Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - taliglucerase alfa - powder for solution for infusion - taliglucerase alfa 200 u/vial - taliglucerase alfa - taliglucerase alfa - elelyso™ (taliglucerase alfa) for injection is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for long-term enzyme replacement therapy (ert) for adults and pediatric patients with a confirmed diagnosis of type 1 gaucher disease

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

pfizer laboratories div pfizer inc - taliglucerase alfa (unii: 0r4nlx88o4) (taliglucerase alfa - unii:0r4nlx88o4) - taliglucerase alfa 200 u in 5 ml - elelyso is indicated for the treatment of patients 4 years of age and older with a confirmed diagnosis of type 1 gaucher disease. none. risk summary the limited available data on elelyso use in pregnant women are not sufficient to inform a drug-associated risk. however, there are clinical considerations [see clinical considerations] . in animal reproduction studies when pregnant rats and rabbits were administered taliglucerase alfa at intravenous doses up to 5 times the recommended human dose (rhd), there was no evidence of embryo-fetal toxicity [see data] . the estimated background risk of major birth defects and miscarriage for the indicated population(s) are 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 to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk women with type 1 gaucher disease have an increased risk of spontaneous abortion if diseas

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

pfizer australia pty ltd - taliglucerase alfa, quantity: 212 u - injection, powder for - excipient ingredients: mannitol; citric acid; sodium citrate dihydrate; polysorbate 80 - elelyso is indicated for long-term enzyme replacement therapy for adult and paediatric patients with a confirmed diagnosis of type 1 gaucher disease associated with at least one of the following: splenomegaly, hepatomegaly, anaemia, thrombocytopenia.

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - taliglucerase alfa 200 u (200 u deliverable, plus 6% overage) - powder for injection - 200 u - active: taliglucerase alfa 200 u (200 u deliverable, plus 6% overage) excipient: citric acid mannitol polysorbate 80 sodium citrate dihydrate - elelyso is indicated for long-term enzyme replacement therapy for adult and paediatric patients with a confirmed diagnosis of type 1 gaucher disease associated with at least one of the following: splenomegaly, hepatomegaly, anaemia, thrombocytopenia.

Canada - English - Health Canada

pfizer canada ulc - taliglucerase alfa - powder for solution - 200unit - taliglucerase alfa 200unit - enzymes

Singapore - English - HSA (Health Sciences Authority)

pfizer private limited - taliglucerase alfa - injection, powder, lyophilized, for solution - taliglucerase alfa 200units/vial

Canada - English - Health Canada

sanofi genzyme, a division of sanofi-aventis canada inc - eliglustat (eliglustat tartrate) - capsule - 84mg - eliglustat (eliglustat tartrate) 84mg - other miscellaneous therapeutic agents

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.

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