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

biomarin pharmaceutical inc. - elosulfase alfa (unii: odj69jzg85) (elosulfase alfa - unii:odj69jzg85) - elosulfase alfa 5 mg in 5 ml - vimizim (elosulfase alfa) is indicated for patients with mucopolysaccharidosis type iva (mps iva; morquio a syndrome). none pregnancy exposure registry there is a morquio a registry that collects data on pregnant women with mps iva who are treated with vimizim.  contact mars@bmrn.com or call 1-800-983-4587 for information and enrollment. risk summary available data from published case reports and postmarketing experience with vimizim use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies, no effects on embryo-fetal development were observed in rats given daily administration of elosulfase alfa up to 33 times the human steady-state auc (area under the concentration-time curve) at the recommended human weekly dose premating and through the period of organogenesis. no effects on embryo-fetal development were observed in rabbits given daily administration of elosulfase alfa at doses up

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

biomarin pharmaceutical australia pty ltd - elosulfase alfa, quantity: 1 mg/ml - injection, concentrated - excipient ingredients: arginine hydrochloride; monobasic sodium phosphate monohydrate; sodium acetate trihydrate; water for injections; polysorbate 20; sorbitol - vimizim is indicated for the treatment of mucopolysaccharidosis type iva (mps iva; morquio a syndrome).

Israel - English - Ministry of Health

medison pharma ltd - elosulfase alfa - concentrate for solution for infusion - elosulfase alfa 1 mg/ml - elosulfase alfa - vimizim is indicated for the treatment of mucopolysaccharidosis, type iva (morquio a syndrome ,mps iva) in patients of all ages.

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - elosulfase alfa 1 mg/ml;   - concentrate for injection - 1 mg/ml - active: elosulfase alfa 1 mg/ml   excipient: arginine hydrochloride monobasic sodium phosphate monohydrate polysorbate 20 sodium acetate trihydrate sorbitol water for injection - treatment of mucopolysaccharidosis type iva (mps iva; morquio a syndrome) in children and adults of all ages.

Canada - English - Health Canada

biomarin international limited - elosulfase alfa - solution - 1mg - elosulfase alfa 1mg - enzymes

European Union - English - EMA (European Medicines Agency)

biomarin international limited - recombinant human n-acetylgalactosamine-6-sulfatase - mucopolysaccharidosis iv - other alimentary tract and metabolism products, - vimizim is indicated for the treatment of mucopolysaccharidosis, type iva (morquio a syndrome, mps iva) in patients of all ages.

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

imported (united states - elosulfase alfa - solution for infusion - 1mg/1ml

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

biomarin europe ltd - elosulfase alfa - solution for infusion - 1mg/1ml

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

pharm-d sdn. bhd. - elosulfase alfa -

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

sambria pharmaceuticals, llc - lidocaine (unii: 98pi200987) (lidocaine - unii:98pi200987) - external anesthetic for temporary relief of pain and itching due to minor skin irritations.