Brivaracetam Sol. Inf 10mg/ml (5ml Vial) (EU CTD Available: Q3 2022)

Product description

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: Q3 2022)
Stability Studies: Zone II / Zone IVb
Shelf life (Originator): Four (4) years
Batch Sizes: 5,555 vials
Pack Sizes: To be defined / Originator pack: BT x 10 vials.
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Specifications

Categories Finished Dosage FormsInjectables; Pharmaceutical Products / ATC codingNervous System; Finished Dosage FormsOut-licensing
Sales markets Middle East Region (e.g. UAE); Oceania; North America (USA, Canada); Africa; Central America (e.g. Mexico); Europe - EU countries; Europe - non EU (e.g. UK, Russia, ex-CIS countries); South America (e.g. Brazil, Colombia); South East Asia (e.g. Thailand, Philippines, Singapore)
Supplied from Greece

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Brivaracetam Sol. Inf 10mg/ml (5ml Vial) (EU CTD Available: Q3 2022)

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