New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - imiglucerase 212 u (biological product from recombinant cho cells) - powder for infusion - 40 u/ml - active: imiglucerase 212 u (biological product from recombinant cho cells) excipient: citric acid monohydrate mannitol nitrogen polysorbate 80 sodium citrate dihydrate

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

genzyme corporation - imiglucerase (unii: q6u6j48bwy) (imiglucerase - unii:q6u6j48bwy) - imiglucerase 40 u in 1 ml - cerezyme is indicated for treatment of adults and pediatric patients 2 years of age and older with type 1 gaucher disease that results in one or more of the following conditions: - anemia - thrombocytopenia - bone disease - hepatomegaly or splenomegaly none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to cerezyme during pregnancy. pregnant women exposed to cerezyme and health care providers are encouraged to contact the gaucher patient registry at 1-800-745-4447, extension 15500 or visit www.registrynxt.com. risk summary available data on more than 500 pregnancies from the international gaucher disease registry, postmarketing reports, published observational studies and case reports with cerezyme or non–us-licensed imiglucerase use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. there are risks associated with symptomatic type i gaucher disease

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

sanofi-aventis australia pty ltd - imiglucerase, quantity: 10 ml (equivalent: imiglucerase, qty 400 u) - injection, powder for - excipient ingredients: citric acid monohydrate; nitrogen; polysorbate 80; sodium citrate dihydrate; mannitol - cerezyme (imiglucerase) is indicated for long-term enzyme replacement therapy for patients with a confirmed diagnosis of non-neuronopathic (type 1) or chronic neuronopathic (type 3) gaucher disease who exhibit clinically significant non-neurological manifestations of the disease. the non-neurological manifestations of gaucher disease include one or more of the following conditions: a) anaemia; - b) thrombocytopenia; - c) bone disease; - d) hepatomegaly or splenomegaly.

Singapore - English - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - imiglucerase - injection, powder, for solution - 424 u - imiglucerase 424 u

European Union - English - EMA (European Medicines Agency)

sanofi b.v. - imiglucerase - gaucher disease - other alimentary tract and metabolism products, - cerezyme (imiglucerase) is indicated for use as longterm enzyme replacement therapy in patients with a confirmed diagnosis of non-neuronopathic (type 1) or chronic neuronopathic (type 3) gaucher disease who exhibit clinically significant nonneurological manifestations of the disease. the non-neurological manifestations of gaucher disease include one or more of the following conditions:anaemia after exclusion of other causes, such as iron deficiencythrombocytopeniabone disease after exclusion of other causes such as vitamin d deficiencyhepatomegaly or splenomegaly

Israel - English - Ministry of Health

sanofi israel ltd - imiglucerase - powder for concentrate for solution for infusion - imiglucerase 400 u/vial - imiglucerase - imiglucerase - for the long term enzyme replacement therapy for patients with a confirmed diagnosis of type 1 gaucher disease that results in one or more of the following conditions: - anemia - thrombocytopenia - bone disease - hepatomegaly or splenomegaly.

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - imiglucerase 400 u (per 10 ml -biological product from recombinant cho cells);   - powder for infusion - 40 u/ml - active: imiglucerase 400 u (per 10 ml -biological product from recombinant cho cells)   excipient: citric acid monohydrate mannitol nitrogen polysorbate 80 sodium citrate dihydrate - cerezyme is indicated for long - term enzyme replacement therapy for patients with a confirmed diagnosis of non-neuronopathic (type 1) or chronic neuronopathic (type 3) gaucher disease who exhibit clinically significant non-neurological manifestations of the disease. the non-neurological manifestations of gaucher disease include one or more of the following conditions: a) anaemia; b) thrombocytopenia; c) bone disease; d) hepatomegaly or splenomegaly.

Canada - English - Health Canada

sanofi genzyme, a division of sanofi-aventis canada inc - imiglucerase - powder for solution - 200unit - imiglucerase 200unit - enzymes

Canada - English - Health Canada

sanofi genzyme, a division of sanofi-aventis canada inc - imiglucerase - powder for solution - 400unit - imiglucerase 400unit - enzymes

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

genzyme therapeutics ltd - imiglucerase - powder for solution for infusion - 400unit