Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: UCB Pharma S.A., Allée de la Recherche 60, B-1070, Bruxelles, Belgium
Vimpat 10 mg/ml syrup.
| Pharmaceutical Form |
|---|
|
Syrup. A slightly viscous clear, colourless to yellow-brown liquid. |
Each ml of syrup contains 10 mg lacosamide. 1 bottle of 200 ml contains 2,000 mg lacosamide.
Excipients with known effect: Each ml of Vimpat syrup contains 187 mg sorbitol (E420), 2.60 mg sodium methyl parahydroxybenzoate (E219), 2.14 mg propylene glycol (E1520), 1.42 mg sodium and 0.032 mg aspartame (E951).
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 |
|---|
|
Glycerol (E422) |
A 200 ml amber glass bottle with white polypropylene screw cap, a 30 ml measuring cup and a 10 ml oral syringe (black graduation marks) with an adaptor.
One full 30 ml measuring cup corresponds to 300 mg of lacosamide. The minimum volume is 5 ml which corresponds to 50 mg of lacosamide. As from the 5 ml graduation mark, each graduation mark corresponds to 5 ml which is 50 mg of lacosamide (for example 2 graduation marks correspond to 100 mg).
One full 10 ml oral syringe corresponds to 100 mg of lacosamide. The minimum extractable volume is 1 ml which corresponds to10 mg of lacosamide. As from the 1 ml graduation mark, each graduation mark corresponds to 0.25 ml which is 2.5 mg of lacosamide.
UCB Pharma S.A., Allée de la Recherche 60, B-1070, Bruxelles, Belgium
EU/1/08/470/018
Date of first authorisation: 29 August 2008
Date of latest renewal: 31 July 2013
| 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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