The list includes centrally and nationally authorised medicines in the following categories: Medicines under additional monitoring have a black inverted triangle displayed in their package leaflet and summary of product characteristics, together with a short sentence explaining what the triangle means.
The list of medicines under additional monitoring includes medicines authorised in the European Union (EU) that are being monitored particularly closely by regulatory authorities. List of medicines under additional monitoring Submitting a post-authorisation application.Post-authorisation efficacy studies (PAES).List of medicines under additional monitoring.Direct healthcare professional communications.
Changing the labelling and package leaflet (Article 61(3) notifications).Changing the (invented) name of a medicinal product.
