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:

Summary of changes in February 2019:

The following CAPs have been added to the list up to 22nd February 2019:

The following NAPs have been added to the list up to 22nd February 2019:

  • Ledraxen (enoxaparin sodium) – New biological

The following CAPs have been removed from the list up to 22nd February 2019:

  • Erivedge (Vismodegib), Jardiance (Empagliflozin) and Mekinist (Trametinib) - five years after the Union Reference Date (EURD), Erivedge, Jardiance and Mekinist are no longer under additional monitoring and therefore removed from this list.
  • PASS finalised for Kalydeco (Ivacaftor) and therefore removed from this list.

In addition, annex X - List of Domperidone-containing medicinal products in the European Union has been updated.

List of medicines under additional monitoring

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