Teva Reports Labelling Error for Ponlimsi (Denosumab) 60mg Injection
Teva UK Limited has identified a labelling error on the Ponlimsi (Denosumab) carton, incorrectly stating 'For application to the skin'.
Asset
Ponlimsi (Denosumab)
Indication
Oncology / Bone Metabolism
Status
Under Review
Signal Score
8.2
Signal assessment
Signal strength
high
Confidence level
moderate
Why it matters
The labelling error on Ponlimsi could lead to significant patient safety concerns and damage Teva's reputation. Monitoring regulatory responses and corrective actions is crucial to mitigate risks and maintain trust in the product.
Recommended action
Humanexa recommends Monitor.
Analysis
Follow-up on regulatory responses and any corrective actions taken by Teva, as well as potential impacts on sales.
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