Lacosamide Solution for Infusion 10mg/ml (EU CTD Available: Q2 2021)

Product description

Lacosamide 10mg/ml Solution for Infusion
Reference Product: Vimpat® / UCB Description: Lacosamide is a functionalised amino acid which belongs to the group of antiepileptics. In vitro electrophysiological studies have shown that lacosamide selectively enhances slow inactivation of voltage-gated sodium channels, resulting in stabilization of hyperexcitable neuronal membranes. Lacosamide is used as monotherapy and adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.
Dossier Status: On-going / EU CTD Available: Q2 2021
Stability Studies: Zone II / Zone IVb
Shelf life (Originator): Three (3) years
Batch Sizes: 7.766 vials
Pack Sizes: BT x 1 vial & BT x 5 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)

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Lacosamide Solution for Infusion 10mg/ml (EU CTD Available: Q2 2021)

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