Recall "Melphalan Koanaa 50 mg i.v. Powder and solvent for solution for injection or solution for infusion" (active ingredient melphalan)
The medicinal product "Melphalan Koanaa 50 mg i.v. powder and solvent for the preparation of a solution for injection or infusion" (active substance Melphalan) does not have a valid marketing authorization in Austria, but was placed on the market by the company "Koanaa Healthcare GmbH", Fehrgasse 7, 2401 Fischamend, with an apparently Austrian presentation and instructions for use. Accordingly, there is an urgent suspicion of drug counterfeiting within the meaning of Section 1 (25) (2) of the Austrian Medicines Act (Arzneimittelgesetz idgF). For the sake of completeness, it should be noted that the BASG, as the competent authority, has not issued an import permit for the drug in question under the Austrian Medicines Import Act (Arzneiwareneinfuhrgesetz idgF).
Situation in Austria
In Austria, the following medicinal product is concerned: "Melphalan Koanaa 50 mg i.v. powder and solvent for the preparation of a solution for injection or infusion" (active substance Melphalan).
The BASG currently has no adverse reaction reports from Austria regarding the medicinal product "Melphalan Koanaa 50 mg i.v. Powder and solvent for solution for injection or solution for infusion".
Recommendations of the BASG
Recommendations for users, pharmacists:
- If you have obtained this medicinal product, you are requested to immediately report it to the Enforcement of the Institute Monitoring of the BASG/AGES Medical Market Surveillance (BASG/AGES) in accordance with Section 75q of the Austrian Medicines Act at enforcement@basg.gv.at.
- You are also requested to block the goods you have in stock and to report this to the Enforcement of the Institute for Surveillance of the BASG/AGES.
- If you have passed on packages of this drug to other customers, hospital wards, etc., inform them immediately and retrieve the goods from them.
- The packages of "Melphalan Koanaa 50 mg i.v. Powder and Solvent for Solution for Injection or Solution for Infusion" suspected of drug counterfeiting must not be used under any circumstances.
Additional Information:
Official message regarding the recall of Melphalan.
Queries:
Queries (technical):
Dr. Christoph Baumgärtel, Tel: +43 505 55-36004 Email: christoph.baumgaertel@ages.at
Queries (for media):
Communications Management, Tel.: +43 505 55-25000 E-mail: presse@ages.at
