Israel - English - Ministry of Health

medison pharma ltd - pasireotide as diaspartate - solution for injection - pasireotide as diaspartate 0.9 mg/ml - pasireotide - pasireotide - treatment of adult patients with cushing’s disease for whom surgery is not an option or for whom surgery has failed.

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

recordati rare diseases, inc. - pasireotide (unii: 98h1t17066) (pasireotide - unii:98h1t17066) - 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 org

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

novartis pharmaceuticals uk ltd - pasireotide pamoate - powder and solvent for suspension for injection - 20mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

novartis pharmaceuticals uk ltd - pasireotide pamoate - powder and solvent for suspension for injection - 40mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

novartis pharmaceuticals uk ltd - pasireotide pamoate - powder and solvent for suspension for injection - 60mg

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

fta healthcare sdn. bhd. - pasireotide pamoate -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

fta healthcare sdn. bhd. - pasireotide pamoate -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

fta healthcare sdn. bhd. - pasireotide pamoate -

Philippines - English - FDA (Food And Drug Administration)

novartis healthcare philippines, inc.; distributor: novartis healthcare philippines, inc. - pasireotide (as pamoate) - powder and solvent for suspension for injection (im) - 20mg

Philippines - English - FDA (Food And Drug Administration)

novartis healthcare philippines, inc.; distributor: novartis healthcare philippines, inc. - pasireotide (as pamoate) - powder and solvent for suspension for injection (im) - 40mg