Reminder: This page provides global information for HCP or scientific research audience that may not be applicable in your country.
Locally approved resources can be found here.
So-called "routine" measures govern the proper use of the medicine: these are the information in the Summary of Product Characteristics for professionals and the package leaflet for patients, the packaging of the medicine or the introduction of prescription and dispensing conditions. When they appear insufficient to ensure safe and effective use, additional risk reduction measures (RRMs) may be implemented. MARRs are intended to prevent or reduce the likelihood of adverse reactions, their severity and/or impact on the patient.
XOSPATA™
As part of the Risk Management Plan for the Xospata specialty, and in agreement with the ANSM, Astellas provides the following additional risk reduction measures:
PADCEV™
As part of the Risk Management Plan for the Padcev specialty, and in agreement with the ANSM, Astellas provides the following additional risk reduction measure: