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

amgen inc - etelcalcetide hydrochloride (unii: 72pt5993du) (etelcalcetide - unii:60me133fjb) - etelcalcetide 2.5 mg in 0.5 ml - parsabiv is indicated for the treatment of secondary hyperparathyroidism (hpt) in adult patients with chronic kidney disease (ckd) on hemodialysis. limitations of use: parsabiv has not been studied in adult patients with parathyroid carcinoma, primary hyperparathyroidism, or with chronic kidney disease who are not on hemodialysis and is not recommended for use in these populations. hypersensitivity parsabiv is contraindicated in patients with known hypersensitivity to etelcalcetide or any of its excipients. hypersensitivity reactions, including face edema and anaphylactic reaction, have occurred with parsabiv [see adverse reactions (6)] . risk summary there are no available data on the use of parsabiv in pregnant women. in animal reproduction studies, effects were seen at doses associated with maternal toxicity that included hypocalcemia. in a pre- and post-natal study in rats administered etelcalcetide during organogenesis through delivery and weaning, there was a slight increase in perinatal pup mortality,

Singapore - English - HSA (Health Sciences Authority)

amgen biotechnology singapore pte ltd - etelcalcetide hydrochloride 11.54 mg eqv etelcalcetide - injection, solution - etelcalcetide hydrochloride 11.54 mg eqv etelcalcetide 10 mg/2 ml

Singapore - English - HSA (Health Sciences Authority)

amgen biotechnology singapore pte ltd - etelcalcetide hydrochloride 2.88 mg eqv etelcalcetide - injection, solution - etelcalcetide hydrochloride 2.88 mg eqv etelcalcetide 2.5 mg/0.5 ml

Singapore - English - HSA (Health Sciences Authority)

amgen biotechnology singapore pte ltd - etelcalcetide hydrochloride 5.77 mg eqv etelcalcetide - injection, solution - etelcalcetide hydrochloride 5.77 mg eqv etelcalcetide 5 mg/ml

Israel - English - Ministry of Health

amgen europe b.v. - etelcalcetide as hydrochloride - solution for injection - etelcalcetide as hydrochloride 5 mg / 1 ml - etelcalcetide - parsabiv is indicated for the treatment of secondary hyperparathyroidism (shpt) in adult patients with chronic kidney disease (ckd) on hemodialysis therapy.

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

amgen ltd - etelcalcetide hydrochloride - solution for injection - 5mg/1ml

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

amgen ltd - etelcalcetide hydrochloride - solution for injection - 5mg/1ml

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

amgen ltd - etelcalcetide hydrochloride - solution for injection - 5mg/1ml

European Union - English - EMA (European Medicines Agency)

amgen europe b.v. - etelcalcetide hydrochloride - hyperparathyroidism, secondary - anti-parathyroid agents, calcium homeostasis - parsabiv is indicated for the treatment of secondary hyperparathyroidism (shpt) in adult patients with chronic kidney disease (ckd) on haemodialysis therapy.

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

amgen biopharmaceuticals malaysia sdn bhd - etelcalcetide hydrochloride -