United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

novartis pharmaceuticals uk ltd - everolimus - tablet - 10mg

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

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - everolimus 10mg;  ;   - tablet - 10 mg - active: everolimus 10mg     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.

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 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 - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - everolimus, quantity: 10 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 t

European Union - English - EMA (European Medicines Agency)

novartis europharm limited - everolimus - carcinoma, renal cell; breast neoplasms; pancreatic neoplasms - antineoplastic agents - hormone-receptor-positive advanced breast cancerafinitor is indicated for the treatment of hormone-receptor-positive, her2/neu-negative advanced breast cancer, in combination with exemestane, in post-menopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor.neuroendocrine tumours of pancreatic originafinitor is indicated for the treatment of unresectable or metastatic, well or moderately differentiated neuroendocrine tumours of pancreatic origin in adults with progressive disease.neuroendocrine tumours of gastrointestinal or lung originafinitor is indicated for the treatment of unresectable or metastatic, well-differentiated (grade 1 or grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease.renal-cell carcinomaafinitor is indicated for the treatment of patients with advanced renal-cell carcinoma, whose disease has progressed on or after treatment with vegf-targeted therapy.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

novartis pharmaceuticals uk ltd - everolimus - tablet - 5mg

United States - English - 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.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

novartis pharmaceuticals uk ltd - everolimus - tablet - 10mg