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Class 4 Medicines Defect Notification

publicMedicines and Healthcare products Regulatory Agency (MHRA) · United Kingdom · Updated Jun 4, 2026

Class 4 Medicines Defect Notification: Teva UK Ltd, Ponlimsi (Denosumab) 60mg Solution for Injection in Pre-filled Syringe

Check stock for the affected batches of Ponlimsi (Denosumab) 60mg solution for injection and follow the instructions in the MHRA notice.

Signal ManagementLabelingRegulatory Intelligence Lead

SOP Impact2 SOPs

Relevant for: Regulatory Intelligence Lead, Signal Management Lead

verifiedRegulatory action: Medicines recall/notification

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Tag: Class 4 Medicines Defect Notification | PV Bulletin