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

eisai australia pty ltd - lenvatinib mesilate, quantity: 12.25 mg (equivalent: lenvatinib, qty 10 mg) - capsule, hard - excipient ingredients: microcrystalline cellulose; iron oxide yellow; purified talc; iron oxide red; calcium carbonate; propylene glycol; hyprolose; mannitol; potassium hydroxide; titanium dioxide; hypromellose; iron oxide black; shellac - endometrial carcinoma lenvima, in combination with pembrolizumab, is indicated for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (msi-h) or mismatch repair deficient (dmmr), who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation., differentiated thyroid cancer (dtc) lenvima is indicated for the treatment of patients with progressive, locally advanced or metastatic, radioactive iodine (rai) refractory differentiated thyroid cancer (dtc).,renal cell carcinoma (rcc) lenvima, in combination with pembrolizumab, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (rcc).,lenvima, in combination with everolimus, is indicated for the treatment of adult patients with advanced renal cell carcinoma (rcc) whose disease has progressed following one prior vascular endothelial growth factor targeted therapy.,hepatocellular carcinoma (hcc) lenvima is indicated for the first-line treatment of patients with unresectable hepatocellular carcinoma (hcc).

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

eisai australia pty ltd - lenvatinib mesilate, quantity: 4.9 mg (equivalent: lenvatinib, qty 4 mg) - capsule, hard - excipient ingredients: iron oxide yellow; propylene glycol; potassium hydroxide; mannitol; iron oxide black; titanium dioxide; hypromellose; purified talc; iron oxide red; calcium carbonate; microcrystalline cellulose; hyprolose; shellac - endometrial carcinoma lenvima, in combination with pembrolizumab, is indicated for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (msi-h) or mismatch repair deficient (dmmr), who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.,differentiated thyroid cancer (dtc) lenvima is indicated for the treatment of patients with progressive, locally advanced or metastatic, radioactive iodine (rai) refractory differentiated thyroid cancer (dtc).,renal cell carcinoma (rcc) lenvima, in combination with pembrolizumab, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (rcc).,lenvima, in combination with everolimus, is indicated for the treatment of adult patients with advanced renal cell carcinoma (rcc) whose disease has progressed following one prior vascular endothelial growth factor targeted therapy.,hepatocellular carcinoma (hcc) lenvima is indicated for the first-line treatment of patients with unresectable hepatocellular carcinoma (hcc).

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

bayer australia ltd - larotrectinib sulfate, quantity: 30.7 mg - capsule, hard - excipient ingredients: gelatin; propylene glycol; dimethicone 12500; brilliant blue fcf aluminium lake; titanium dioxide; shellac; strong ammonia solution - vitrakvi (larotrectinib) has provisional approval in australia for the treatment of adult and paediatric patients with locally advanced or metastatic solid tumours that:,? have a neurotrophic tyrosine receptor kinase (ntrk) gene fusion without a known acquired resistance mutation, ? are metastatic or where surgical resection is likely to result in severe morbidity, and ? have either progressed following treatment or who have no satisfactory alternative therapy. the decision to approve this indication has been made on the basis of objective response rate (orr) and duration of response from single arm clinical studies. the sponsor is required to submit further clinical data to confirm the clinical benefit of the medicine.

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

bayer australia ltd - larotrectinib sulfate, quantity: 122.9 mg - capsule, hard - excipient ingredients: titanium dioxide; shellac; gelatin; dimethicone 12500; propylene glycol; brilliant blue fcf aluminium lake; strong ammonia solution - vitrakvi (larotrectinib) has provisional approval in australia for the treatment of adult and paediatric patients with locally advanced or metastatic solid tumours that:,? have a neurotrophic tyrosine receptor kinase (ntrk) gene fusion without a known acquired resistance mutation, ? are metastatic or where surgical resection is likely to result in severe morbidity, and ? have either progressed following treatment or who have no satisfactory alternative therapy. the decision to approve this indication has been made on the basis of objective response rate (orr) and duration of response from single arm clinical studies. the sponsor is required to submit further clinical data to confirm the clinical benefit of the medicine.

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

roche products pty ltd - pralsetinib, quantity: 100 mg - capsule, hard - excipient ingredients: sodium bicarbonate; microcrystalline cellulose; magnesium stearate; citric acid; pregelatinised starch; hypromellose; titanium dioxide; brilliant blue fcf; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; shellac; ethanol absolute; ammonia; potassium hydroxide - non-small cell lung cancer (nsclc),gavreto has provisional approval in australia for the treatment of adult patients with locally advanced or metastatic rearranged during transfection (ret) fusion-positive non-small cell lung cancer (nsclc). the decision to approve this indication has been made on the basis of overall response rate (orr) and duration of response (dor) in single-arm trials. continued approval of this indication depends on verification and description of benefit in confirmatory trials. ret-fusion positive thyroid cancer,gavreto has provisional approval in australia for the treatment of adult patients with advanced or metastatic ret-fusion positive thyroid cancer that is refractory to (or unsuitable for) radioactive iodine and who have progressed on or are unable to tolerate lenvatinib or sorafenib. the decision to approve this indication has been made on the basis of overall response rate (orr) and duration of response (dor). continued approval of this indication depends on verification and description of benefit in confirmatory trials.

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

seqirus pty ltd - avacopan, quantity: 10 mg - capsule, hard - excipient ingredients: shellac; iron oxide yellow; titanium dioxide; iron oxide red; gelatin; potassium hydroxide; iron oxide black; peg-40 hydrogenated castor oil; macrogol 4000; polysorbate 80 - tavneos, in combination with a rituximab or cyclophosphamide based regimen, is indicated for the treatment of adults with anti-neutrophil cytoplasmic autoantibody (anca)-associated vasculitis (granulomatosis with polyangiitis [gpa] and microscopic polyangiitis [mpa]).

Malta - English - Medicines Authority

boston biopharma limited malta life sciences park, building 2, level 0, san gwann sgn 3000, malta - imatinib mesilate - hard capsule - imatinib mesilate 100 mg - antineoplastic agents

Malta - English - Medicines Authority

boston biopharma limited malta life sciences park, building 2, level 0, san gwann sgn 3000, malta - imatinib mesilate - hard capsule - imatinib mesilate 200 mg - antineoplastic agents

Malta - English - Medicines Authority

boston biopharma limited malta life sciences park, building 2, level 0, san gwann sgn 3000, malta - imatinib - hard capsule - imatinib 400 mg - antineoplastic agents

Malta - English - Medicines Authority

fresenius kabi italia s.r.l via camagre 41, 37063 isola della scala (vr) , italy - lenalidomide - hard capsule - lenalidomide 2.5 mg - immunosuppressants