News Category: Regulatory news
The HPRA confirms that pre-filled pens falsely labelled as the diabetes medicine Ozempic, which were the subject of a recent alert by the European Medicines Agency (EMA), have not been detected on the Irish market at this time.
The HPRA has been notified that falsified units from two batches of Ozempic product have been identified at wholesalers in the UK, Germany and Austria. According to the EMA, it is not aware that any falsified pens have been dispensed in Europe to patients from legitimate pharmacies and there are no reports of harm to patients in relation to this issue.
There is no evidence that this falsified product is on the Irish market. The HPRA continues to closely monitor the situation and is engaging with national partners across the medicines supply chain including the Pharmaceutical Society of Ireland (PSI) and the Irish Medicines Verification Organisation (IMVO). Relevant information has been circulated to wholesalers and pharmacists who have been asked to remain vigilant with regard to this matter.
The HPRA is also working closely with the EMA and other national regulators in the EU and UK with a continued focus on maintaining the security of the wider supply chain.
Further updates will be provided as necessary.