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 March 2020: 

The following CAPs have been added to the list up to 20 March 2020:

The following NAP has been withdrawn from the list:

  • Sonazoid (perflurobutan) - Five years following its authorisation (July 2014), Sonazoid no longer qualifies for additional monitoring as a new active substance and therefore is removed from this list.

In addition, Annex IV (List of thiocolchicoside-containing medicinal products in the EU) has been removed (the PASS has been finalised).

List of medicines under additional monitoring

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