Verenigde Staten - Engels - NLM (National Library of Medicine)

natco pharma limited - everolimus (unii: 9hw64q8g6g) (everolimus - unii:9hw64q8g6g) - everolimus is indicated for the prophylaxis of organ rejection in adult patients at low-moderate immunologic risk receiving a kidney transplant [see clinical studies (14.1)]. everolimus is to be administered in combination with basiliximab induction and concurrently with reduced doses of cyclosporine and with corticosteroids. therapeutic drug monitoring (tdm) of everolimus and cyclosporine is recommended for all patients receiving these products [see dosage and administration (2.2, 2.3)] . everolimus is indicated for the prophylaxis of allograft rejection in adult patients receiving a liver transplant. everolimus is to be administered no earlier than 30 days post-transplant concurrently in combination with reduced doses of tacrolimus and with corticosteroids [see warnings and precautions (5.5), clinical studies (14.2)]. tdm of everolimus and tacrolimus is recommended for all patients receiving these products [see dosage and administration (2.3, 2.5)]. the safety and efficacy of everolimus has not been estab

Verenigde Staten - Engels - NLM (National Library of Medicine)

biocon pharma inc. - everolimus (unii: 9hw64q8g6g) (everolimus - unii:9hw64q8g6g) - everolimus tablets are 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. everolimus tablets are indicated for the treatment of adult patients with renal angiomyolipoma and tsc, not requiring immediate surgery. everolimus tablets 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 are contraindicated in patients with clinically significant hypersensitivity to everolimus or to other rapamycin derivatives [see warnings and precautions (5.3)] . risk summary based on animal studies and the mechanism of action [see clinical pharmacology (12.1)] , everolimus tablets can cause fetal harm when administered to a pregnant woman. there are limited case reports of everolimus tablets use in pregnant women; however, these reports ar

Verenigde Staten - Engels - NLM (National Library of Medicine)

ascend laboratories, llc - everolimus (unii: 9hw64q8g6g) (everolimus - unii:9hw64q8g6g) - everolimus tablets are indicated for the prophylaxis of organ rejection in adult patients at low-moderate immunologic risk receiving a kidney transplant [see clinical studies (14.1) ] everolimus tablets are to be administered in combination with basiliximab induction and concurrently with reduced doses of cyclosporine and with corticosteroids. therapeutic drug monitoring (tdm) of everolimus tablets and cyclosporine is recommended for all patients receiving these products. [see dosage and administration (2.2, 2.3) ] everolimus tablets are indicated for the prophylaxis of allograft rejection in adult patients receiving a liver transplant. everolimus tablets are to be administered no earlier than 30 days post-transplant concurrently in combination with reduced doses of tacrolimus and with corticosteroids [see warnings and precautions (5.5), clinical studies (14.2) ]. therapeutic drug monitoring (tdm) of everolimus tablets and tacrolimus is recommended for all patients receiving these products [see dosage and adm

Israël - Engels - 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.

Israël - Engels - 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.

Israël - Engels - Ministry of Health

novartis israel ltd - everolimus - tablets - everolimus 0.5 mg - everolimus - everolimus - kidney and heart transplantationcertican ® is indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving an allogeneic renal or cardiac transplant. in kidney and heart transplantation, certican should be used in combination with ciclosporin for microemulsion and corticosteroids.liver transplantationcertican is indicated for the prophylaxis of organ rejection in adult patients receiving a hepatic transplant. in liver transplantation, certican should be used in combination with tacrolimus and corticosteroids.

Israël - Engels - Ministry of Health

novartis israel ltd - everolimus - tablets - everolimus 0.75 mg - everolimus - everolimus - kidney and heart transplantationcertican ® is indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving an allogeneic renal or cardiac transplant. in kidney and heart transplantation, certican should be used in combination with ciclosporin for microemulsion and corticosteroids.liver transplantationcertican is indicated for the prophylaxis of organ rejection in adult patients receiving a hepatic transplant. in liver transplantation, certican should be used in combination with tacrolimus and corticosteroids.

Israël - Engels - Ministry of Health

novartis israel ltd - everolimus - tablets - everolimus 0.25 mg - everolimus - everolimus - kidney and heart transplantationcertican ® is indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving an allogeneic renal or cardiac transplant. in kidney and heart transplantation, certican should be used in combination with ciclosporin for microemulsion and corticosteroids.liver transplantationcertican is indicated for the prophylaxis of organ rejection in adult patients receiving a hepatic transplant. in liver transplantation, certican should be used in combination with tacrolimus and corticosteroids.

Verenigd Koninkrijk - Engels - MHRA (Medicines & Healthcare Products Regulatory Agency)

novartis pharmaceuticals uk ltd - everolimus - tablet - 5mg

Verenigd Koninkrijk - Engels - MHRA (Medicines & Healthcare Products Regulatory Agency)

novartis pharmaceuticals uk ltd - everolimus - tablet - 5mg