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 October 2019: 

The following CAPs have been added to the list up to 20th September 2019:

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

  • Nuceiva (botulinum toxin type A) – New biological
  • Trogarzo (ibalizumab) – New active substance, new biological
  • Vitrakvi (larotrectinib) – Conditional authorisation, new active substance

The following CAPs have been removed from the list up to 25 October 2019:

  • Cyramza (ramucirumab) - Five years following its authorisation, Cyramza no longer qualifies for additional monitoring as a new active substance and therefore is removed from this list.
  • Daklinza (daclatasvir) - The marketing authorisation for Daklinza has expired following the marketing-authorisation holder’s decision not to pursue the renewal of the marketing authorisation.
  • Lynparza (olaparib) - Five years following its authorisation, Lynparza no longer qualifies for additional monitoring as a new active substance and therefore is removed from this list.
  • Moventig (Naloxegol) - Five years following its authorisation, Moventig no longer qualifies for additional monitoring as a new active substance and therefore is removed from this list.
  • Ofev (nintedanib) - Five years following its authorisation, Ofev no longer qualifies for additional monitoring as a new active substance and therefore is removed from this list.
  • Xadago (Safinamide) - Five years following its authorisation, Xadago no longer qualifies for additional monitoring as a new active substance and therefore is removed from this list.

The following CAP has withdrawn from the market and therefore from the additional
monitoring list:

  • Zalmoxis (allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (ΔLNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2))

In addition, annex X List of domperidone containing medicinal products in the European Union has been removed.

List of medicines under additional monitoring

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