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Translated From French
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A referral procedure concerning parenteral iron-containing medicines has commenced, with a review focused on safety implications such as the risk of low blood phosphate levels.
This referral may lead to updates in labeling and necessary risk management actions for the affected products, impacting patient safety protocols.
Monitor for changes in labeling requirements and risk management strategies as a result of the ongoing review by PRAC.
Regulatory Intelligence Lead
Review in the next regulatory intelligence cycle.
Monitor for changes in labeling requirements and risk management strategies as a result of the ongoing review by PRAC.
The European Medicines Agency (EMA) has initiated a referral under Article 31 of Directive 2001/83/EC regarding parenteral iron-containing medicinal products, associated with low blood phosphate levels and bone issues.
What changed: A referral procedure concerning parenteral iron-containing medicines has commenced, with a review focused on safety implications such as the risk of low blood phosphate levels.
Why it matters: This referral may lead to updates in labeling and necessary risk management actions for the affected products, impacting patient safety protocols.
Practical implication: Monitor for changes in labeling requirements and risk management strategies as a result of the ongoing review by PRAC.
Published from the regulator source ingestion pipeline after PV impact triage.
Monitor the supply chain developments and prepare to adjust inventory management practices as the end of the shortage approaches.
Signal management teams need to prepare for potential updates in labeling, usage guidelines, and monitoring requirements for injectable iron-containing medicines.
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Regulatory intelligence processes must update reporting timelines and workflows to incorporate the new PSUSA findings for exemestane.
