European Union - English - EMA (European Medicines Agency)

a.c.o.m. - advanced center oncology - copper (64cu) chloride - radionuclide imaging - various diagnostic radiopharmaceuticals - cuprymina is a radiopharmaceutical precursor. it is not intended for direct use in patients. this medicinal product must be used only for the radiolabelling of carrier molecules, which have been specifically developed and authorised for radiolabelling with this radionuclide.

European Union - English - EMA (European Medicines Agency)

accord healthcare s.l.u. - filgrastim - neutropenia - immunostimulants, - grastofil is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia.the safety and efficacy of grastofil are similar in adults and children receiving cytotoxic chemotherapy.grastofil is indicated for the mobilisation of peripheral blood progenitor cells (pbpcs).in patients, children or adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (anc) of ≤ 0.5 x 109/l, and a history of severe or recurrent infections, long term administration of grastofil is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.grastofil is indicated for the treatment of persistent neutropenia (anc less than or equal to 1.0 x 109/l) in patients with advanced hiv infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.

Australia - English - 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 - English - 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 - English - 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 - English - 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 - English - Ministry of Health

pfizer pharmaceuticals israel ltd - crizotinib - capsules - crizotinib 200 mg - crizotinib - crizotinib - xalkori is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (nsclc) that is anaplastic lymphoma kinase (alk)-positive. xalkori is indicated for the treatment of patients with metastatic nsclc whose tumors are ros1-positive.

Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - crizotinib - capsules - crizotinib 200 mg - crizotinib - crizotinib - xalkori is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (nsclc) that is anaplastic lymphoma kinase (alk)-positive. xalkori is indicated for the treatment of patients with metastatic nsclc whose tumors are ros1-positive.

Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - crizotinib - capsules - crizotinib 250 mg - crizotinib - crizotinib - xalkori is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (nsclc) that is anaplastic lymphoma kinase (alk)-positive. xalkori is indicated for the treatment of patients with metastatic nsclc whose tumors are ros1-positive.

Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - crizotinib - capsules - crizotinib 250 mg - crizotinib - crizotinib - xalkori is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (nsclc) that is anaplastic lymphoma kinase (alk)-positive. xalkori is indicated for the treatment of patients with metastatic nsclc whose tumors are ros1-positive.