Israel - English - Ministry of Health

novartis israel ltd - everolimus - tablets - everolimus 5 mg - everolimus - everolimus - - for the treatment of patients with sega associated with tuberous sclerosis complex (tsc) who require therapeutic intervention but are not candidates for curative surgical resection.the effectiveness of afinitor is based on an analysis of change in sega volume. clinical benefit such as improvement in disease-related symptoms or increase in overall survival has not been demonstrated.- treatment of progressive neuroendocrine tumors of pancreatic origin (pnet) in patients with unresectable, locally advanced or metastatic disease.the safety and effectiveness of afinitor® in the treatment of patients with carcinoid tumors have not been established.- for the treatment of hormone receptor – positive, her2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression follwing a non – steroidal aromatase inhibitor.- afinitor ® is indicated for the treatment of adult patients with renal angiomyolipoma and tuberous sclerosis complex (tsc), not requiring immediate surgery. the effectiveness of afinitor in treatment of renal angiomyolipoma is based on an analysis of durable objective responses in patients treated for a median of 8.3 months. further follow-up of patients is required to determine long-term outcomes.- afinitor ® is indicated for the treatment of patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with vegf-targeted therapy.- treatment of unresectable, locally advanced or metastatic, well-differentiated (grade 1 or grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease

Israel - English - Ministry of Health

novartis israel ltd - everolimus - tablets - everolimus 10 mg - everolimus - everolimus - - for the treatment of patients with sega associated with tuberous sclerosis complex (tsc) who require therapeutic intervention but are not candidates for curative surgical resection.the effectiveness of afinitor is based on an analysis of change in sega volume. clinical benefit such as improvement in disease-related symptoms or increase in overall survival has not been demonstrated.- treatment of progressive neuroendocrine tumors of pancreatic origin (pnet) in patients with unresectable, locally advanced or metastatic disease.the safety and effectiveness of afinitor® in the treatment of patients with carcinoid tumors have not been established.- for the treatment of hormone receptor – positive, her2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression follwing a non – steroidal aromatase inhibitor.- afinitor ® is indicated for the treatment of adult patients with renal angiomyolipoma and tuberous sclerosis complex (tsc), not requiring immediate surgery. the effectiveness of afinitor in treatment of renal angiomyolipoma is based on an analysis of durable objective responses in patients treated for a median of 8.3 months. further follow-up of patients is required to determine long-term outcomes.- afinitor ® is indicated for the treatment of patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with vegf-targeted therapy.- treatment of unresectable, locally advanced or metastatic, well-differentiated (grade 1 or grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease

Israel - English - Ministry of Health

novartis israel ltd - everolimus - tablets - everolimus 2.5 mg - everolimus - everolimus - - for the treatment of patients with sega associated with tuberous sclerosis complex (tsc) who require therapeutic intervention but are not candidates for curative surgical resection.the effectiveness of afinitor is based on an analysis of change in sega volume. clinical benefit such as improvement in disease-related symptoms or increase in overall survival has not been demonstrated.- treatment of progressive neuroendocrine tumors of pancreatic origin (pnet) in patients with unresectable, locally advanced or metastatic disease.the safety and effectiveness of afinitor® in the treatment of patients with carcinoid tumors have not been established.- for the treatment of hormone receptor – positive, her2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression follwing a non – steroidal aromatase inhibitor.- afinitor ® is indicated for the treatment of adult patients with renal angiomyolipoma and tuberous sclerosis complex (tsc), not requiring immediate surgery. the effectiveness of afinitor in treatment of renal angiomyolipoma is based on an analysis of durable objective responses in patients treated for a median of 8.3 months. further follow-up of patients is required to determine long-term outcomes.- afinitor ® is indicated for the treatment of patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with vegf-targeted therapy.- treatment of unresectable, locally advanced or metastatic, well-differentiated (grade 1 or grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease

European Union - English - EMA (European Medicines Agency)

eli lilly nederland b.v. - necitumumab - carcinoma, non-small-cell lung - antineoplastic agents - portrazza in combination with gemcitabine and cisplatin chemotherapy is indicated for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (egfr) expressing squamous non-small cell lung cancer who have not received prior chemotherapy for this condition.

European Union - English - EMA (European Medicines Agency)

accord healthcare s.l.u. - zoledronic acid monohydrate - hypercalcemia; fractures, bone; cancer - bisphosphonates - prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone.treatment of adult patients with tumour-induced hypercalcaemia (tih).

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

medis pharma pty ltd - everolimus, quantity: 10 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)

medis pharma 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)

medis pharma 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)

medis pharma 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)

teva pharma australia pty ltd - everolimus, quantity: 10 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.