Malta - engleză - Medicines Authority

ascend gmbh c/o pollux business center gmbh sebastian-kneipp-straße 41, 60439 frankfurt am main, germany - tablet - everolimus 0.75 mg - immunosuppressants

Malta - engleză - Medicines Authority

ascend gmbh c/o pollux business center gmbh sebastian-kneipp-straße 41, 60439 frankfurt am main, germany - tablet - everolimus 1 mg - immunosuppressants

Australia - engleză - 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.

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

novartis pharmaceuticals australia pty ltd - everolimus, quantity: 3 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.

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

novartis pharmaceuticals australia pty ltd - everolimus, quantity: 2 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.

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

novartis pharmaceuticals australia pty ltd - everolimus, quantity: 2.5 mg - tablet - excipient ingredients: magnesium stearate; lactose; lactose monohydrate; hypromellose; butylated hydroxytoluene; crospovidone - 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. ? progressive, unresectable or metastatic, well or moderately differentiated neuroendocrine tumours (nets) of pancreatic origin. ? progressive, unresectable or metastatic, well-differentiated, non-functional neuroendocrine tumours (net) of gastrointestinal or lung origin in adults. ? 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. 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.

Israel - engleză - 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 - engleză - 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 - engleză - 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

Malta - engleză - Medicines Authority

reddy pharma iberia s.a. avinguda de josep tarradellas 38 barcelona, 08029, spain - tablet - everolimus 2.5 mg - antineoplastic agents