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Medicinal products under additional monitoring

Medicinal products under additional monitoring

A black inverted triangle in a package leaflet and summary or product characteristics means that the medicine is under additional monitoring. The European Union (EU) has introduced a new way of identifying medicines that are being monitored particularly closely by pharmaceutical regulatory authorities.

Additional monitoring is required when there is less information available about the medicine compared with other medicines, for example because it is new on the market or there is limited data on its long-term use.

Fimea urges health care professionals and patients to report any suspected adverse reactions, especially when caused by medicines under additional monitoring.

Read more about medicinal products under additional monitoring and adverse drug reactions:

Adverse drug reactions

Report of a suspected adverse effectes associated with a drug/vaccine

European Medicines Agency’s (EMA) list of medicinal products under additional monitoring

European Medicines Agency’s (EMA) brochure about the black triangle

European Medicines Agency’s (EMA) video about the black triangle