2. Black triangle drugs

Medicines that are being monitored particularly closely by regulatory authorities in the European Union (EU) are described as being under 'additional monitoring'.  Such products are labelled with an inverted black triangle

A Black Triangle is always assigned to a medicine if:

  • it contains a new active substance; new medicines or vaccines authorised on or after January 2011 are assigned a Black Triangle
  • it is a biological medicine, such as a vaccine or a medicine derived from plasma (blood);
  • 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.

Healthcare professionals are encouraged to report all suspected adverse drug reactions regardless of the severity of the reaction.

Click here for further information and a list of the drugs under close surveillance

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