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 (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 June 2026

The following CAPs have been added to the list: 

• Adstiladrin – New active substance, new biological and Conditional marketing authorisation
• Imdylltra - New active substance and new biological
• Bysumlog – New biological
• Joenja – New active substance, Authorised under exceptional circumstances
• Zepzelca – New active substance

The following CAPs have been removed from the list:

• Retsevmo - Five years following its authorisation (July 2021), switch to non-conditional marketing authorisation
• Qoyvolma - Withdrawal of marketing authorisation

The following NAPs have been added to the list:

• Grassmuno 6000 SU/ml, 2700 SU/ml, 900 SU/ml – New biological
• Esche Prick Test RX – New biological
• Olivenbaum Prick Test RX  – New biological
• Platane Prick Test RX – New biological
• Glaskraut Prick Test RX – New biological
• Brennessel Prick Test RX – New biological
• Ragweed Prick Test RX – New biological
• Spitzwegerich Prick Test RX – New biological
• Hund Prick Test RX – New biological
• Pferd Prick Test RX – New biological
• Alternaria alternata Prick Test RX – New biological
• Latex Prick Test RX – New biological
• Garnele Prick Test RX – New biological
• Kabeljau Prick Test RX – New biological
• Thunfisch Prick Test RX – New biological
• Meerschweinchen Prick Test RX – New biological

The following NAPs have been removed from the list:

• None

List of medicines under additional monitoring

List of medicinal products under additional monitoring

Reference Number: EMA/245297/2013 Rev. 145

List of medicinal products under additional monitoring

Reference Number: EMA/245297/2013 Rev. 145

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