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 June 2016 (updated)
The following products have been added to the list:
- Aitaro (standardised allergen extract from house dust mites): New biological;
- Darzalex (daratumumab): New active substance, conditional authorisation;
- Flixabi (infliximab): New biological;
- Galafold (migalastat): New active substance;
- Idelvion (albutrepenonacog alfa): New active substance;
- Neparvis (sacubitril / valsartan): New active substance;
- Odefsey (emtricitabine / rilpivirine / tenofovir alafenamide): New active substance;
- Pandemic influenza vaccine H5N1 MedImmune (pandemic influenza vaccine (H5N1) (live attenuated, nasal)): New active substance, conditional authorisation;
- Penthrox (methoxyflurane): PASS;
- Strimvelis (autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence): New active substance, PASS;
- Uptravi (selexipag): New active substance;
- Zevtera 500 mg powder for concentrate for solution for infusion (ceftobiprole medocaril sodium): New active substance.
The following products have been removed from the list:
- Champix (varenicline): The previously imposed PASS (study A3051123) has been completed and, therefore, this medicinal product is no longer under additional monitoring.
- Victrelis (boceprevir): Five years following its authorisation, this product is no longer considered a new active substance. It is thus removed from the additional monitoring list.
- Zytiga (abiraterone): Following the renewal of the marketing authorisation, this product is no longer considered a new active substance. It is thus removed from the additional monitoring list.
A medicine can be included on this list when it is approved for the first time or at any time during its life-cycle.
Medicines containing new active substances or new biologicals remain on the list for five years. Medicines authorised under exceptional circumstances and those with PASSs remain on the list until the conditions have been fulfilled.
In addition to these medicines, medicines can be included on the list at the request of the European Commission or a medicines regulatory authority in an EU Member State after consulting the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC).
More information on additional monitoring is available:
- Guideline on good pharmacovigilance practices: Module X - Additional monitoring
- Medicines under additional monitoring: Background information
Contents of the list
For each medicine, the list shows:
- the invented name;
- the active substance;
- the reason why the medicine is on the list;
- the marketing-authorisation holder;
- a link to the European public assessment report (for centrally authorised medicines).
The Agency published the first version of the list in April 2013. It is updated every month following review by the PRAC.
Updating product information
Marketing-authorisation holders of medicines on the list are required to update the product information to include the new black symbol and explanatory text using the latest version of the product-information template.
Companies responsible for medicines on the list started to include new information in the product information in mid-2013:
- For new medicines on the list that had an opinion from the Committee for Medicinal Products for Human Use (CHMP) in or after June 2013, marketing-authorisation applicants must use the latest version of the template including the black triangle.
- For medicines that were already authorised, marketing-authorisation holders had to use the latest version of the template at the next regulatory procedure affecting the product-information template. If there were no such procedures in 2013, companies were required to submit a type-IAIN variation no later than 31 December 2013.
Full details on the implementation are available in these documents:
- Implementation plan for the introduction of the new pharmacovigilance legislation requirements into the product information of centrally approved medicinal products
- Commission implementing regulation (EU) No 198/2013 of 7 March 2013 on the selection of a symbol for the purpose of identifying medicinal products for human use that are subject to additional monitoring