Canada - English - Health Canada

alnylam netherlands b.v. - vutrisiran (vutrisiran sodium) - solution - 25mg - vutrisiran (vutrisiran sodium) 25mg

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

alnylam pharmaceuticals, inc. - vutrisiran (unii: gb4i2ji8ui) (vutrisiran - unii:gb4i2ji8ui) - amvuttra is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. none. risk summary there are no available data on amvuttra use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. amvuttra treatment leads to a decrease in serum vitamin a levels, and vitamin a supplementation is advised for patients taking amvuttra. vitamin a is essential for normal embryofetal development; however, excessive levels of vitamin a are associated with adverse developmental effects. the effects on the fetus of a reduction in maternal serum ttr caused by amvuttra and of vitamin a supplementation are unknown [see warnings and precautions (5.1) and clinical pharmacology (12.2)] . in animal studies, subcutaneous administration of vutrisiran to pregnant rats resulted in developmental toxicity (reduced fetal body weight and embryofetal mortality) at doses associated with maternal toxicity (see data) . in the u.s. general population, the estimated

European Union - English - EMA (European Medicines Agency)

alnylam netherlands b.v. - vutrisiran sodium - amyloid neuropathies, familial - other nervous system drugs - treatment of hereditary transthyretin-mediated amyloidosis (hattr amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.

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

alnylam australia pty ltd - patisiran, quantity: 10 mg - injection, concentrated - excipient ingredients: peg2000-c-dmg; sodium chloride; dlin-mc3-dma; water for injections; monobasic potassium phosphate; dibasic sodium phosphate heptahydrate; cholesterol; distearoylphosphatidylcholine - onpattro is indicated for the treatment of hereditary transthyretin-mediated amyloidosis (hattr amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.

Israel - English - Ministry of Health

medison pharma ltd - patisiran as sodium - concentrate for solution for infusion - patisiran as sodium 2 mg / 1 ml - patisiran - onpattro is indicated for the treatment of hereditary transthyretin-mediated amyloidosis (hattr amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy

European Union - English - EMA (European Medicines Agency)

alnylam netherlands b.v. - patisiran sodium - amyloidosis, familial - other nervous system drugs - onpattro is indicated for the treatment of hereditary transthyretin-mediated amyloidosis (hattr amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.

Canada - English - Health Canada

alnylam netherlands b.v. - patisiran (patisiran sodium) - solution - 2mg - patisiran (patisiran sodium) 2mg - other miscellaneous therapeutic agents

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

alnylam pharmaceuticals, inc. - patisiran sodium (unii: wo0ym16lkg) (patisiran - unii:50fkx8cb2y) - onpattro is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to onpattro during pregnancy. physicians are encouraged to enroll pregnant patients, or pregnant women may register themselves in the program by calling 1-877-256-9526 or by contacting alnylampregnancyprogram@iqvia.com. risk summary there are no available data on onpattro use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. onpattro treatment leads to a decrease in serum vitamin a levels, and vitamin a supplementation is advised for patients taking onpattro. vitamin a is essential for normal embryofetal development; however, excessive levels of vitamin a are associated with adverse developmental effects. the effects on the fetus of a reduction in maternal serum ttr caused by onpattro and of vitamin a supplementation are unknown [see

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

laboratoires nutrisanté - ascorbic acid 700 mg; sodium ascorbate 338 mg - eq. ascorbic acid 300 mg - chewable tablet - 1000 mg - ascorbic acid 700 mg; sodium ascorbate 338 mg - ascorbic acid (vit c)

India - English - Central Drugs Standard Control Organization

novartis - cap - 30