Israel - English - 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

Israel - English - Ministry of Health

abic marketing ltd, israel - everolimus - tablets - everolimus 2.5 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

Israel - English - Ministry of Health

abic marketing ltd, israel - everolimus - tablets - everolimus 5 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

Israel - English - Ministry of Health

abic marketing ltd, israel - everolimus - tablets - everolimus 7.5 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

Israel - English - Ministry of Health

taro international 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 taro 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 taro 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 taro is indicated for the treatment of adult patients with renal angiomyolipoma and tuberous sclerosis complex (tsc), not requiring immediate surgery. the effectiveness of everolimus taro 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 taro 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

taro international ltd, israel - everolimus - tablets - everolimus 2.5 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 taro 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 taro 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 taro is indicated for the treatment of adult patients with renal angiomyolipoma and tuberous sclerosis complex (tsc), not requiring immediate surgery. the effectiveness of everolimus taro 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 taro 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

taro international ltd, israel - everolimus - tablets - everolimus 5 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 taro 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 taro 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 taro is indicated for the treatment of adult patients with renal angiomyolipoma and tuberous sclerosis complex (tsc), not requiring immediate surgery. the effectiveness of everolimus taro 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 taro 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.

Malta - English - Medicines Authority

genthon bv microweg 22, 6545 cm nijmegen, netherlands - everolimus - tablet - everolimus 2.5 mg - antineoplastic agents

Malta - English - Medicines Authority

genthon bv microweg 22, 6545 cm nijmegen, netherlands - everolimus - tablet - everolimus 5 mg - antineoplastic agents

Malta - English - Medicines Authority

genthon bv microweg 22, 6545 cm nijmegen, netherlands - everolimus - tablet - everolimus 10 mg/2ml - antineoplastic agents