Australia - Kiingereza - 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.

Australia - Kiingereza - 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 - Kiingereza - 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.

Marekani - Kiingereza - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - everolimus (unii: 9hw64q8g6g) (everolimus - unii:9hw64q8g6g) - everolimus 5 mg - afinitor® is indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, her2-negative breast cancer in combination with exemestane, after failure of treatment with letrozole or anastrozole. afinitor is indicated for the treatment of adult patients with progressive neuroendocrine tumors of pancreatic origin (pnet) with unresectable, locally advanced or metastatic disease. afinitor is indicated for the treatment of adult patients with progressive, well-differentiated, non-functional net of gastrointestinal (gi) or lung origin with unresectable, locally advanced or metastatic disease. limitations of use: afinitor is not indicated for the treatment of patients with functional carcinoid tumors [see clinical studies (14.2)] . afinitor is indicated for the treatment of adult patients with advanced rcc after failure of treatment with sunitinib or sorafenib. afinitor is indicated for the treatment of adult patients with renal angiomyolipoma and tsc, not requiring immediate surgery.

Marekani - Kiingereza - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - everolimus (unii: 9hw64q8g6g) (everolimus - unii:9hw64q8g6g) - everolimus tablets for oral suspension are indicated in adult and pediatric patients aged 1 year and older with tsc for the treatment of sega that requires therapeutic intervention but cannot be curatively resected. everolimus tablets for oral suspension are indicated for the adjunctive treatment of adult and pediatric patients aged 2 years and older with tsc-associated partial-onset seizures. everolimus tablets for oral suspension are contraindicated in patients with clinically significant hypersensitivity to everolimus or to other rapamycin derivatives [see warnings and precautions (5.3)] . based on animal studies and the mechanism of action [see clinical pharmacology (12.1)] , everolimus tablets for oral suspension can cause fetal harm when administered to a pregnant woman. there are limited case reports of afinitor use in pregnant women; however, these reports are not sufficient to inform about risks of birth defects or miscarriage. in animal studies, everolimus caused embryo-fetal toxicities in rats when

Nyuzilandi - Kiingereza - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - everolimus 5mg;  ;   - tablet - 5 mg - active: everolimus 5mg     excipient: butylated hydroxytoluene crospovidone hypromellose lactose lactose monohydrate magnesium stearate - the treatment of patients with subependymal giant cell astrocytoma (sega) associated with tuberous sclerosis complex (tsc) who require therapeutic intervention but are not amenable to surgery. the evidence is based on change in sega volume. further clinical benefit, such as improvement of disease-related symptoms, has not been demonstrated.

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

novartis pharmaceuticals australia pty ltd - everolimus, quantity: 5 mg - tablet, dispersible - excipient ingredients: butylated hydroxytoluene; crospovidone; hypromellose; lactose monohydrate; mannitol; magnesium stearate; microcrystalline cellulose; colloidal anhydrous silica - afinitor is indicated for the: ? treatment of postmenopausal women with hormone receptor-positive, her2 negative advanced breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. ? treatment of progressive, unresectable or metastatic, well or moderately differentiated neuroendocrine tumours (nets) of pancreatic origin. ? treatment of progressive, unresectable or metastatic, well-differentiated, non-functional neuroendocrine tumours (net) of gastrointestinal or lung origin in adults. ? treatment of advanced renal cell carcinoma after failure of treatment with sorafenib or sunitinib. ? treatment of subependymal giant cell astrocytoma (sega) associated with tuberous sclerosis complex (tsc) who require therapeutic intervention but are not candidates for curative surgical resection. ? treatment of patients with tuberous sclerosis complex (tsc) who have renal angiomyolipoma not requiring immediate surgery. ? adjunctive treatment of patients aged 2 years and older with tsc and associated refractory seizures.

Israeli - Kiingereza - 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

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

novartis pharmaceuticals australia pty ltd - everolimus, quantity: 5 mg - tablet, uncoated - excipient ingredients: butylated hydroxytoluene; lactose monohydrate; hypromellose; magnesium stearate; crospovidone; lactose - afinitor is indicated for the: ? treatment of postmenopausal women with hormone receptor-positive, her2 negative advanced breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. ? treatment of progressive, unresectable or metastatic, well or moderately differentiated neuroendocrine tumours (nets) of pancreatic origin. ? treatment of progressive, unresectable or metastatic, well-differentiated, non-functional neuroendocrine tumours (net) of gastrointestinal or lung origin in adults. ? treatment of advanced renal cell carcinoma after failure of treatment with sorafenib or sunitinib. ? treatment of subependymal giant cell astrocytoma (sega) associated with tuberous sclerosis complex (tsc) who require therapeutic intervention but are not candidates for curative surgical resection. ? treatment of patients with tuberous sclerosis complex (tsc) who have renal angiomyolipoma not requiring immediate surgery. ? adjunctive treatment of patients aged 2 years and older with tsc and associated refractory seizures.

Israeli - Kiingereza - Ministry of Health

abic marketing ltd, israel - everolimus - tablets - everolimus 10 mg - 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 everolimus 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 everolimus 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.• everolimus teva is indicated for the treatment of adult patients with renal angiomyolipoma and tuberous sclerosis complex (tsc), not requiring immediate surgery. the effectiveness of everolimus 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.• everolimus teva 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