Canada - English - Health Canada

sanofi genzyme, a division of sanofi-aventis canada inc - agalsidase beta - powder for solution - 5mg - agalsidase beta 5mg - enzymes

Canada - English - Health Canada

sanofi genzyme, a division of sanofi-aventis canada inc - agalsidase beta - powder for solution - 35mg - agalsidase beta 35mg - enzymes

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

genzyme therapeutics ltd - agalsidase beta - powder for solution for infusion - 5mg

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

genzyme therapeutics ltd - agalsidase beta - powder for solution for infusion - 35mg

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

takeda pharmaceuticals australia pty ltd - agalsidase alfa, quantity: 1 mg/ml - injection, concentrated - excipient ingredients: polysorbate 20; water for injections; sodium hydroxide; sodium chloride; monobasic sodium phosphate monohydrate - replagal (agalsidase alpha ghu) is indicated for long-term enzyme replacement therapy of patients with fabry disease (alpha-galactosidase a deficiency).

European Union - English - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - agalsidase alfa - fabry disease - other alimentary tract and metabolism products, - replagal is indicated for long-term enzyme-replacement therapy in patients with a confirmed diagnosis of fabry disease (α-galactosidase-a deficiency).

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - agalsidase beta 35mg (- rch, plus 2mg overage);   - powder for infusion - 35 mg - active: agalsidase beta 35mg (- rch, plus 2mg overage)   excipient: dibasic sodium phosphate dodecahydrate mannitol monobasic sodium phosphate dihydrate nitrogen

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - agalsidase beta 5.5mg (- rch, includes 0.5 mg overage);   - powder for infusion concentrate - 5 mg - active: agalsidase beta 5.5mg (- rch, includes 0.5 mg overage)   excipient: dibasic sodium phosphate dodecahydrate mannitol monobasic sodium phosphate dihydrate nitrogen

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

shire pharmaceuticals ltd - agalsidase alfa - solution for infusion - 1mg/1ml

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

shire pharmaceuticals ltd - agalsidase alfa - solution for infusion - 1mg/1ml