Pharmacovigilance

Recall of a Duodopa intestinal gel (20 mg/ml levodopa and 5 mg/ml carbidopa) lot

10.02.2010

Due to suspected quality defect, the Agency for Medicinal Products and Medical Devices on 9 February 2010 recalled one lot (no. 09J26G11) of the medicinal product Duodopa intestinal gel (20 mg/ml levodopa and 5 mg/ml carbidopa), manufactured by Solvay Pharmaceuticals GmbH, Germany.

Temporary marketing suspension of Reductil (sibutramine) in Croatia

22.01.2010

The European Medicines Agency (EMA) released a public statement on 21 January 2010, recommending the suspension from the European Union markets of the medicinal product Reductil, which contains sibutramine as the active substance, due to unfavourable benefit/risk ratio.

New information from the Agency for Medicinal Products and Medical Devices and the European Medicines Agency (EMA) on adverse reactions to the pandemic vaccine Focetria

19.01.2010

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