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 November 2018:

The following CAPs have been added to the list up to 26 November 2018:

  • Enoxaparin Becat (also known in some EU countries as Losmina, Enoksaparin Rovi, Enoxaparina Rovi, Crusia and Arovi) - New biological
  • Emgality (Galcanezumab) – New active substance, new biological.
  • Hepaxane (Enoxaparin sodium)- New biological
  • Symkevi (tezacaftor/ivacaftor) - New active substance.  
  • Fulphila (pegfilgrastim) - New biological.

The following CAPs have been removed from the list until 26 November 2018:

  • Lusduna (Insulin glargine) and Eperzan (Albiglutide) - marketing authorisations have been withdrawn and products are therefore taken off the additional monitoring list.
  • Bemfola (Follitropin alfa), Elvanse (Lisdexamphetamine) and Latuda (Lurasidone) - five years after the Union Reference Date (EURD), Bemfola, Elvanse and Latuda are no longer under additional monitoring. They are therefore removed from this list.

In addition, annex I - Ethinylestradiol containing medicinal products in the European union and annex XIV - List of Retinoid-containing medicinal products and related substances (acitretin, adapalene, alitretinoin, bexarotene, isotretinoin, tazarotene and tretinoin) in the European Union has been updated.

List of medicines under additional monitoring

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