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

novartis pharmaceuticals australia pty ltd - imatinib, quantity: 400 mg (equivalent: imatinib mesilate, qty 478 mg) - tablet, film coated - excipient ingredients: colloidal anhydrous silica; crospovidone; microcrystalline cellulose; hypromellose; magnesium stearate; purified talc; iron oxide red; macrogol 4000; iron oxide yellow - glivec 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 aggressive systemic mastocytosis (asm) 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)

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

novartis pharmaceuticals australia pty ltd - imatinib, quantity: 100 mg (equivalent: imatinib mesilate, qty 119.5 mg) - tablet, film coated - excipient ingredients: crospovidone; hypromellose; colloidal anhydrous silica; magnesium stearate; microcrystalline cellulose; purified talc; iron oxide yellow; macrogol 4000; iron oxide red - glivec 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 aggressive systemic mastocytosis (asm) 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) glivec is indicated for the: -treatment of patients with chronic myeloid leukaemia (cml). -treatment of adult 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 aggressive systemic mastocytosis (asm) 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).

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

viiv healthcare pty ltd - rilpivirine hydrochloride, quantity: 27.5 mg (equivalent: rilpivirine, qty 25 mg); dolutegravir, quantity: 50 mg - tablet, film coated - excipient ingredients: macrogol 3350; silicified microcrystalline cellulose; povidone; sodium starch glycollate type a; polyvinyl alcohol; microcrystalline cellulose; magnesium stearate; lactose monohydrate; iron oxide yellow; croscarmellose sodium; iron oxide red; mannitol; purified talc; titanium dioxide; sodium stearylfumarate; polysorbate 20 - juluca (dolutegravir/rilpivirine) is indicated for the treatment of human immunodeficiency virus-1 (hiv-1) infection in adults who are virologically-suppressed (hiv-1 rna less than 50 copies per ml) on a stable antiretroviral regimen for at least 6 months with no history of virological failure and no known or suspected resistance to any non-nucleoside reverse transcriptase inhibitor or integrase inhibitor (see section 5.1 pharmacodynamic properties, clinical trials).

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

pharmacor pty ltd - imatinib mesilate, quantity: 119.5 mg (equivalent: imatinib, qty 100 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).

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

alphapharm pty ltd - lamivudine, quantity: 300 mg; abacavir sulfate, quantity: 702.78 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; colloidal anhydrous silica; magnesium stearate; silicified microcrystalline cellulose; purified talc; crospovidone; titanium dioxide; hypromellose; polysorbate 80; macrogol 400 - abacavir/lamivudine viatris tablets are a combination of two nucleoside analogues (abacavir and lamivudine). abacavir/lamivudine viatris is indicated in antiretroviral combination therapy for the treatment of human immunodeficiency virus (hiv) infection in adults and adolescents from 12 years of age.

Australia - English - 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).

Australia - English - 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).

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

pharmacor pty ltd - imatinib mesilate, quantity: 119.5 mg (equivalent: imatinib, qty 100 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).

Israel - English - Ministry of Health

j-c health care ltd - emtricitabine; rilpivirine as hydrochloride; tenofovir alafenamide as fumarate - film coated tablets - tenofovir alafenamide as fumarate 25 mg; emtricitabine 200 mg; rilpivirine as hydrochloride 25 mg - rilpivirine - odefsey is indicated for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus 1 (hiv 1) without known mutations associated with resistance to the non nucleoside reverse transcriptase inhibitor (nnrti) class, tenofovir or emtricitabine and with a viral load ≤ 100,000 hiv 1 rna copies/ml

Israel - English - Ministry of Health

j-c health care ltd - emtricitabine; rilpivirine as hydrochloride; tenofovir alafenamide as fumarate - film coated tablets - tenofovir alafenamide as fumarate 25 mg; emtricitabine 200 mg; rilpivirine as hydrochloride 25 mg - rilpivirine - odefsey is indicated for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus 1 (hiv 1) without known mutations associated with resistance to the non nucleoside reverse transcriptase inhibitor (nnrti) class, tenofovir or emtricitabine and with a viral load ≤ 100,000 hiv 1 rna copies/ml