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 April 2024
The following CAPs have been added to the list:
- Exblifep - cefepime / enmetazobactam – New active substance
- Ryzneuta - efbemalenograstim alfa – New active substance, new biological
The following CAPs have been removed from the list:
- Vaxzevria - COVID-19 Vaccine (ChAdOx1-S [recombinant]) – Withdrawal of marketing authorisation
- Talzenna - Five years following its authorisation (June 2019)
The following NAPs have been removed from the list:
- Annex I - List of cyproterone-acetate / ethinylestradiol-containing medicinal products in the European Union