The competent national authorities have notified the European Medicines Agency (EMA) that they have been identified prefilled pens falsely labeled as medication for diabetes Ozempic (semaglutide, 1 mg, solution for injection) at wholesalers in the EU and UK. The pens with German labels came from wholesalers in Austria and Germany.
The original Ozempic pens have lot numbers, 2D barcodes and unique serial numbers corresponding to each package. In the EU, each package of medicines has a unique 2D barcode and serial number so that it can be tracked in an electronic system throughout the EU. When the scanning of the counterfeits was carried out, discovered that the serial numbers were inactivethus alerting operators to possible counterfeiting.
There are differences in appearance between the counterfeit pen and the original pen. The German medicines agency has published an image of the counterfeit pen (note that the image of the counterfeit pen is an example and there are probably counterfeit pens with other characteristics as well).
There is no evidence that counterfeit pens have been dispensed to patients in legal pharmacies and no reports of harm to patients in relation to counterfeit medicine.
The matter is being under study currently for the EU medicines regulatory authorities and police. The EMA is assisting national authorities in their investigations. Wholesalers and pharmacies in affected countries have been warned about suspicious offers of Ozempic to wholesalers. In addition, parallel distributors throughout the EU have been alerted.