Medicines under additional monitoring
After being licensed and placed on the market, all medicines are carefully monitored. Some medicines are monitored even more intensively than normal. These medicines are said to be under additional monitoring.
Medicines under additional monitoring can be easily identified because they have an inverted black triangle symbol displayed in the package leaflet and in the information for healthcare professionals called the summary of product characteristics, together with a short sentence explaining what the triangle means:
▼ This medicinal product is subject to additional monitoring.
Medicines are placed under additional monitoring because there is less information available on it than on other medicines, for example because it is new to the market or there is limited data on its long-term use. It does not mean that the medicine is unsafe. Further information on what types of medicines are subject to additional monitoring is available on the EMA website and also from the Guideline on Good Pharmacovigilance Practices Module X – Additional Monitoring.
The black triangle is used in all EU Member States to identify medicines under additional monitoring. It started appearing in the package leaflets of the medicines concerned from the autumn of 2013. It will not appear on the outer packaging or labelling of medicines. The list of medicines subject to additional monitoring can be accessed from the EMA website.