"Koanaa Healthcare GmbH" has informed its customers in a letter dated August 10, 2017, that the further marketing of "Melphalan Koanaa 50 mg i.v. Powder and Solvent for Solution for Injection or Solution for Infusion" will be stopped and a recall will be carried out.On the part of the Federal Office for Safety in Health Care (BASG), there is an urgent suspicion of drug counterfeiting within the meaning of Section 1 (25) 2 of the Austrian Medicines Act, as amended. 1, as the above-mentioned medicinal product was marketed by the company "Koanaa Healthcare GmbH" with an apparently Austrian presentation and instructions for use, but does not have a valid marketing authorization in Austria.For the sake of completeness, it is also noted that the BASG, as the competent authority, has not issued an import permit for the medicinal product in question pursuant to the Austrian Medicinal Products Import Act, as amended.
|Name of the medicinal product||Melphalan Koanaa 50 mg i.v. Pulver und Lösungsmittel zur Herstellung einer Injektionslösung oder Infusionslösung|
|Marketing authorisation number(s)||keine|
|Marketing authorisation holder||Inverkehrbringer: Koanaa Healthcare GmbH|
|Batch number(s)||Alle Chargen|
|Classification of the recall||1|
|BASG reference number||INS-640.001-2218|