Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: BioMarin International Limited, Shanbally, Ringaskiddy, County Cork, Ireland
Brineura 150 mg solution for infusion.
| Pharmaceutical Form |
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Solution for infusion. Clear to slightly opalescent and colourless to pale yellow solution, that may occasionally contain thin translucent fibres or opaque particles. |
Each vial of Brineura contains 150 mg of cerliponase alfa* in 5 ml of solution.
Each ml of solution for infusion contains 30 mg of cerliponase alfa.
* Cerliponase alfa is produced in mammalian Chinese Hamster Ovary cells.
Excipients with known effect: Each vial contains 17.4 mg of sodium in 5 ml of solution.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| 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. |
| List of Excipients |
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Brineura and flushing solution: Sodium phosphate dibasic heptahydrate |
Vial (type I glass) with a stopper (butyl rubber), a flip-off cap (polypropylene) and crimp seal (aluminium). Brineura has a green flip-off cap and flushing solution has a yellow flip-off cap.
Pack size of three vials: two 10 ml vials, each containing 150 mg of cerliponase alfa in 5 ml of solution; and one 10 ml vial, containing 5 ml flushing solution.
BioMarin International Limited, Shanbally, Ringaskiddy, County Cork, Ireland
EU/1/17/1192/001
Date of first authorisation: 30 May 2017
| Drug | Countries | |
|---|---|---|
| BRINEURA | Austria, Brazil, Canada, Estonia, Croatia, Ireland, Japan, Lithuania, Netherlands, Poland, Romania, United Kingdom |
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