Israel - engelsk - 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

USA - engelsk - 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 - engelsk - 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.

Israel - hebraisk - Ministry of Health

pfizer pharmaceuticals israel ltd - taliglucerase alfa - אבקה להכנת תמיסה לאינפוזיה - 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 with a confirmed diagnosis of type 1 gaucher disease.

New Zealand - engelsk - 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 - fransk - Health Canada

pfizer canada ulc - taliglucérase alfa - poudre pour solution - 200unité - taliglucérase alfa 200unité - enzymes

Canada - engelsk - Health Canada

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

Taiwan - kinesisk - 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

輝瑞大藥廠股份有限公司 台北市信義區松仁路100號42、43樓 (37199708) - taliglucerase alfa - 凍晶注射劑 - taliglucerase alfa (9200082800) u (unit) - taliglucerase alfa - 改善高雪氏症症狀，包括貧血、血小板減少症、肝臟或脾臟腫大、骨病變，但對於神經學症狀無效。

Singapore - engelsk - HSA (Health Sciences Authority)

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

Chile - spansk - ISPC (Instituto de Salud Pública de Chile)

pfizer chile s.a. - taliglucerasa alfa - sin formulas