MHRA (UK)Original article
Class 4 Medicines Defect Notification: Teva UK Ltd, Ponlimsi (Denosumab) 60mg Solution for Injection in Pre-filled Syringe, EL(26)A/27
RegulatoryPonlimsiNegative
AI Analysis
Summary
Teva UK Limited reported a Class 4 medicines defect notification for Ponlimsi (Denosumab) 60mg due to incorrect labelling on the carton indicating 'For application to the skin' instead of the correct licensed route of subcutaneous administration.
Outcome Details
Class 4 labelling error notification - carton incorrectly states 'For application to the skin' when product is licensed for subcutaneous use
Importance:3/10
Sentiment:
-0.60
labelling errorregulatory notificationproduct qualityUK MHRADenosumab
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Published by MHRA (UK) on June 4, 2026 10:00 AM