EMA Recommends Approval of Vimpat Syrup
Once approved by the European Commission, the 10-mg/ml syrup will provide a new treatment option that can be taken by mouth by patients who have difficulty swallowing tablets.
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of a 10-mg/ml syrup of the anti-epilepsy medicine Vimpat to replace the 15-mg/ml syrup recalled earlier in the year.
In assessing the application, the CHMP concluded that there is no risk of the active substance precipitating in the 10-mg/ml syrup, as long as it is not refrigerated. Once approved by the European Commission, the 10-mg/ml syrup will provide a new treatment option that can be taken by mouth by patients who have difficulty swallowing tablets.
The recall of the 15-mg/ml syrup from the European Union market began in September 2011 after the marketing-authorisation holder, UCB Pharma SA, found uneven distribution of the active substance, lacosamide, in some
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