross resection of kit (cd117)-positive primary gist (see dosage and administration and clinical trials) ? treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).

Australija - anglų - Department of Health (Therapeutic Goods Administration)

pharmacor pty ltd - imatinib mesilate, quantity: 478 mg (equivalent: imatinib, qty 400 mg) - tablet, film coated - excipient ingredients: magnesium stearate; titanium dioxide; macrogol 8000; hypromellose; purified talc - gilmat is indicated for the:,? treatment of patients with chronic myeloid leukaemia (cml) ? treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy ? treatment of adult patients with relapsed or refractory ph+ all as monotherapy ? treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements, where conventional therapies have failed ? treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) ?treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist) ?adjuvant treatment of adult patients at high risk of recurrence following complete gross resection of kit (cd117)-positive primary gist (see dosage and administration and clinical trials) ? treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).

Australija - anglų - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - vericiguat, quantity: 5 mg - tablet, film coated - excipient ingredients: hypromellose; magnesium stearate; lactose monohydrate; microcrystalline cellulose; iron oxide red; sodium lauryl sulfate; purified talc; croscarmellose sodium; titanium dioxide - verquvo? is indicated in addition to standard of care therapy for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction less than 45[percent] who are stabilised after a recent heart failure decompensation event requiring admission and/or iv diuretic therapy (see section 5.1 pharmacodynamic properties ? clinical trials).

Australija - anglų - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - vericiguat, quantity: 2.5 mg - tablet, film coated - excipient ingredients: magnesium stearate; croscarmellose sodium; lactose monohydrate; titanium dioxide; microcrystalline cellulose; purified talc; hypromellose; sodium lauryl sulfate - verquvo? is indicated in addition to standard of care therapy for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction less than 45[percent] who are stabilised after a recent heart failure decompensation event requiring admission and/or iv diuretic therapy (see section 5.1 pharmacodynamic properties ? clinical trials).

Australija - anglų - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - vericiguat, quantity: 10 mg - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; hypromellose; purified talc; titanium dioxide; croscarmellose sodium; sodium lauryl sulfate; iron oxide yellow; magnesium stearate - verquvo? is indicated in addition to standard of care therapy for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction less than 45[percent] who are stabilised after a recent heart failure decompensation event requiring admission and/or iv diuretic therapy (see section 5.1 pharmacodynamic properties ? clinical trials).

Australija - anglų - Department of Health (Therapeutic Goods Administration)

lupin australia pty limited - emtricitabine, quantity: 200 mg; tenofovir disoproxil phosphate, quantity: 291 mg - tablet, film coated - excipient ingredients: mannitol; purified water; colloidal anhydrous silica; croscarmellose sodium; microcrystalline cellulose; stearic acid; titanium dioxide; lactose monohydrate; hypromellose; triacetin; indigo carmine aluminium lake - treatment of hiv-1 infection tenofovir emt gh 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 emt gh 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 clinical studies).

Australija - anglų - Department of Health (Therapeutic Goods Administration)

lupin australia pty limited - tenofovir disoproxil phosphate, quantity: 291 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; croscarmellose sodium; stearic acid; titanium dioxide; lactose monohydrate; hypromellose; triacetin; indigo carmine aluminium lake - tenofovir gh in combination with other antiretroviral agents is indicated for the treatment of hiv infected adults and paediatric patients 12 years of age and older. tenofovir gh is indicated for the treatment of chronic hepatitis b in adults (see clinical trials). tenofovir gh is indicated for the treatment of chronic hepatitis b in paediatric patients 12 years of age and older with compensated liver disease and with evidence of immune active disease, i.e. active viral replication, persistently elevated serum alt levels or evidence of active inflammation.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

cipla australia pty ltd - entecavir monohydrate, quantity: 0.532 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; crospovidone; hyprolose; magnesium stearate; lactose monohydrate; titanium dioxide; hypromellose; macrogol 6000 - entac is indicated for the treatment of chronic hepatitis b virus infection in adults 16 years or older with evidence of active liver inflammation.,this indication is based on histologic, virologic, biochemical and serological responses in nucleoside-treatment na?ve and lamivudine-resistant adult patients with hbeag-positive or hbeag-negative chronic hbv infection with compensated liver disease.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

cipla australia pty ltd - entecavir monohydrate, quantity: 1.064 mg - tablet, film coated - excipient ingredients: magnesium stearate; lactose monohydrate; microcrystalline cellulose; hyprolose; crospovidone; titanium dioxide; hypromellose; iron oxide red; macrogol 400 - entac is indicated for the treatment of chronic hepatitis b virus infection in adults 16 years or older with evidence of active liver inflammation.,this indication is based on histologic, virologic, biochemical and serological responses in nucleoside-treatment na?ve and lamivudine-resistant adult patients with hbeag-positive or hbeag-negative chronic hbv infection with compensated liver disease.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

sun pharma anz pty ltd - entecavir, quantity: 1 mg - tablet, film coated - excipient ingredients: lactose monohydrate; povidone; crospovidone; microcrystalline cellulose; magnesium stearate; titanium dioxide; hypromellose; polysorbate 80; macrogol 400; iron oxide red - entecavir monohydrate is indicated for the treatment of chronic hepatitis b virus infection in adults 16 years or older with evidence of active liver inflammation. this indication is based on histologic, virologic, biochemical and serological responses in nucleoside-treatment na?ve and lamividine-resistant adult patients with hbeag-positive or hbeag-negative chronic hbv infection with compensated liver disease.