Inverted black triangle

The European Union introduced a new procedure for marking medicinal products that are under special supervision by the pharmaceutical regulatory authorities. Such medicines are said to be under additional monitoring. Additional monitoring is used for medicines on which there is less information available than usual due to their novelty or limited long-term use.

These medicines are marked with an inverted black triangle in the package leaflet and summary of product characteristics. Health care professionals and patients are encouraged to actively report any suspected adverse reactions to the medicines under additional monitoring.