Pipeline - Brivaracetam Product Profile

18 Sep 2020

Brivaracetam 10mg/ml (5ml Vial) Solution for Injection/Infusion
Reference Product: Briviact® / UCB

Description: Brivaracetam is an antiepileptic agent which is indicated as adjunctive therapy in the treatment of partial onsetseizures with or without secondary generalization in adults, adolescents and children from 4 years of age with epilepsy.
Dossier Status: On-going (EU CTD Available: 2022)
Stability Studies: Zone II / Zone IVb
Shelf life (Originator): Four (4) years
Batch Sizes: To be defined
Pack Sizes: To be defined / Originator pack: BT x 10 vials.