July 1, 2019

The European Committee for Medicinal Products for Human Use Backs Generic Lacosamide UCB for Partial-Onset Seizures

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for the antiepileptic lacosamide UCB (UCB Pharma SA) for partial-onset seizures.

This was an informed consent application, which makes use of data from the dossier of a previously authorized medicine. The reference product for lacosamide UCB is Vimpat (UCB).

“Lacosamide UCB is indicated as monotherapy and adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalization in adults, adolescents and children from 4 years of age with epilepsy,” the EMA said in a statement.

Lacosamide UCB will be available as a 10-mg/mL solution for infusion, a 10-mg/mL syrup, and film-coated tablets in strengths of 50 mg, 100 mg, 150 mg, and 200 mg. The most common side effects are dizziness, headache, diplopia, and nausea.

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