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

sanofi-aventis australia pty ltd - alglucosidase alfa, quantity: 52.5 mg - injection, powder for - excipient ingredients: monobasic sodium phosphate monohydrate; polysorbate 80; mannitol; nitrogen - myozyme (alglucosidase alfa-rch) is indicated for the long-term treatment of patients with a confirmed diagnosis of pompe disease (acid alfa-glucosidase deficiency).

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

genzyme corporation - alglucosidase alfa (unii: dti67o9503) (alglucosidase alfa - unii:dti67o9503) - alglucosidase alfa 5 mg in 1 ml - lumizyme® (alglucosidase alfa) [see description (11)] is a hydrolytic lysosomal glycogen-specific enzyme indicated for patients with pompe disease (acid α-glucosidase [gaa] deficiency). none. risk summary data from postmarketing reports and published case reports with alglucosidase alfa use in pregnant women have not identified a lumizyme-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. the continuation of treatment for pompe disease during pregnancy should be individualized to the pregnant woman. untreated pompe disease may result in worsening disease symptoms in pregnant women [see clinical considerations] . reproduction studies performed in mice and rabbits at doses resulting in exposures up to 0.4 or 0.5 times the human steady-state auc (area under the plasma concentration-time curve), respectively, during the period of organogenesis revealed no evidence of effects on embryo-fetal development. in mice there was an increase in pup mortality during lactation

Israel - English - Ministry of Health

sanofi israel ltd - alglucosidase alfa - powder for concentrate for infusion - alglucosidase alfa 50 mg/vial - alglucosidase alfa - alglucosidase alfa - myozyme is indicated for long-term enzyme replacement therapy (ert) in patients with a confirmed diagnosis of pompe disease (acid alpha-glucosidase deficiency). the benefits of myozyme in patients with late-onset pompe disease have not been established.

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

genzyme corporation - alglucosidase alfa (unii: dti67o9503) (alglucosidase alfa - unii:dti67o9503) - alglucosidase alfa 5 mg in 1 ml

Singapore - English - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - alglucosidase alfa - injection, powder, lyophilized, for solution - 52.5 mg - alglucosidase alfa 50 mg/vial

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

genzyme corporation - avalglucosidase alfa (unii: eo144cp0x9) (avalglucosidase alfa - unii:eo144cp0x9) - nexviazyme is indicated for the treatment of patients 1 year of age and older with late-onset pompe disease (lysosomal acid alpha-glucosidase [gaa] deficiency). none. risk summary available data from case reports of nexviazyme use in pregnant women are insufficient to evaluate for a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. however, available data from postmarketing reports and published case reports on alglucosidase alfa (another hydrolytic lysosomal glycogen-specific enzyme replacement therapy) use in pregnant women have not identified a drug-associated risk of adverse pregnancy outcomes. the continuation of treatment for pompe disease during pregnancy should be individualized to the pregnant woman. untreated pompe disease may result in worsening disease symptoms in pregnant women (see clinical considerations) . embryo-fetal toxicity studies performed in pregnant mice resulted in maternal toxicity related to an immunologic response (including an anaphyl

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

sanofi-aventis australia pty ltd - avalglucosidase alfa, quantity: 100 mg - injection, powder for - excipient ingredients: histidine; polysorbate 80; mannitol; histidine hydrochloride monohydrate; glycine - nexviazyme is indicated for long-term enzyme replacement therapy for the treatment of patients one year of age and older with pompe disease (acid ?-glucosidase deficiency).

European Union - English - EMA (European Medicines Agency)

sanofi b.v. - avalglucosidase alfa - glycogen storage disease type ii - other alimentary tract and metabolism products, - nexviadyme (avalglucosidase alfa) is indicated for long-term enzyme replacement therapy for the treatment of patients with pompe disease (acid α-glucosidase deficiency).

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

special order - alglucosidase alfa - infusion - 1.6mg/1ml

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

special order - alglucosidase alfa - infusion - 1.9mg/1ml