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

takeda pharmaceuticals america, inc. - lanadelumab (unii: 2372v1tkxk) (lanadelumab - unii:2372v1tkxk) - takhzyro® is indicated for prophylaxis to prevent attacks of hereditary angioedema (hae) in adult and pediatric patients aged 2 years and older. none. risk summary there are no available data on takhzyro use in pregnant women to inform any drug associated risks. monoclonal antibodies such as lanadelumab-flyo are transported across the placenta during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy. an enhanced pre-and postnatal development (eppnd) study conducted in pregnant monkeys at doses resulting in exposures of up to 33 times the exposure achieved (on an auc basis) at the maximum recommended human dose (mrhd) revealed no evidence of harm to the developing fetus. the 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 to 4% and 15

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

takeda pharmaceuticals australia pty ltd - lanadelumab, quantity: 300 mg - injection, solution - excipient ingredients: citric acid monohydrate; water for injections; dibasic sodium phosphate dihydrate; polysorbate 80; histidine; sodium chloride - takhzyro is indicated for routine prevention of recurrent attacks of hereditary angioedema (c1-esterase-inhibitor deficiency or dysfunction) in patients aged 12 years and older.

Israel - English - Ministry of Health

takeda israel ltd - lanadelumab - solution for injection - lanadelumab 150 mg/ml - lanadelumab - takhzyro is indicated for routine prevention of recurrent attacks of hereditary angioedema (hae)in patients aged 2 years and older.

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

takeda pharmaceuticals australia pty ltd - lanadelumab, quantity: 300 mg - injection, solution - excipient ingredients: citric acid monohydrate; water for injections; dibasic sodium phosphate dihydrate; polysorbate 80; histidine; sodium chloride - takhzyro is indicated for routine prevention of recurrent attacks of hereditary angioedema (c1-esterase-inhibitor deficiency or dysfunction) in patients aged 12 years and older.

European Union - English - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - lanadelumab - angioedemas, hereditary - other hematological agents - takhzyro is indicated for routine prevention of recurrent attacks of hereditary angioedema (hae) in patients aged 2 years and older.

Canada - English - Health Canada

takeda canada inc - lanadelumab - solution - 300mg - lanadelumab 300mg - complement inhibitors

Canada - English - Health Canada

takeda canada inc - lanadelumab - solution - 300mg - lanadelumab 300mg - complement inhibitors

New Zealand - English - Medsafe (Medicines Safety Authority)

takeda new zealand limited - lanadelumab 150 mg/ml;   - solution for injection - 300 mg/2ml - active: lanadelumab 150 mg/ml   excipient: citric acid monohydrate dibasic sodium phosphate dihydrate histidine polysorbate 80 sodium chloride water for injection - takhzyro is indicated for routine prevention of recurrent attacks of hereditary angiodema (c1-esterase-inhibitor deficiency or dysfunction) in patients aged 12 years or older.

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

takeda pharmaceuticals international ag, ireland - lanadelumab - solution for injection - 300 mg

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

takeda pharmaceuticals international ag, ireland - lanadelumab - solution for injection - 300 mg,