Implement the updated product information by November 5, 2026, ensuring that all labeling and documentation includes the new warnings and risk profiles.
Implement new labeling requirements for choline salicylate products by November 5, 2026, including specific warnings as outlined.
The marketing authorization holder must submit amended product information reflecting the new safety guidelines by October 9, 2026, with translations due by August 10, 2026.
Update labeling to reflect the new indication for Stelara, and ensure compliance with associated regulatory activities including safety monitoring.
Labeling and risk management updates are required to reflect the new drug approval, including the incorporation of safety and efficacy data from the VERIFY trial.
Customers are required to quarantine affected kits, complete response forms, and destroy the kits. Notification must also be sent to distributors who should inform their customers of these updated actions.
Health care professionals must complete and return the enclosed Reply Verification Tracking Form (RVTF) indicating the quantities of affected units to return, and monitor patients following the standard of care while discontinuing the use of these catheters.
Regulatory teams must update product labeling to reflect the new indication and assess signal management considerations for capivasertib.
