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.

Updated on 29 October 2025:
'Summary of changes in October 2025' section

The list includes centrally and nationally authorised medicines (CAPs) 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 October 2025

The following CAPs have been added to the list:
•    Kisunla – new active substance, new biological and PASS
•    Romvimza – new active substance
•    Zurzuvae – new active substance
•    Winlevi – new active substance
•    Usrenty – new biological
 

The following CAPs have been removed from the list:
•    Imnovid (previously Pomalidomide Celgene) – PASS completed
•    Phesgo - five years following its authorisation (January 2021)
•    Ruxience - five years following its authorisation (April 2020)
•    Veklury - five years following its authorisation (July2020)
•    Heplisav B - five years following its authorisation (March 2021)
•    Inrebic - five years following its authorisation (February 2021)
•    Jinarc - PASS completed
•    Polivy - five years following its authorisation (January 2020)
 

The following NAPs have been added to the list:
None

The following NAPs have been removed from the list:
•    Medikinet 10 / 20 / 30 / 40 / 5 / 50 / 60 mg – PASS completed

List of medicines under additional monitoring

List of medicinal products under additional monitoring

Reference Number: EMA/245297/2013 Rev. 137

List of medicinal products under additional monitoring

Reference Number: EMA/245297/2013 Rev. 137

Annex V - List of hydroxyethyl starch (HES)-containing medicinal products in the European Union

Reference Number: EMA/48335/2014 corr. 7

Annex V - List of hydroxyethyl starch (HES)-containing medicinal products in the European Union

Reference Number: EMA/48335/2014 corr. 7

Annex XIII - List of Valproate and related substances in the European Union

Reference Number: EMA/11799/2015 Corr. 5

Annex XIII - List of Valproate and related substances in the European Union

Reference Number: EMA/11799/2015 Corr. 5

Annex XV - List of topiramate containing medicinal products in the European Union

Reference Number: EMA/227981/2024

Annex XV - List of topiramate containing medicinal products in the European Union

Reference Number: EMA/227981/2024

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