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 October 2020

The following CAPs has been added to the list:

The following CAPs has been removed from the list:

  • Spectrila - Five years following its authorisation (January 2016), this product no longer qualifies for additional monitoring as a new active substance and therefore is removed from this list.
  • Vaxelis - Five years following its authorisation (January 2016), this product no longer qualifies for additional monitoring as a new active substance and therefore is removed from this list.
  • Lenalidomide Accord - additional monitoring status due to an optional scope criteria no longer required.
  • Kovaltry - Five years following its authorisation (March 2016), this product no longer qualifies for additional monitoring as a new active substance and therefore is removed from this list.
  • Episalvan - Five years following its authorisation (January 2016), this product no longer qualifies for additional monitoring as a new active substance and therefore is removed from this list.
  • Vepacel - Withdrawal of marketing authorisation.
  • Briviact - Five years following its authorisation (January 2016), this product no longer qualifies for additional monitoring as a new   active substance and therefore is removed from this list.

The following NAPs has been removed from the list:

  • FibClot - Five years following its authorisation (July 2016), this product no longer qualifies for additional monitoring as a new active substance and therefore is removed from this list.
  • Panzyga - Five years following its authorisation (July 2016), this product no longer qualifies for additional monitoring as a new active substance and therefore is removed from this list.

List of medicines under additional monitoring

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