South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

austell pharmaceuticals (pty) ltd - capsules - 50,0 mg - each capsule contains etifoxine hydrochloride

Australia - English - 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).

Australia - English - 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).

Australia - English - 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).

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

janssen-cilag pty ltd - tenofovir alafenamide, quantity: 10 mg; darunavir, quantity: 800 mg; cobicistat, quantity: 150 mg; emtricitabine, quantity: 200 mg - tablet, film coated - excipient ingredients: magnesium stearate; croscarmellose sodium; silicon dioxide; microcrystalline cellulose; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - symtuza is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in adults and adolescents (aged 12 years and older with body weight at least 40 kg). genotypic testing should guide the use of symtuza (see section 4.2 dose and method of administration, section 4.4 special warnings and precautions for use and section 5.1 pharmacodynamic properties).

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)

seqirus pty ltd - safinamide mesilate, quantity: 65.88 mg (equivalent: safinamide, qty 50 mg) - tablet, film coated - excipient ingredients: crospovidone; magnesium stearate; colloidal anhydrous silica; microcrystalline cellulose; colour; hypromellose; macrogol 6000 - xadago is indicated for the treatment of adult patients with fluctuating idiopathic parkinson?s disease (pd) as add-on therapy to a regimen that includes levodopa (l-dopa)

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

seqirus pty ltd - safinamide mesilate, quantity: 131.76 mg (equivalent: safinamide, qty 100 mg) - tablet, film coated - excipient ingredients: colloidal anhydrous silica; magnesium stearate; microcrystalline cellulose; crospovidone; colour; hypromellose; macrogol 6000 - xadago is indicated for the treatment of adult patients with fluctuating idiopathic parkinson?s disease (pd) as add-on therapy to a regimen that includes levodopa (l-dopa)

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

sandoz pty ltd - olanzapine, quantity: 7.5 mg - tablet, film coated - excipient ingredients: crospovidone; lactose monohydrate; hyprolose; magnesium stearate; microcrystalline cellulose; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350 - treatment of schizophrenia and related psychoses. short-term treatment, alone or in combination with lithium or valproate, of acute manic episodes associated with bipolar i disorder. preventing recurrence of manic, mixed or depressive episodes in bipolar i disorder.