BRINEURA

This brand name is authorized in Austria, Brazil, Canada, Estonia, Ireland, Japan, Lithuania, Netherlands, Poland, Romania, United Kingdom

Active ingredients

The drug BRINEURA contains one active pharmaceutical ingredient (API):

1 Cerliponase alfa
UNII X8R2D92QP1 - CERLIPONASE ALFA

Cerliponase alfa is a recombinant form of human tripeptidyl peptidase-1 (rhTPP1). Cerliponase alfa is a proteolytic inactive proenzyme (zymogen) that is activated in the lysosome. The glycosylation profile of cerliponase alfa results in consistent cellular uptake and lysosomal targeting for activation.

Read about Cerliponase alfa

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
BRINEURA Solution for infusion European Medicines Agency (EU) MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code Group title Classification
A16AB17 A Alimentary tract and metabolism → A16 Other alimentary tract and metabolism products → A16A Other alimentary tract and metabolism products → A16AB Enzymes
Discover more medicines within A16AB17

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
Country: BR Câmara de Regulação do Mercado de Medicamentos Identifier(s): 542418120000201
Country: CA Health Products and Food Branch Identifier(s): 02484013
Country: EE Ravimiamet Identifier(s): 1746547
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 358138
Country: JP 医薬品医療機器総合機構 Identifier(s): 3959422A1028
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 1083032
Country: NL Z-Index G-Standaard, PRK Identifier(s): 148946
Country: PL Rejestru Produktów Leczniczych Identifier(s): 100396302
Country: RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale Identifier(s): W64486001

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