The marketing authorization holder has informed its supplied customers in a letter dated July 25, 2017, that a test result within the scope of a stability study showed a reduced active ingredient content. Therefore, the batch 559CG placed on the market in Austria, which is related to this stability study, is recalled from the market.
|Name of the medicinal product||Edronax 4 mg -Tabletten|
|Marketing authorisation number(s)||1-22230|
|Marketing authorisation holder||Pfizer Corporation Austria GmbH|
|Classification of the recall||2|
|BASG reference number||INS - 640.001 - 2197|