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 April 2023

The following CAPs have been added to the list:

The following CAPs have been removed from the list:

  • Senshio - PASS completed
  • Onpattro - Five years following its authorisation (September 2018)
  • Inpremzia - Withdrawal of marketing authorisation
  • Xerava - Five years following its authorisation (October 2018)
  • Cablivi - Five years following its authorisation (September 2018)
  • HyQvia – PASS completed


In addition following annexes were updated:

  • Annex XIV (list-retinoid-containing-medicinal-products-related-substances-acitretin-alitretinoin) – comments received from Portugal and Czech Republic
  • Annex IX - List of combined hormonal contraceptives containing chlormadinone in the European Union - comments received from Czech Republic
  • Annex V - List of hydroxyethyl starch(HES)-containing medicinal products in the European Union - comments received from Czech Republic
  • Annex XIII - List of Valproate and related substances (sodium valproate, valproic acid, valproate semisodium, valpromide-containing medicinal products) in the European Union - comments received from Czech Republic

List of medicines under additional monitoring

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