Is Cerliponase alfa approved by the US FDA?

Drugs@FDA lists 1 application product line for Cerliponase alfa, including BRINEURA (Prescription).

Is Cerliponase alfa authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Cerliponase alfa: Brineura.

Are there safety signals or safety updates for Cerliponase alfa?

US FDA: 1 entry (latest 2024-07-24).

Active substance

Cerliponase alfa

US FDA 1
EMA 1
Health Canada 1
Safety 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
BRINEURA	30MG/ML	injectable · injection	BIOMARIN PHARM	Prescription	27 Apr 2017

EMA European Union — centrally authorised medicines

Brineura BioMarin International Limited · Authorised · authorised 30 May 2017 · ATC A16AB

Therapeutic indication (EMA)

Brineura is indicated for the treatment of neuronal ceroid lipofuscinosis type 2 (CLN2) disease, also known as tripeptidyl peptidase 1 (TPP1) deficiency

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
BRINEURA	02484013	150 MG / 5 ML	SOLUTION · INTRACEREBROVENTRICULAR	BIOMARIN INTERNATIONAL LIMITED

Safety signals and safety-related labeling changes

US FDA 24 Jul 2024 BRINEURA — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for cerliponase alfa →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.