VIMPAT Solution for infusion Ref.[8019] Active ingredients: Lacosamide

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: UCB Pharma S.A., Allée de la Recherche 60, B-1070, Bruxelles, Belgium

Product name and form

Vimpat 10 mg/ml solution for infusion.

Pharmaceutical Form

Solution for infusion.

Clear, colourless solution.

Qualitative and quantitative composition

Each ml of solution for infusion contains 10 mg lacosamide. Each vial of 20 ml solution for infusion contains 200 mg lacosamide.

Excipients with known effect: Each ml of solution for infusion contains 2.99 mg sodium.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Lacosamide

Lacosamide is a functionalised amino acid. The precise mechanism by which lacosamide exerts its antiepileptic effect in humans remains to be fully elucidated.

List of Excipients

Water for injections
Sodium chloride
Hydrochloric acid (for pH adjustment)

Pack sizes and marketing

Colourless type I glass vial with a chlorobutyl rubber closure coated with a fluoropolymer. Packs of 1x20 ml and 5x20 ml.

Not all pack sizes may be marketed.

Marketing authorization holder

UCB Pharma S.A., Allée de la Recherche 60, B-1070, Bruxelles, Belgium

Marketing authorization dates and numbers

EU/1/08/470/016-017

Date of first authorisation: 29 August 2008
Date of latest renewal: 31 July 2013

Drugs

Drug Countries
VIMPAT Austria, Australia, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, United Kingdom, United States

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