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:
- medicines that contain a new active substance that was not contained in any authorised medicine in the EU on 1 January 2011;
- biological medicines authorised after 1 January 2011 - this applies to all biological medicines including biosimilars;
- medicines for which the marketing-authorisation holder is required to carry out a post-authorisation safety study (PASS);
- medicines given conditional approval or authorised under exceptional circumstances and medicines authorised with specific obligations on the recording or monitoring of suspected adverse drug reactions.
Summary of changes in February 2024
The following CAPs have been added to the list:
- Omjjara – New active substance
- Skyclarys – New active substance
- Casgevy - New active substance, new biological and conditional marketing authorisation, PASS
- Velsipity – New active substance
The following CAPs have been removed from the list:
- Truvelog Mix - Withdrawal of marketing authorisation
- Rubraca - Five years following its authorisation (June 2018)
The following NAPs have been removed from the list:
- Retinoid-containing medicinal products and related substances (acitretin, alitretinoin and isotretinoin) - Various for full list see Annex XIV – PASS completed
List of medicines under additional monitoring
List of medicinal products under additional monitoring
List of medicinal products under additional monitoring
Annex I - List of cyproterone-acetate / ethinylestradiol-containing medicinal products in the European Union
Annex I - List of cyproterone-acetate / ethinylestradiol-containing medicinal products in the European Union
Annex V - List of hydroxyethyl starch (HES)-containing medicinal products in the European Union
Annex V - List of hydroxyethyl starch (HES)-containing medicinal products in the European Union
Annex IX - List of combined hormonal contraceptives containing chlormadinone in the European Union
Annex IX - List of combined hormonal contraceptives containing chlormadinone in the European Union
Annex XIII - List of Valproate and related substances in the European Union
Annex XIII - List of Valproate and related substances in the European Union