The UK Medicines and Healthcare products Regulatory Agency has issued a Class 4 medicines defect notification for Ponlimsi denosumab 60mg injection following identification of incorrect labelling on product cartons. Teva UK Limited reported that outer carton packaging incorrectly states “for application to the skin,” despite the medication being licensed exclusively for subcutaneous injection.
The defect is classified as Class 4—the lowest risk category in the MHRA’s medicines defect system—as the critical safety information remains accurate on both the vial and pre-filled syringe labels themselves. Denosumab is a monoclonal antibody treatment for osteoporosis and skeletal-related complications in cancer patients, requiring subcutaneous administration by trained healthcare professionals or instructed patients.
The MHRA has confirmed that the product remains safe for continued use. Healthcare providers and patients should verify injection instructions on the vial and syringe labels, which contain the correct administration route.
Read the full article on GMJ Newsroom.
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