Regulatory intelligence & pharmacovigilance updates, mapped to your role.

Regulatory Intelligence teams must monitor updates regarding the ongoing CHMP evaluation and potential implications for existing marketing authorizations.

Update all internal and external communications, labels, and marketing materials to reflect the new product name, Svariya, instead of Rivaroxaban Koanaa.

Initiate the update of labeling materials for Rasonque to reflect the new FDA approval and ensure compliance with reporting requirements for newly approved therapies.

Healthcare professionals must include daraxonrasib in adverse event reporting as the new treatment option is now available for eligible patients.

Affected healthcare facilities should remove all Automated Impella Controllers from use and stock, ensure annual preventive maintenance is followed, and report any adverse reactions to Abiomed or MedWatch.

Facilities using these devices must immediately cease their use, segregate them from other stock, and return them to Boston Scientific. Relevant personnel must be notified of this recall.

Organisations should review their DBS checking arrangements, especially prioritizing checks that include the Children's Barred List for those working with children, as part of their compliance with the new definition from September 2026.

Submit bluetongue samples to APHA with forms attached securely on the outside of the parcel to facilitate rapid booking into their digital sample handling system.