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

takeda pharmaceuticals america, inc. - velaglucerase alfa (unii: 23hye36b0i) (velaglucerase alfa - unii:23hye36b0i) - velaglucerase alfa 2.5 mg in 1 ml - vpriv is indicated for long-term enzyme replacement therapy (ert) for patients with type 1 gaucher disease. none. risk summary available data on use of velaglucerase alfa in pregnant women includes more than 300 pregnancies reported from the pharmacovigilance database and published observational cohort studies, including the international gaucher disease registry. while available data cannot definitively establish or exclude the absence of a velaglucerase alfa associated risk during pregnancy, these data have not identified an association with use of velaglucerase alfa during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies no fetal harm was observed in rats or rabbits when velaglucerase alfa was administered intravenously during organogenesis at doses with exposures up to 1.8 times and 4.3 times, respectively, the recommended human daily dose (see data) . the estimated background risk of major birth defects and miscarriage for the indicate

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

takeda pharmaceuticals australia pty ltd - velaglucerase alfa, quantity: 400 u - injection, powder for - excipient ingredients: citric acid monohydrate; sucrose; polysorbate 20; sodium citrate dihydrate - vpriv is indicated for long-term enzyme replacement therapy (ert) for paediatric and adult patients with type 1 gaucher disease.

Israel - English - Ministry of Health

takeda israel ltd - velaglucerase alfa - lyophilized powder for solution for infusion - velaglucerase alfa 400 u/vial - velaglucerase alfa - velaglucerase alfa - vpriv is a hydrolytic glucocerebroside – specific enzyme indicated for the long term replacement therapy (ert) for pediatric and adult patients with type 1 gaucher disease.

European Union - English - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - velaglucerase alfa - gaucher disease - other alimentary tract and metabolism products, - vpriv is indicated for long-term enzyme-replacement therapy (ert) in patients with type-1 gaucher disease.

Canada - English - Health Canada

takeda canada inc - velaglucerase alfa - powder for solution - 400unit - velaglucerase alfa 400unit - enzymes

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

shire pharmaceuticals ltd - velaglucerase alfa - powder for solution for infusion - 400unit

New Zealand - English - Medsafe (Medicines Safety Authority)

takeda new zealand limited - velaglucerase alfa 400 u;   - powder for infusion concentrate - 400 u - active: velaglucerase alfa 400 u   excipient: citric acid monohydrate polysorbate 20 sodium citrate dihydrate sucrose - vpriv is indicated for long-term enzyme replacement therapy (ert) for paediatric and adult patients with type i gaucher disease.

Singapore - English - HSA (Health Sciences Authority)

takeda pharmaceuticals (asia pacific) pte. ltd. - velaglucerase alfa - injection, powder, lyophilized, for solution - velaglucerase alfa 10 mg/vial

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

shire australia pty ltd - velaglucerase alfa -

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

shire pharmaceutical ireland ltd, ireland - velaglucerase alfa - powder for solution for infusion - 400 u