Brivaracetam Oral Solution 10mg/ml (EU CTD Available: Q4 2022)
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: 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.
|Categories||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)|
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