Update on EU Additional monitoring Medicines (January 2021)
Update on EU Additional monitoring Medicines (January 2021)
The list of medicinal products subject to additional monitoring includes medicinal products authorised in the European Union (EU) which are subject to particularly close regulatory oversight.
Medicines under additional monitoring have a black inverted triangle displayed in their package leaflet and in the information for healthcare professionals called the summary of product characteristics, together with a short sentence explaining what the triangle means:
This medicinal product is subject to additional monitoring.
The additional monitoring state is always applied to a drug when:
- It contains a new active substance which has been authorised in the European Union since 1 January 2011
- It is a biological medicine, such as a vaccine or a plasma (blood) derivative medicinal product, authorised in the European Union after 1 January 2011 and including biosimilars
- Conditional approved medicinal products (where the company commercializing the drug needs to provide more data) or approved under exceptional circumstances (where the company is unable to provide a complete dataset for specific reasons)
- medicinal products for which the marketing authorisation holder must carry out a post-authorisation safety study (PASS)
- it is authorised with specific requirements to record suspected adverse reactions
The up-to-date list of medicinal products under additional monitoring is available on the EMA website and is also published by the competent national authorities of the EU Member States.
The list is reviewed every month by the PRAC: List of medicines under additional monitoring
Update on EU Additional monitoring Medicines (January 2021)
In January 2021, there is an update on medicines under additional monitoring. The summary of changes as follows
The following centrally authorised products (CAPs) has been added to the list:
COMIRNATY (COVID-19 mRNA vaccine) – New active substance, New biological, Conditional marketing authorisation
COVID-19 Vaccine Moderna – New active substance and biological, Conditional marketing authorisation
FINTEPLA (fenfluramine) – PASS
LEQVIO (inclisiran) – New active substance
LIBMELDY (Autologous CD34+ cells encoding ARSA gene) – New active substance and biological, PASS
PHESGO (pertuzumab/trastuzumab) – New biological
TECARTUS (Brexucabtagene autoleucel) – New active substance and biological, Conditional marketing authorisation, PASS
VOCABRIA (cabotegravir) – New active substance and PASS
REKAMBYS (rilpivirine injection) – PASS
XOFLUZA (baloxavir marboxil) – New active substance
ROCLANDA (latanoprost/netarsudil) – New active substance
ELZONRIS (tagraxofusp-erzs) – New active substance and new biological, Authorised under exceptional circumstances
ONBEVZI (bevacizumab) – New biological
ENHERTU (fam‐trastuzumab deruxtecan) – New biological, new active substance, conditional Marketing Authorisation
The following centrally authorised products has been removed from the list:
EMPLICITI (elotuzumab) – Five years following its authorisation (May 2016)
LONSURF (Trifluridine/Tipiricil) – Five years following its authorisation (May 2016)
TALTZ (ixekizumab) – Five years following its authorisation (May 2016)
TRUBERZI (eluxadoline) – Withdrawal of marketing authorisation
UPTRAVI (selexipag) – Five years following its authorisation (June 2016)
ODEFSEY (emtricitabine/rilpivirine/tenofovir alafenamide) – Five years following its authorisation (June 2016)
KYPROLIS (carfilzomib) – Five years following its authorisation (November 2015)
LENVIMA (Lenvatinib) – Five years following its authorisation (June 2015)
LIXIANA (edoxaban) – Five years following its authorisation (July 2015)
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