Guidelines on labelling of medicinal products included on the list of medicines under additional monitoring in the EU
A number of medicinal products must have a black triangle () displayed in the summary of product characteristics and the package leaflet together with an explanation and an encouragement to report side effects. The list includes new medicinal products and medicinal products that the EU authorities want to obtain information about quickly, for example new safety information. It does not mean that the medicinal products are unsafe to use.
Information in the summary of product characteristics:
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Doctors and healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.
Information in the package leaflet:
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
A medicine becomes subject to additional monitoring in the following cases:
- it contains a new active substance authorised in the EU after 1 January 2011,
- it is a biological medicine, such as a vaccine or a medicine derived from plasma (blood), for which there is limited post-marketing experience,
- it has been given a conditional approval (where the company that markets the medicine must provide more data about it) or approved under exceptional circumstances (where there are specific reasons why the company cannot provide a comprehensive set of data),
- the company that markets the medicine is required to carry out additional studies, for instance, to provide more data on long-term use of the medicine or on a rare side effect seen during clinical trials.
Other medicines can also be placed under additional monitoring, based on a decision by the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC)
More information: Medicines under additional monitoring