Shots:

• The approval is based on the principle of extrapolation of its efficacy data in adults also supported by pharmacokinetic and safety data in children. Additionally- the safety and tolerability data of Brivlera in children 4 years and older were similar to observed in adults
• The usage of Brivlera in pediatric and adolescent patients is supported by the placebo-controlled partial-onset seizure studies in adults- PK study in pediatric aged 4 to 17 years of and for the achievement of similar plasma concentrations as of adults weight-based dose adaptations were practiced
• Brivlera is an anti-epileptic drug (AED) displays a high and selective affinity for synaptic vesicle protein 2A (SV2A) developing anticonvulsant effects- approved by Health Canada as adjunctive therapy for partial-onset seizures in patients 4 years of age and older

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