"AOP Orphan Pharmaceuticals AG" informed its supplied customers by letter dated August 31, 2017, that "Thromboreductin 1.0 mg Capsules" was placed on the market as a medicinal product not authorized in Austria in this strength with defective packaging, since the labeling and directions for use were not approved by the BASG.
|Name of the medicinal product||Thromboreductin 1,0 mg Kapseln|
|Marketing authorisation number(s)||keine|
|Marketing authorisation holder||Inverkehrbringer: AOP Orphan Pharmaceuticals AG|
|Classification of the recall||2|
|BASG reference number||INS-640.001-2234|