The European Union has introduced a new way of identifying medicines that are being monitored particularly closely. These medicines have a black inverted triangle displayed in their package leaflet, together with a short sentence that reads: “This medicinal product is subject to additional monitoring.”
All medicines are carefully monitored after they are placed on the EU market. However, medicines with the black triangle are being monitored even more closely than others. This is generally because there is less information available about them compared with other medicines, for example because they are new on the market. It does not mean that the medicine is unsafe.
You can find more information at the link below. The video is available with the full audio track in English, Spanish, German, French and Italian, while the English version provides the option to switch on subtitles in all other EU languages. Please note that the factsheet is available in all official EU languages.