ANFARM HELLAS S.A. sell "Lacosamide Solution for Infusion 10mg/ml (EU CTD Available: Q2 2021)"

A 10 mg/ml lacosamide solution for infusion referencing Vimpat (UCB). Lacosamide is a functionalized amino acid within the antiepileptic class; in vitro electrophysiology studies show it selectively enhances slow inactivation of voltage-gated sodium channels, stabilizing hyperexcitable neuronal membranes. It is used as monotherapy and adjunctive therapy for partial-onset seizures with or without secondary generalization in adults, adolescents, and children from age 4 with epilepsy. Dossier status: ongoing, with EU CTD available Q2 2021. Stability studies cover Zone II/Zone IVb, with a three-year originator shelf life. Batch size is 7,766 vials, packed in boxes of 1 or 5 vials.