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

teva pharma australia pty ltd - everolimus, quantity: 7.5 mg - tablet - excipient ingredients: butylated hydroxytoluene; hypromellose; lactose monohydrate; lactose; crospovidone; magnesium stearate - the treatment of: - postmenopausal women with hormone receptor-positive, her2 negative advanced breast cancer in combination with exemestane after failure of treatment with letrozole and anastrozole - progressive, unresectable or metastatic, well or moderately differentiated neuroendocrine tumours (nets) of pancreatic origin - advanced renal cell carcinoma after failure of treatment with sorafenib or sunitinib - subependymal giant cell astrocytoma (sega) associated with tuberous sclerosis complex (tsc) who require therapeutic intervention but are not candidates for curative surgical resection - patients with tuberous sclerosis complex (tsc) who have renal angiomyolipoma not requiring immediate surgery.

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

teva pharma australia pty ltd - everolimus, quantity: 5 mg - tablet - excipient ingredients: butylated hydroxytoluene; hypromellose; lactose monohydrate; lactose; crospovidone; magnesium stearate - the treatment of: - postmenopausal women with hormone receptor-positive, her2 negative advanced breast cancer in combination with exemestane after failure of treatment with letrozole and anastrozole - progressive, unresectable or metastatic, well or moderately differentiated neuroendocrine tumours (nets) of pancreatic origin - advanced renal cell carcinoma after failure of treatment with sorafenib or sunitinib - subependymal giant cell astrocytoma (sega) associated with tuberous sclerosis complex (tsc) who require therapeutic intervention but are not candidates for curative surgical resection - patients with tuberous sclerosis complex (tsc) who have renal angiomyolipoma not requiring immediate surgery.

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

teva pharma australia pty ltd - everolimus, quantity: 2.5 mg - tablet - excipient ingredients: butylated hydroxytoluene; hypromellose; lactose monohydrate; lactose; crospovidone; magnesium stearate - the treatment of: - postmenopausal women with hormone receptor-positive, her2 negative advanced breast cancer in combination with exemestane after failure of treatment with letrozole and anastrozole - progressive, unresectable or metastatic, well or moderately differentiated neuroendocrine tumours (nets) of pancreatic origin - advanced renal cell carcinoma after failure of treatment with sorafenib or sunitinib - subependymal giant cell astrocytoma (sega) associated with tuberous sclerosis complex (tsc) who require therapeutic intervention but are not candidates for curative surgical resection - patients with tuberous sclerosis complex (tsc) who have renal angiomyolipoma not requiring immediate surgery.

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

roche products pty ltd - atezolizumab, quantity: 1200 mg - injection, concentrated - excipient ingredients: histidine; sucrose; water for injections; polysorbate 20; glacial acetic acid - early-stage non-small cell lung cancer,tecentriq as monotherapy is indicated as adjuvant treatment following complete resection and no progression after platinum-based adjuvant chemotherapy for adult patients with stage ii to iiia (as per 7th edition of the uicc/ajcc staging system) nsclc whose tumours have pd-l1 expression on greater than or equal to 50% of tumour cells.,metastatic non-small cell lung cancer,tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous non-small cell lung cancer (nsclc). in patients with egfr mutant or alk-positive nsclc, tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies.,tecentriq, in combination with nanoparticle albumin-bound paclitaxel (nab-paclitaxel) and carboplatin, is indicated for first-line treatment of patients with metastatic non-squamous nsclc who do not have tumour egfr or alk genomic aberrations.,tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic nsclc after prior chemotherapy. patients with egfr mutant or alk-positive nsclc should also have received targeted therapies before receiving tecentriq.,small cell lung cancer,tecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of patients with extensive-stage small cell lung cancer (es-sclc).,urothelial carcinoma,tecentriq is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who,? are considered cisplatin ineligible and whose tumours express pd-l1 (pd-l1 stained tumour-infiltrating immune cells [ic] covering greater than or equal to 5% of the tumour area), as determined by a validated test, or,? are considered ineligible for any other platinum-containing chemotherapy regardless of the level of tumour pd-l1 expression.,this indication is approved based on overall response rate and duration of response in a single-arm study. improvements in overall survival, progression-free survival, or health-related quality of life have not been established.,hepatocellular carcinoma,tecentriq, in combination with bevacizumab, is indicated for the treatment of patients with unresectable or metastatic hepatocellular carcinoma (hcc) who have not received prior systemic therapy.

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)

bristol-myers squibb australia pty ltd - nivolumab, quantity: 107 mg - injection, concentrated - excipient ingredients: sodium citrate dihydrate; pentetic acid; mannitol; sodium chloride; polysorbate 80; sodium hydroxide; water for injections; hydrochloric acid - melanoma,opdivo, as monotherapy, is indicated for the adjuvant treatment of adults and adolescent patients 12 years and older with completely resected stage iib, iic, iii or iv melanoma.,opdivo, as monotherapy, is indicated for the treatment of patients with unresectable or metastatic melanoma.,opdivo, in combination with ipilimumab, is indicated for the treatment of patients with unresectable or metastatic melanoma. the approval of this indication is based on a pre-specified comparison to ipilimumab monotherapy. all analyses comparing nivolumab monotherapy with the nivolumab/ipilimumab combination are descriptive.,non-small cell lung cancer (nsclc),opdivo, in combination with platinum-doublet chemotherapy, is indicated for the neoadjuvant treatment of patients with resectable non-small cell lung cancer (nsclc).,opdivo, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer (nsclc) with no egfr or alk genomic tumour aberrations.,opdivo, as monotherapy, is indicated for the treatment of locally advanced or metastatic squamous non-small cell lung cancer (nsclc) with progression on or after prior chemotherapy.,opdivo, as monotherapy, is indicated for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (nsclc) with progression on or after prior chemotherapy. in patients with tumour egfr or alk genomic aberrations, opdivo should be used after progression on or after targeted therapy.,malignant pleural mesothelioma (mpm),opdivo, in combination with ipilimumab, is indicated for the first-line treatment of patients with unresectable malignant pleural mesothelioma.,renal cell carcinoma (rcc),opdivo, in combination with ipilimumab, is indicated for the treatment of patients with intermediate/poor-risk, previously untreated advanced renal cell carcinoma.,opdivo, in combination with cabozantinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma.,opdivo, as monotherapy, is indicated for the treatment of patients with advanced clear cell renal cell carcinoma after prior anti-angiogenic therapy.,classical hodgkin lymphoma (chl),opdivo, as monotherapy, is indicated for the treatment of patients with relapsed or refractory classical hodgkin lymphoma (chl) after autologous stem cell transplant and treatment with brentuximab vedotin. the approval of this indication is based on objective response rate in a single arm study.,squamous cell carcinoma of the head and neck (scchn),opdivo, as monotherapy, is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in patients progressing on or after platinum based therapy.,urothelial carcinoma (uc),opdivo, as monotherapy, is indicated for the adjuvant treatment of patients with muscle invasive urothelial carcinoma (miuc) who are at high risk of recurrence after undergoing radical resection of miuc.,opdivo, as monotherapy, is indicated for the treatment of patients with locally advanced unresectable or metastatic urothelial carcinoma after prior platinum-containing therapy. the approval of this indication is based on objective response rate and duration of response in a single arm study.,hepatocellular carcinoma (hcc),opdivo, as monotherapy, is indicated for the treatment of patients with hepatocellular carcinoma after prior sorafenib therapy. this indication is approved based on objective response rate and duration of response in a single arm study. an improvement in survival or disease-related symptoms has not been established.,oesophageal squamous cell carcinoma (oscc),opdivo in combination with ipilimumab is indicated for the first-line treatment of patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ? 1% as determined by a validated test.,opdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ? 1% as determined by a validated test.,opdivo, as monotherapy, is indicated for the treatment of patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine and platinum based chemotherapy.,adjuvant oesophageal cancer (oc) or gastro-oesophageal junction cancer (gojc),opdivo, as monotherapy, is indicated for the adjuvant treatment of resected oesophageal or gastro-oesophageal junction cancer in patients who have received neoadjuvant chemoradiotherapy. gastric cancer (gc), gastro-oesophageal junction cancer (gojc), or oesophageal adenocarcinoma (oac),opdivo, in combination with fluoropyrimidine- and platinum-based combination chemotherapy, is indicated for the first-line treatment of patients with her2 negative advanced or metastatic gastric or gastro-oesophageal junction or oesophageal adenocarcinoma.

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

bristol-myers squibb australia pty ltd - nivolumab, quantity: 47 mg - injection, concentrated - excipient ingredients: sodium chloride; water for injections; pentetic acid; sodium citrate dihydrate; sodium hydroxide; mannitol; hydrochloric acid; polysorbate 80 - melanoma,opdivo, as monotherapy, is indicated for the adjuvant treatment of adults and adolescent patients 12 years and older with completely resected stage iib, iic, iii or iv melanoma.,opdivo, as monotherapy, is indicated for the treatment of patients with unresectable or metastatic melanoma.,opdivo, in combination with ipilimumab, is indicated for the treatment of patients with unresectable or metastatic melanoma. the approval of this indication is based on a pre-specified comparison to ipilimumab monotherapy. all analyses comparing nivolumab monotherapy with the nivolumab/ipilimumab combination are descriptive.,non-small cell lung cancer (nsclc),opdivo, in combination with platinum-doublet chemotherapy, is indicated for the neoadjuvant treatment of patients with resectable non-small cell lung cancer (nsclc).,opdivo, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer (nsclc) with no egfr or alk genomic tumour aberrations.,opdivo, as monotherapy, is indicated for the treatment of locally advanced or metastatic squamous non-small cell lung cancer (nsclc) with progression on or after prior chemotherapy.,opdivo, as monotherapy, is indicated for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (nsclc) with progression on or after prior chemotherapy. in patients with tumour egfr or alk genomic aberrations, opdivo should be used after progression on or after targeted therapy.,malignant pleural mesothelioma (mpm),opdivo, in combination with ipilimumab, is indicated for the first-line treatment of patients with unresectable malignant pleural mesothelioma.,renal cell carcinoma (rcc),opdivo, in combination with ipilimumab, is indicated for the treatment of patients with intermediate/poor-risk, previously untreated advanced renal cell carcinoma.,opdivo, in combination with cabozantinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma.,opdivo, as monotherapy, is indicated for the treatment of patients with advanced clear cell renal cell carcinoma after prior anti-angiogenic therapy.,classical hodgkin lymphoma (chl),opdivo, as monotherapy, is indicated for the treatment of patients with relapsed or refractory classical hodgkin lymphoma (chl) after autologous stem cell transplant and treatment with brentuximab vedotin. the approval of this indication is based on objective response rate in a single arm study.,squamous cell carcinoma of the head and neck (scchn),opdivo, as monotherapy, is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in patients progressing on or after platinum based therapy.,urothelial carcinoma (uc),opdivo, as monotherapy, is indicated for the adjuvant treatment of patients with muscle invasive urothelial carcinoma (miuc) who are at high risk of recurrence after undergoing radical resection of miuc.,opdivo, as monotherapy, is indicated for the treatment of patients with locally advanced unresectable or metastatic urothelial carcinoma after prior platinum-containing therapy. the approval of this indication is based on objective response rate and duration of response in a single arm study.,hepatocellular carcinoma (hcc),opdivo, as monotherapy, is indicated for the treatment of patients with hepatocellular carcinoma after prior sorafenib therapy. this indication is approved based on objective response rate and duration of response in a single arm study. an improvement in survival or disease-related symptoms has not been established.,oesophageal squamous cell carcinoma (oscc),opdivo in combination with ipilimumab is indicated for the first-line treatment of patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ? 1% as determined by a validated test.,opdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ? 1% as determined by a validated test.,opdivo, as monotherapy, is indicated for the treatment of patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine and platinum based chemotherapy.,adjuvant oesophageal cancer (oc) or gastro-oesophageal junction cancer (gojc),opdivo, as monotherapy, is indicated for the adjuvant treatment of resected oesophageal or gastro-oesophageal junction cancer in patients who have received neoadjuvant chemoradiotherapy.,gastric cancer (gc), gastro-oesophageal junction cancer (gojc), or oesophageal adenocarcinoma (oac),opdivo, in combination with fluoropyrimidine- and platinum-based combination chemotherapy, is indicated for the first-line treatment of patients with her2 negative advanced or metastatic gastric or gastro-oesophageal junction or oesophageal adenocarcinoma.

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

roche products pty ltd - atezolizumab, quantity: 840 mg - injection, concentrated - excipient ingredients: histidine; glacial acetic acid; polysorbate 20; sucrose; water for injections - early-stage non-small cell lung cancer,tecentriq as monotherapy is indicated as adjuvant treatment following complete resection and no progression after platinum-based adjuvant chemotherapy for adult patients with stage ii to iiia (as per 7th edition of the uicc/ajcc staging system) nsclc whose tumours have pd-l1 expression on greater than or equal to 50% of tumour cells.,metastatic non-small cell lung cancer,tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous non-small cell lung cancer (nsclc). in patients with egfr mutant or alk-positive nsclc, tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies.,tecentriq, in combination with nanoparticle albumin-bound paclitaxel (nab-paclitaxel) and carboplatin, is indicated for first-line treatment of patients with metastatic non-squamous nsclc who do not have tumour egfr or alk genomic aberrations.,tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic nsclc after prior chemotherapy. patients with egfr mutant or alk-positive nsclc should also have received targeted therapies before receiving tecentriq.,small cell lung cancer,tecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of patients with extensive-stage small cell lung cancer (es-sclc).,urothelial carcinoma,tecentriq is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who,? are considered cisplatin ineligible and whose tumours express pd-l1 (pd-l1 stained tumour-infiltrating immune cells [ic] covering greater than or equal to 5% of the tumour area), as determined by a validated test, or,? are considered ineligible for any other platinum-containing chemotherapy regardless of the level of tumour pd-l1 expression.,this indication is approved based on overall response rate and duration of response in a single-arm study. improvements in overall survival, progression-free survival, or health-related quality of life have not been established.,hepatocellular carcinoma,tecentriq, in combination with bevacizumab, is indicated for the treatment of patients with unresectable or metastatic hepatocellular carcinoma (hcc) who have not received prior systemic therapy.

Israel - English - Ministry of Health

eli lilly israel ltd, israel - abemaciclib - film coated tablets - abemaciclib 100 mg - abemaciclib - verzenio™ (abemaciclib) is indicated:•in combination with a non-steroidal aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer.•in combination with fulvestrant for the treatment of women with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.•as monotherapy for the treatment of adult patients with hr-positive, her2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy in the metastatic setting and prior chemotherapy in the metastatic setting including taxane in adjuvant or metastatic setting.verzenio should not be used in women after prior treatment with cyclin-dependent kinases 4 and 6 (cdk4 and cdk6) inhibitor.• verzenio in combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2) negative, node positive early breast cancer at high risk of recurrence.in pre- or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (lhrh) agonist.