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 January 2019:

The following CAPs have been added to the list up to 25th January 2019:

  • Dengvaxia (Dengue tetravalent vaccine (live, attenuated)) - New active substance, new biological.
  • Flucelvax Tetra (Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)) - New biological.
  • Ogivri (Trastuzumab) - New biological.
  • Macimorelin Aeterna Zentaris (Macimorelin) - New active substance.
  • Erleada (Apalutamide) - New active substance.

The following CAPs have been removed from the list until 25th January 2019:

  • Cyltezo (Adalimumab) - marketing authorisations have been withdrawn and products are therefore taken off the additional monitoring list.
  • Adempas (riociguat), Entyvio (Vedolizumab) and Vokanamet (Canagliflozin/metformin hydrochloride) - five years after the Union Reference Date (EURD), Adempas, Entyvio and Vokanamet are no longer under additional monitoring and therefore removed from this list.
  • PASS finalised for Corlentor (Ivabradine), Procoralan (Ivabradine) and Ivabradine Anpharm (Ivabradine) and therefore removed from this list.

In addition, annex XIII - List of Valproate and related substances (sodium valproate, valproic acid, valproate semisodium, valpromide-containing medicinal products) in the European Union has been updated.

 

List of medicines under additional monitoring

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