1 October 2013
The European Union has introduced a new way of identifying medicines that are being monitored particularly closely.
These medicines have a black inverted triangle displayed in their package leaflet, together with a short sentence that reads:
“This medicinal product is subject to additional monitoring”
All medicines are carefully monitored after they are placed on the EU market. However, medicines with the black triangle are being monitored even more closely than others.
This is generally because there is less information available about them compared with other medicines, for example because they are new on the market.
It does not mean that the medicine is unsafe.
How to report side effects
You should report any suspected side effects with a medicine you are taking, particularly if it displays the black triangle.
You can report side effects to your doctor, pharmacist or nurse. You can also report side effects directly to your national medicines regulator, using the
reporting system in your country. Information on how to do this can be found in the package leaflet of your medicine or on your national medicines regulator’s website. By reporting side effects, you can help medicines regulators assess whether the benefits of a medicine remain greater than its risks.
For additional information, please refer to EMA website with information materials available in different languages and format: https://www.ema.europa.eu/ema/index.jsp?curl=/pages/special_topics/general/general_content_000586.jsp
