Since 2013, medicinal products that are under additional monitoring are labelled with a black triangle in all EU Member States. As a rule, a medicinal product is under additional monitoring if there is less information about it as compared with other medicinal products. Reasons for this could be that the medicinal product is new on the market or that there are only limited data on its long-term use. The black triangle indicates that this medicine is being monitored particularly closely as compared to other medicinal products. However, it does not mean that the medicinal product is not safe.
The black inverted triangle is to be displayed in the package leaflet and the summary of product characteristics (the so-called "Fachinformation"). However, it will not appear on the outer packaging or labelling of a medicine.
For further information please go to the page "Medicinal Products under Additional Monitoring"
For a list of medicinal products labelled with the black triangle please click here: List of Medicinal Products with Black Triangle