BRIVIACT Solution for injection/infusion Ref.[116206] Active ingredients: Brivaracetam

Source: European Medicines Agency (EU)  Revision Year: 2025  Publisher: UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium

Product name and form

Briviact 10 mg/ml solution for injection/infusion.

Pharmaceutical Form

Solution for injection/infusion (injection/infusion).

Clear, colourless, solution.

Qualitative and quantitative composition

Each ml contains 10 mg brivaracetam.

Each 5 ml vial contains 50 mg brivaracetam.

Excipient(s) with known effect:

Each ml of solution for injection/infusion contains 3.8 mg sodium.

For the full list of excipients, see section 6.1.

Active Ingredient

Brivaracetam displays a high and selective affinity for synaptic vesicle protein 2A (SV2A), a transmembrane glycoprotein found at presynaptic level in neurons and in endocrine cells. Although the exact role of this protein remains to be elucidated it has been shown to modulate exocytosis of neurotransmitters.
List of Excipients

Sodium acetate (trihydrate)
Acetic acid, glacial (for pH-adjustment)
Sodium chloride
Water for injections

Pack sizes and marketing

6 ml nominal capacity glass vials (type I) with siliconized bromobutyl rubber stoppers and sealed with an aluminium/polypropylene tear off cap. Each single use vial contains an extractable volume of not less than 5 ml of solution for injection/infusion.

Each carton contains 10 vials.

Marketing authorization holder

UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium

Marketing authorization dates and numbers

EU/1/15/1073/022

Date of first authorisation: 14 January 2016
Date of latest renewal: 9 October 2020

Drugs

Drug Countries
BRIVIACT Austria, Australia, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Lithuania, Mexico, Netherlands, Poland, Romania, Turkey, United Kingdom, United States
 
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