Israel - English - Ministry of Health

medison pharma ltd - pasireotide as embonate - powder and solvent for suspension for injection - pasireotide as embonate 20 mg/vial - pasireotide - signifor lar is indicated for the treatment of adult patients with acromegaly for whom surgery is not an option or has not been curative and who are inadequately controlled on treatment with another somatostatin analogue.treatment of adult patients with cushing’s disease for whom surgery is not an option or for whom surgery has failed.

Israel - English - Ministry of Health

medison pharma ltd - pasireotide as embonate - powder and solvent for suspension for injection - pasireotide as embonate 40 mg/vial - pasireotide - signifor lar is indicated for the treatment of adult patients with acromegaly for whom surgery is not an option or has not been curative and who are inadequately controlled on treatment with another somatostatin analogue.treatment of adult patients with cushing’s disease for whom surgery is not an option or for whom surgery has failed.

Israel - English - Ministry of Health

medison pharma ltd - pasireotide as embonate - powder and solvent for suspension for injection - pasireotide as embonate 60 mg/vial - pasireotide - signifor lar is indicated for the treatment of adult patients with acromegaly for whom surgery is not an option or has not been curative and who are inadequately controlled on treatment with another somatostatin analogue.

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

recordati rare diseases australia pty ltd - pasireotide embonate, quantity: 82.26 mg (equivalent: pasireotide, qty 60 mg) - injection, modified release - excipient ingredients: polyglactin glucose; polyglactin - signifor lar is indicated for the treatment of adult patients with acromegaly for whom surgery is not an option or has not been curative or who are inadequately controlled on treatment with other somatostatin analogues.

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

recordati rare diseases australia pty ltd - pasireotide embonate, quantity: 54.84 mg (equivalent: pasireotide, qty 40 mg) - injection, modified release - excipient ingredients: polyglactin glucose; polyglactin - signifor lar is indicated for the treatment of adult patients with acromegaly for whom surgery is not an option or has not been curative or who are inadequately controlled on treatment with other somatostatin analogues.

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

recordati rare diseases australia pty ltd - pasireotide embonate, quantity: 27.42 mg (equivalent: pasireotide, qty 20 mg) - injection, modified release - excipient ingredients: polyglactin glucose; polyglactin - signifor lar is indicated for the treatment of adult patients with acromegaly for whom surgery is not an option or has not been curative or who are inadequately controlled on treatment with other somatostatin analogues.

United States - English - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - pasireotide (unii: 98h1t17066) (pasireotide - unii:98h1t17066) - pasireotide 0.3 mg in 1 ml - signifor is indicated for the treatment of adult patients with cushing's disease for whom pituitary surgery is not an option or has not been curative. none. risk summary the limited data with signifor in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. in embryo-fetal development studies in rabbits, findings indicating developmental delay were observed with subcutaneous administration of pasireotide during organogenesis at doses less than the exposure in humans at the highest recommended dose; maternal toxicity was not observed at this dose (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively. data animal data in embryo-fetal development studies in rats given 1, 5, and 10 mg/kg/day subcutaneously throughout organog

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

recordati rare diseases australia pty ltd - pasireotide diaspartate, quantity: 1128.6 microgram (equivalent: pasireotide, qty 900 microgram) - injection, solution - excipient ingredients: mannitol; water for injections; sodium hydroxide; tartaric acid - the treatment of adult patients with cushing?s disease for whom surgery is not an option or for whom surgery has failed.

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

recordati rare diseases australia pty ltd - pasireotide diaspartate, quantity: 376.2 microgram (equivalent: pasireotide, qty microgram) - injection, solution - excipient ingredients: water for injections; mannitol; tartaric acid; sodium hydroxide - the treatment of adult patients with cushing?s disease for whom surgery is not an option or for whom surgery has failed.

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

recordati rare diseases australia pty ltd - pasireotide diaspartate, quantity: 752.4 microgram (equivalent: pasireotide, qty 600 microgram) - injection, solution - excipient ingredients: water for injections; sodium hydroxide; tartaric acid; mannitol - the treatment of adult patients with cushing?s disease for whom surgery is not an option or for whom surgery has failed.