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 January 2020: 

The following CAPs have been added to the list up to 24 January 2020:

The following CAPs have been removed from the list up to 24 January 2020:

  • Akynzeo (netupitant/palonosetron) - Five years following its authorisation, Akynzeo no longer qualifies for additional monitoring as a new active substance and therefore is removed from this list.
  • Gardasil 9 (human papillomavirus 9-valent vaccine [recombinant, adsorbed]) - Five years following its authorisation, Gardasil 9 no longer qualifies for additional monitoring as a new active substance and therefore is removed from this list.
  • Kengrexal (cangrelor) - Five years following its authorisation, Kengrexal no longer qualifies for additional monitoring as a new active substance and therefore is removed from this list.
  • Orbactiv (oritavancin) - Five years following its authorisation, Orbactiv no longer qualifies for additional monitoring as a new active substance and therefore is removed from this list.
  • Saxenda (liraglutide) - Five years following its authorisation, Saxenda no longer qualifies for additional monitoring as a new biological and therefore is removed from this list.
  • Sivextro (tedizolid phosphate) - Five years following its authorisation, Sivextro no longer qualifies for additional monitoring as a new biological and therefore is removed from this list.
  • Xydalba (dalbavancin) - Five years following its authorisation, Xydalba no longer qualifies for additional monitoring as a new active substance and therefore is removed from this list.

The following CAP has been withdrawn from the market and therefore from the additional monitoring list:

  • Kromeya (adalimumab)

In addition, Annex V (List of hydroxyethyl starch-containing medicinal products in the EU) has been updated.

List of medicines under additional monitoring

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