Medicines under additional monitoring
The concept of additional monitoring and the black symbol were implemented in the pharmacovigilance legislation which entered into force in 2012.
A medicine can become subject to additional monitoring in connection with its approval or at any time during its life cycle.
If a medicine is under additional monitoring, a black inverted triangle is displayed in its summary of product characteristics and package leaflet with information to health professionals and patients.
The medicines that are subject to additional monitoring are published by the European Medicines Agency (EMA) on the list of medicines under additional monitoring.
The summaries of product characteristics of medicines authorised by the Danish Medicines Agency are available at produktresume.dk.
The summaries of product characteristics of centrally authorised medicines are available at the European Medicines Agency's website.
Under Medicines authorised with a summary of the risk management plan (sRMP), you can find the sRMPs authorised in connection with national, MRP and DCP procedures.The summaries of risk management plans (sRMPs) for centrally authorised medicines are available at the European Medicines Agency's website.