The PRAC maintains a list of medicines under additional monitoring in the EU, which it updates every month. For more information, see the list of medicines under additional monitoring.
Additional monitoring status may be assigned to a medicine when it is approved for the first time or at any time during its life cycle. A medicine remains under additional monitoring for 5 years or until the PRAC decides to remove it from the list.
There may be a delay between the Agency's decision to add or remove a medicine from this list and the time when the updated package leaflet comes into circulation. This is because it takes some time for the updated package leaflet to be printed and to gradually substitute older versions already on the market.
In case of any uncertainty, always check the list on the Agency’s website, which is reviewed every month and is constantly up-to-date.