Panama - English - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

biomarin international limited - galsulfasa - galsulfasa....5 mg.

Israel - English - Ministry of Health

medison pharma ltd - cerliponase alfa - solution for infusion - cerliponase alfa 30 mg / 1 ml - cerliponase alfa - brineura is indicated for the treatment of patients with neuronal ceroid lipofuscinosis type 2 (cln2) disease, also known as tripeptidyl peptidase 1 (tpp1) deficiency.

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

biomarin pharmaceutical australia pty ltd - cerliponase alfa, quantity: 30 mg/ml - injection, solution - excipient ingredients: dibasic sodium phosphate heptahydrate; sodium chloride; potassium chloride; magnesium chloride hexahydrate; calcium chloride dihydrate; water for injections; monobasic sodium phosphate monohydrate - brineura is indicated for the treatment of neuronal ceroid lipofuscinosis type 2 (cln2) disease, also known as tripeptidyl peptidase 1 (tpp1) deficiency.

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.

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

biomarin pharmaceutical inc. - pegvaliase (unii: n6uah27euv) (pegvaliase - unii:n6uah27euv) - palynziq is indicated to reduce blood phenylalanine concentrations in adult patients with phenylketonuria (pku) who have uncontrolled blood phenylalanine concentrations greater than 600 micromol/l on existing management. none. risk summary based on findings in studies of pregnant animals without pku treated with pegvaliase-pqpz, palynziq may cause fetal harm when administered to a pregnant woman. limited available data with pegvaliase-pqpz use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. there are risks to the fetus associated with poorly controlled phenylalanine concentrations in women with pku during pregnancy including increased risk for miscarriage, major birth defects (including microcephaly, major cardiac malformations), intrauterine fetal growth retardation, and future intellectual disability with low iq; therefore, phenylalanine concentrations should be closely monitored in women with pku during pregnancy (see clinical considerations and data).

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

biomarin pharmaceutical australia pty ltd - galsulfase, quantity: 5 mg - injection, concentrated - excipient ingredients: monobasic sodium phosphate monohydrate; water for injections; dibasic sodium phosphate heptahydrate; polysorbate 80; sodium chloride - for the long-term enzyme replacement therapy in patients with mucopolysaccharidosis vi (mps vi - n acetylgalactosamine 4-sulfatase deficiency)

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).

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

biomarin pharmaceutical australia pty ltd - sapropterin dihydrochloride, quantity: 100 mg - tablet, soluble - excipient ingredients: sodium stearylfumarate; calcium hydrogen phosphate; mannitol; crospovidone; ascorbic acid; riboflavin - kuvan is indicated for the treatment of hyperphenylalaninemia (hpa) in sapropterin-responsive adult and paediatric patients with phenylketonuria (pku) or tetrahydrobiopterin (bh4) deficiency (see section 4.2 dose and method of administration for definition of sapropterin responsiveness)

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

biomarin pharmaceutical australia pty ltd - sapropterin dihydrochloride, quantity: 500 mg - powder, oral - excipient ingredients: mannitol; potassium citrate; sucralose; ascorbic acid - kuvan is indicated for the treatment of hyperphenylalaninemia (hpa) in sapropterin-responsive adult and paediatric patients with phenylketonuria (pku) or tetrahydrobiopterin (bh4) deficiency (see section 4.2 dose and method of administration for definition of sapropterin responsiveness)

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

biomarin pharmaceutical australia pty ltd - sapropterin dihydrochloride, quantity: 100 mg - powder, oral - excipient ingredients: mannitol; potassium citrate; sucralose; ascorbic acid - kuvan is indicated for the treatment of hyperphenylalaninemia (hpa) in sapropterin-responsive adult and paediatric patients with phenylketonuria (pku) or tetrahydrobiopterin (bh4) deficiency (see section 4.2 dose and method of administration for definition of sapropterin responsiveness)