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 May 2019:

The following CAPs have been added to the list up to 24th May 2019:

The following non-CAPs have been added to the list up to 24th May 2019: 

  • Trivalent Influenza Vaccine (Influenza vaccine (split virion, inactivated)) - new biological.  

The following CAPs have been removed from the list up to 24th May 2019: 

  • Nuwiq (Simoctocog alfa) and Tivicay (Dolutegravir) - Five years following its authorisation, Nuwiq and Tivicay are no longer qualified for additional monitoring as a new active substance and therefore removed from this list.

The following non-CAPs have been removed from the list up to 24th May 2019: 

  • Apleek (Ethinyl estradiol/gestodene) - Withdrawal of marketing authorisation and therefore removed from this list.

In addition, annex XIII List of Valproate and related substances in the European Union, annex III List of intravenous iron-containing medicinal products in the European Union and annex XIV List of Retinoid-containing medicinal products and related substances in the European Union has been updated. 

List of medicines under additional monitoring

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