Product Details for: Brineura
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intraventricular
150MG/5ML (30MG/ML)
Single-Dose Vial
351(a)
Brineura
Rx
Proper Name
cerliponase alfa
cerliponase alfa
BLA Number
761052
761052
Applicant
BioMarin Pharmaceutical Inc.
BioMarin Pharmaceutical Inc.
Original Approval Date
April 27, 2017
April 27, 2017
Date of First Licensure