List of medicines under additional monitoring

The list of medicines under additional monitoring includes medicines authorised in the European Union (EU) that are being monitored particularly closely by regulatory authorities. Medicines under additional monitoring have a black inverted triangle displayed in their package leaflet and summary of product characteristics, together with a short sentence explaining what the triangle means.

The list includes centrally and nationally authorised medicines in the following categories:

Update - Summary of changes in November 2023

The following CAPs have been added to the list:

The following CAPs have been removed from the list:

  • NexoBrid - PASS completed
  • Alofisel - Five years following its authorisation (April 2018)
  • Ritemvia - Withdrawal of marketing authorisation
  • Idacio - Five years following its authorisation (April 2019)
  • Rizmoic - Five years following its authorisation (February 2019)
  • Ninlaro - Switch to non-conditional Marketing Authorisation
  • Zirabev - Five years following its authorisation (February 2019)
  • Tremelimumab AstraZeneca - Withdrawal of marketing authorisation
  • AJOVY - Five years following its authorisation (April 2019)
  • Pelmeg - Five years following its authorisation (December 2018)

List of medicines under additional monitoring

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