The distribution company has informed its supplied customers in a letter dated 21.07.2016 that in the instructions for use of this batch the wrong daily maximum dose of ten capsules is indicated. The correct maximum is five capsules per day. This medicinal product is placed on the market in Austria within the scope of a transfer notification pursuant to the Austrian Medicinal Products Import Act 2010.
|Name of the medicinal product||Thromboreductin 1,0 mg Kapseln|
|Marketing authorisation number(s)||Nicht bekannt, im Ausland zugelassene Arzneispezialität|
|Marketing authorisation holder||AOP Orphan Pharmaceuticals AG|
|Classification of the recall||2|
|BASG reference number||INS - 640.001 - 1785|