PV Bulletin

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

MHRA issued a Class 4 defect notification for Ponlimsi (Denosumab) 60mg solution for injection, requiring healthcare professionals to check stock for affected batches.

Primary source: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-notification-teva-uk-ltd-ponlimsi-denosumab-60mg-solution-for-injection-in-pre-filled-syringe-el-26-a-slash-27

PV Impact Brief

MonitoringConfidence: high

What changed

MHRA issued a Class 4 medicines defect notification for Ponlimsi (Denosumab) 60mg solution for injection (Teva UK Ltd).

Why it matters

Class 4 defect notifications indicate a potential quality issue that does not pose a serious risk to patient safety but requires action to ensure product integrity and correct usage.

Action needed

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

Relevant for
Regulatory Intelligence LeadSignal Management Lead
Processes impacted
Signal ManagementLabeling
Owner

Regulatory Intelligence Lead

Review cadence

Immediate review and action; monitor for updates from MHRA.

Regulatory action details

Action type
Medicines recall/notification
Publication date
2026-06-04
Safety issue
Labelling error on the carton (states 'For application to the skin' instead of 'subcutaneous use'). The product itself is correct and intended for subcutaneous injection.

Affected products

  • Ponlimsi (Denosumab) 60mg Solution for Injection
    Teva UK Ltd
    184472186711188656

PV internal implications

HCPs should note the labeling error. Ensure correct administration (subcutaneous). Report any adverse reactions via Yellow Card.

View regulator source

Evidence and confidence

Confidence: highSource updated: Jun 4, 2026

Full briefing

Practical implication

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

The MHRA published a Class 4 medicines defect notification for Teva UK Ltd's Ponlimsi (Denosumab) 60mg solution for injection in pre-filled syringes. Healthcare professionals should check their stock for affected batches and follow instructions in the notice.

What changed: MHRA issued a Class 4 medicines defect notification for Ponlimsi (Denosumab) 60mg solution for injection (Teva UK Ltd).

Why it matters: Class 4 defect notifications indicate a potential quality issue that does not pose a serious risk to patient safety but requires action to ensure product integrity and correct usage.

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

View original source

Published from the Firecrawl agent regulatory extraction pipeline.

#MHRA#Safety Signals#firecrawl-agent#regulatory-extraction#Other#Class 4 Medicines Defect Notification

Related updates for your role

publicFDA · USA · Updated Sep 4, 2026

FDA Grants Accelerated Approval to Etcamah for Advanced Breast Cancer

Urgency: High

Regulatory teams must prepare for updating labeling to include details on the new indication and required diagnostic methods, along with planning for the confirmatory studies mandated by the FDA.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicMHRA · UK · Updated Sep 4, 2026

Change to the definition of regulated activity with children from 1 September 2026

Urgency: High

Organizations must re-evaluate roles related to children's activities and prepare to request Enhanced DBS checks including access to the Children’s Barred List check starting from 1 September 2026.

Country ComplianceRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicUK Health Security Agency · UK · Updated Sep 7, 2026

Low Flu Vaccination Rates Among Primary School Children

Urgency: High

Parents are reminded to complete and return flu vaccination consent forms promptly as vaccination sessions in schools are set to start this week, aiming for completion by late November.

Signal ManagementPV Quality Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: PV Quality Lead, Medical Safety Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicANSM (France) · France · Updated Sep 7, 2026Translated From French

Recall of Gore Viabahn Endoprosthesis with Bioactive Heparin Coating

Urgency: High

Health establishments receiving affected devices must be notified, and protocols established to ensure compliance with the recall.

Signal ManagementQPPV
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: QPPV, Medical Safety Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward