Medicines marked with a black triangle ▼ are under additional monitoring to ensure that new information about their safety is communicated promptly and reliably. All suspected adverse reactions associated with the medicine must be reported to the Icelandic Medicines Agency (IMA).
Why are some medicines marked with a black triangle?
Certain medicines marketed in Iceland are under additional monitoring in Europe. This does not mean that they are more dangerous than other medicines, but medicines authorities consider it particularly important to obtain further information about their safety promptly.
This may, for example, be because they have only been in use for a short time and/or because better information is needed about certain adverse reactions that may be associated with their use.
Healthcare professionals are particularly encouraged to report adverse reactions caused by these medicines, but anyone can report adverse reactions to IMA.
A black triangle is used to identify medicines under additional monitoring in Europe, including in the Summary of Product Characteristics (SmPC) for healthcare professionals and in the package leaflet, which is included in the medicine’s packaging and intended for people using the medicine.
Service provider
Icelandic Medicines Agency