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 July 2019: 

The following CAPs have been added to the list up to 26 
July 2019: 

The following CAPs have been removed from the list up 
to 26 July 2019: 

  • Imbruvica (Ibrutinib) - Five years following its authorisation, Imbruvica is no longer 
    qualified for additional monitoring as a new active substance and therefore 
    removed from this list.
  • Eurartesim (Dihydroartemisinin/piperaquine phosphate) - Eurartesim is removed from the 
    additional monitoring list as the condition(s) to the marketing authorisation 
    have been fulfilled.  

The following NAPs have been removed from the list up 
to 26th July 2019: 

  • Amitiza 24 microgram soft capsules (Lubiproston) - Marketing authorisation no longer valid and 
    therefor removed from the list
  • Zevtera 500 mg powder for concentrate for solution for infusion (also known in some EU 
    countries as Mabelio) (Ceftobiprole medocaril sodium) - Zevtera is removed from 
    the additional monitoring list as the condition(s) to the marketing 
    authorisation have been fulfilled 

In addition, annex VII List of Targocid and associated names in the European Union has been updated and a correction was made to the 
additional monitoring list by adding the product Luxturna (Voretigene neparvovec) which was authorised December 2018.

List of medicines under additional monitoring

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