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 February 2021

The following CAPs has been added to the list:

The following CAPs has been removed from the list:

  • Udenyca - Withdrawal of marketing authorisation
  • Idelvion - Five years following its authorisation (June 2016)
  • EndolucinBeta - Five years following its authorisation (July 2016)
  • Neparvis - Five years following its authorisation (June 2016)
  • Galafold - Five years following its authorisation (June 2016)
  • Alprolix - Five years following its authorisation (May 2016)

The following NAPs has been added to the list:

  • Efluelda - New biological

For the UK, as from 1st January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI, therefore, several annexes (Annex III -List of intravenous iron-containing medicinal products in the EU, Annex V - List of hydroxyethyl starch(HES)-containing medicinal products in the European Union, Annex VII – List of teicoplanin-containing medicinal products in the EU, Annex XII - List of dexamfetamine sulphate-containing medicinal products in the EU, Annex XIII - List of Valproate and related substances, Annex XIV - List of Retinoid-containing medicinal products and related substances) were amended. The United Kingdom was changed to North Ireland (United Kingdom) where applicable.

List of medicines under additional monitoring

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