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

biomarin pharmaceutical inc. - cerliponase alfa (unii: x8r2d92qp1) (cerliponase alfa - unii:x8r2d92qp1) - cerliponase alfa 150 mg in 5 ml - brineura is indicated to slow the loss of ambulation in symptomatic pediatric patients 3 years of age and older with late infantile neuronal ceroid lipofuscinosis type 2 (cln2), also known as tripeptidyl peptidase 1 (tpp1) deficiency. brineura is contraindicated in patients with: - any sign or symptom of acute, unresolved localized infection on or around the device insertion site (e.g. cellulitis or abscess); or suspected or confirmed cns infection (e.g. cloudy csf or positive csf gram stain, or meningitis) [see warnings and precautions (5.1)] . - any acute intraventricular access device-related complication (e.g., leakage, extravasation of fluid, or device failure) [see warnings and precautions (5.2)] . - ventriculoperitoneal shunts. risk summary there are no available data on brineura use in pregnant women to inform a drug-associated risk of pregnancy-related outcomes. animal reproduction studies have not been conducted using cerliponase alfa. the estimated background risk of major birth defects and miscarr

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 - 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.

European Union - English - EMA (European Medicines Agency)

biomarin international limited - cerliponase alfa - neuronal ceroid-lipofuscinoses - other alimentary tract and metabolism products, - brineura is indicated for the treatment of neuronal ceroid lipofuscinosis type 2 (cln2) disease, also known as tripeptidyl peptidase 1 (tpp1) deficiency,

Canada - English - Health Canada

biomarin international limited - cerliponase alfa - solution - 150mg - cerliponase alfa 150mg - enzymes

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

biomarin europe ltd - cerliponase alfa - solution for infusion - 30mg/1ml