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 December 2019: 

The following CAP has been added to the list up to 5 December 2019:

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

List of medicines under additional monitoring

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