Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

kyowa kirin holdings b.v., netherlands - granisetron - transdermal patch - 34.3 mg

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

aspen pharmacare australia pty ltd - triamcinolone acetonide, quantity: 0.2 mg/g - ointment - excipient ingredients: white soft paraffin - indications as at 22 october 1998: in the treatment of the following dermatoses: atopic dermatitis, eczematous dermatitis, nummular eczema, contact dermatitis, anal and vulval pruritus, otitis externa, seborrhoeic dermatitis, exzematised psoriasis, neurodermatitis.

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

aspen pharmacare australia pty ltd - triamcinolone acetonide, quantity: 0.2 mg/g - cream - excipient ingredients: emulsifying wax; benzyl alcohol; lactic acid; purified water; glycerol; sorbitol solution (70 per cent) (non-crystallising); isopropyl palmitate - indications as at 22 october 1998: in the treatment of the following dermatoses: atopic dermatitis, eczematous dermatitis, nummular eczema, contact dermatitis, anal and vulval pruritus, otitis externa, seborrhoeic dermatitis, exzematised psoriasis, neurodermatitis.

European Union - English - EMA (European Medicines Agency)

glaxo group ltd. - amprenavir - hiv infections - antivirals for systemic use - agenerase, in combination with other antiretroviral agents, is indicated for the treatment of protease inhibitor (pi) experienced hiv-1 infected adults and children above the age of 4 years. agenerase capsules should normally be administered with low dose ritonavir as a pharmacokinetic enhancer of amprenavir (see sections 4.2 and 4.5). the choice of amprenavir should be based on individual viral resistance testing and treatment history of patients (see section 5.1).the benefit of agenerase boosted with ritonavir has not been demonstrated in pi nave patients (see section 5.1)

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 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 - 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)

bayer australia ltd - rivaroxaban, quantity: 10 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; sodium lauryl sulfate; croscarmellose sodium; hypromellose; lactose monohydrate; iron oxide red; titanium dioxide; macrogol 3350; magnesium stearate - xarelto is indicated for: ? prevention of venous thromboembolism (vte) in adult patients who have undergone major orthopaedic surgery of the lower limbs (elective total hip replacement, treatment for up to 5 weeks; elective total knee replacement, treatment for up to 2 weeks) ? prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and at least one additional risk factor for stroke ? treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe) and for the prevention of recurrent dvt and pe,xarelto, in combination with aspirin, is indicated for ? the prevention of major cardiovascular events (composite of stroke, myocardial infarction and cardiovascular death) in patients with coronary artery disease (cad) and/or peripheral artery disease (pad).

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

bayer australia ltd - rivaroxaban, quantity: 20 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; croscarmellose sodium; hypromellose; lactose monohydrate; magnesium stearate; sodium lauryl sulfate; iron oxide red; macrogol 3350; titanium dioxide - xarelto is indicated for: ? prevention of venous thromboembolism (vte) in adult patients who have undergone major orthopaedic surgery of the lower limbs (elective total hip replacement, treatment for up to 5 weeks; elective total knee replacement, treatment for up to 2 weeks) ? prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and at least one additional risk factor for stroke ? treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe) and for the prevention of recurrent dvt and pe,xarelto, in combination with aspirin, is indicated for ? the prevention of major cardiovascular events (composite of stroke, myocardial infarction and cardiovascular death) in patients with coronary artery disease (cad) and/or peripheral artery disease (pad).

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

bayer australia ltd - rivaroxaban, quantity: 15 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; croscarmellose sodium; hypromellose; lactose monohydrate; magnesium stearate; sodium lauryl sulfate; iron oxide red; macrogol 3350; titanium dioxide - xarelto is indicated for: ? prevention of venous thromboembolism (vte) in adult patients who have undergone major orthopaedic surgery of the lower limbs (elective total hip replacement, treatment for up to 5 weeks; elective total knee replacement, treatment for up to 2 weeks) ? prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and at least one additional risk factor for stroke ? treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe) and for the prevention of recurrent dvt and pe,xarelto, in combination with aspirin, is indicated for ? the prevention of major cardiovascular events (composite of stroke, myocardial infarction and cardiovascular death) in patients with coronary artery disease (cad) and/or peripheral artery disease (pad).