Recall | Medicines | 15/09/2011

The marketing authorization holder, in agreement with the European Medicines Agency (EMA), has informed its supplied customers by fax dated September 14 that all batches of Vimpat Syrup are being recalled. The reason for this recall is precipitation of the active ingredient observed in some batches of the syrup.

Note: Please also refer to the Institute Pharmacovigilance safety information dated July 22, 2011 regarding Vimpat (lacosamide).

Name of the medicinal product Vimpat 15 mg/ml Sirup
Marketing authorisation number(s) EU/1/08/470/014-015
Marketing authorisation holder UCB S.A., BE

Durchführung Rückruf:
UCB Pharma GmbH, AT
Batch number(s) Alle
Expiry date 09/04/2019
Classification of the recall2
BASG reference number INS-640.001-0186

Further inquiry note