MEDICINAL PRODUCTS UNDER ADDITIONAL MONITORING
All medicinal products in the market are carefully monitored and the regulatory authorities monitor some of them particularly closely. These medicinal products are described as medicinal products under “additional monitoring”.
Medicinal products under additional monitoring are labeled with a black inverted triangle in their summary of product characteristics and package leaflet together with the following sentence: This medicinal product is subject to additional monitoring.
The list includes medicinal products which have less information available, i.e. because they are new on the market. The medicinal product is not less safe because it is on the list. By reporting any adverse reaction, you can contribute to quick identification of new safety information.
The list of medicinal products under additional monitoring is published on the European Medicines Agency (EMA) website.
The list will be reviewed every month by the Pharmacovigilance Risk Assessment Committee (PRAC). For more information, see the press release on our website and EMA website.