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13 Apr 2021

Pipeline - Brivaracetam Oral Solution Product Profile

Brivaracetam 10mg/ml Oral Solution
Reference Product: Briviact® / UCB

Description: Brivaracetam is an antiepileptic agent which is indicated as adjunctive therapy in the treatment of partial onset seizures with or without secondary generalization in adults, adolescents and children from 4 years of age with epilepsy.
Dossier Status: On-going (EU CTD Available: Q4 2022)
Stability Studies: Zone II / Zone IVb
Shelf life (Originator): Four (4) years
Batch Size: To be defined
Pack Sizes: To be defined / Originator pack: BT x 1 Glass Bottle.

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