NeLM news service
European CHMP recommends approval of lacosamide (Vimpat) syrup to replace recalled syrup

Source: European Medicines Agency (EMA)

Date published: 16/12/2011 17:35

Summary
by: Yuet Wan

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of lacosamide (Vimpat) 10-mg/ml syrup of the anti-epilepsy medicine Vimpat to replace the 15-mg/ml syrup recalled earlier in the year. The recall of the 15-mg/ml syrup began in September 2011 after the marketing-authorisation holder found uneven distribution of the active substance in some bottles, putting patients at risk of inaccurate dosing. This was caused by the active substance forming a precipitate during storage. 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.

Preview your comment

Add new comment

Comment text:

Comments

There are no comments yet. You could be the first! You must be Logged In to comment.