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 March 2019:

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

  • Cutaquig (Human normal immunoglobulin) – New biological 

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

  • ATryn (Anti-thrombin alpha) – Withdrawal of marketing authorisation
  • Fluenz Tetra (Influenza vaccine (live attenuated, nasal) - Five years following its authorisation, this product is no longer qualified for additional monitoring as a new biological and therefore removed from this list. 

The following NAPs have been removed from the list up to 22nd March 2019:

  • Cluvot (Human plasma coagulation factor XIII)  - Five years following its authorisation, this product is no longer qualified for additional monitoring as a new biological and therefore removed from this list.

In addition, annex VII, annex III, annex IX, annex I, annex V, annex XIV and annex XIII –
have been updated.

List of medicines under additional monitoring

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