Parenteral iron-containing medicinal products - referral
Monitor for changes in labeling requirements and risk management strategies as a result of the ongoing review by PRAC.
Primary source: Website data protection notice
The establishment of a new EU supply chain that is anticipated to resolve the critical shortage of Visudyne by 2027.
The end of the shortage will significantly impact the availability of Visudyne, aiding in better safety management and access to necessary medical treatment for patients.
Monitor the supply chain developments and prepare to adjust inventory management practices as the end of the shortage approaches.
Regulatory Intelligence Lead
Review in the next regulatory intelligence cycle.
Monitor the supply chain developments and prepare to adjust inventory management practices as the end of the shortage approaches.
The European Medicines Agency has announced that a critical shortage of Visudyne, an eye medicine, is expected to be resolved by 2027 due to the establishment of a new supply chain.
What changed: The establishment of a new EU supply chain that is anticipated to resolve the critical shortage of Visudyne by 2027.
Why it matters: The end of the shortage will significantly impact the availability of Visudyne, aiding in better safety management and access to necessary medical treatment for patients.
Practical implication: Monitor the supply chain developments and prepare to adjust inventory management practices as the end of the shortage approaches.
Published from the regulator source ingestion pipeline after PV impact triage.
Monitor for changes in labeling requirements and risk management strategies as a result of the ongoing review by PRAC.
Signal management teams need to prepare for potential updates in labeling, usage guidelines, and monitoring requirements for injectable iron-containing medicines.
Regulatory compliance workflows involving the Dengue Tetravalent Vaccine outside the EU need to incorporate the EMA's positive opinion concerning its use in individuals aged 4 to 60.
Regulatory intelligence processes must update reporting timelines and workflows to incorporate the new PSUSA findings for exemestane.