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:

• 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.

Update - Summary of changes in April 2023

The following CAPs have been added to the list:

• Pombiliti - New active substance, new biological
• SOTYKTU – New active substance
• BIMERVAX - New active substance, new biological
• BEKEMV – New biological

The following CAPs have been removed from the list:

• Senshio - PASS completed
• Onpattro - Five years following its authorisation (September 2018)
• Inpremzia - Withdrawal of marketing authorisation
• Xerava - Five years following its authorisation (October 2018)
• Cablivi - Five years following its authorisation (September 2018)
• HyQvia – PASS completed

In addition following annexes were updated:

• Annex XIV (list-retinoid-containing-medicinal-products-related-substances-acitretin-alitretinoin) – comments received from Portugal and Czech Republic
• Annex IX - List of combined hormonal contraceptives containing chlormadinone in the European Union - comments received from Czech Republic
• Annex V - List of hydroxyethyl starch(HES)-containing medicinal products in the European Union - comments received from Czech Republic
• Annex XIII - List of Valproate and related substances (sodium valproate, valproic acid, valproate semisodium, valpromide-containing medicinal products) in the European Union - comments received from Czech Republic

• European public assessment reports (EPARs) for medicines under additional monitoring (opens in new window)
• Background information: Medicines under additional monitoring
• Product-information templates
• European Commission: The EU pharmacovigilance system