ANFARM HELLAS S.A. sell "Lacosamide Oral Solution 10mg/ml (EU CTD Available: Q2 2022)"
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Product Name
Lacosamide Oral Solution 10mg/ml (EU CTD Available: Q2 2022)
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Specifications
- Dosage Form: Oral solution, 10 mg/ml (reference product: Vimpat)
- Indication: Antiepileptic functionalised amino acid used as monotherapy and adjunctive therapy for partial-onset seizures with or without secondary generalisation, in adults, adolescents and children from 4 years of age
- Storage Conditions: Store below 30°C in the original container
- Packaging: Oral solution bottle with dosing syringe/cup; EU CTD dossier available
Other Information
Additional Description:
A 10 mg/ml lacosamide oral solution referencing Vimpat (UCB). Lacosamide is a functionalized amino acid within the antiepileptic drug class, 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 2022. Stability studies cover Zone II/Zone IVb, with a three-year originator shelf life. Batch size is 970 bottles, packed one glass bottle per box.
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