Other safety alerts
|
| |
| European Union: EMA alerts EU patients and healthcare professionals to reports of falsified Ozempic pens |
| |
European Medicines Agency (EMA) announces that pre-filled pens falsely labelled as the diabetes medicine Ozempic (semaglutide, 1 mg, solution for injection) have been identified at wholesalers in the European Union (EU) and the United Kingdom.
The pens, with labels in German, originated from wholesalers in Austria and Germany. The pens have batch numbers, 2D barcodes and unique serial numbers from genuine Ozempic packs. In the EU, each medicine pack has a unique 2D barcode and serial number so that it can be tracked in an EU-wide electronic system. When the packs of the falsified Ozempic were scanned, the serial numbers were shown to be inactive, thereby alerting operators to a potential falsification. There are differences in the appearance between the falsified pen and the original pen. A picture of the falsified pen has been published by the German medicines agency.
There is no evidence that any falsified pens have been dispensed to patients from legal pharmacies and there are no reports of harm to patients in relation to the falsified medicine.
The issue is currently being investigated by EU medicines regulatory authorities and the police. EMA is assisting national authorities in their investigations. Wholesalers and pharmacies in the impacted countries have been warned about the suspicious offers of Ozempic to wholesalers. In addition, parallel distributors across the EU have been alerted. EMA is monitoring the situation closely and will provide updates as appropriate.
The latest reports of falsification come in the wake of an increase in demand for Ozempic which has also led to a shortage situation.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/ema-alerts-eu-patients-healthcare-professionals-reports-falsified-ozempic-pens
In Hong Kong, Ozempic Solution For Injection In 3.0ml Pre-filled Pen 1mg/dose (HK-66487) is a pharmaceutical product registered by Novo Nordisk Hong Kong Ltd. The product is a prescription-only medicine. The packaging of the falsified Ozempic pens mentioned in the above EMA’s announcement is different from the registered packaging of the product in Hong Kong.
Ends/Thursday, Oct 19, 2023
Issued at HKT 14:00
|
| |
|
