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Black triangle - drugs under additional monitoring

The European Union (EU) has introduced a new procedure for the product information of medicines that supervisory authorities are monitoring extra closely. The package insert for these medicines states that they are subject to 'additional monitoring'.


The package insert and the product information for medical professionals, the so-called "summary of product characteristics", of medicines subject to this additional monitoring contain a black inverted equilateral triangle with a short sentence indicating what the triangle means: this medicine is subject to additional monitoring.


The black triangle will be used in all EU member states to identify medicines under this additional surveillance. The symbol will appear on the relevant package leaflets from autumn 2013. It will not appear on the outer packaging or label of medicines.


Patients and medical professionals are strongly advised to report all suspected adverse drug reactions with a black triangle so that new information that becomes available can be analyzed in a targeted manner.

For more information on the black triangle, please refer to the website of the Medicines Evaluation Board (CBG):


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