Updated on 30 July 2025:
'Summary of changes in July 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 July 2025
The following CAPs have been added to the list:
• Tepezza - New active substance and new biological
• Sephience - New active substance
• Yaxwer - New biological
• Junod - New biological
• Vevzuo - New biological
• Zadenvi - New biological
• Izamby - New biological
• Enwylma - New biological
• Denbrayce - New biological
• Ziihera - New active substance, New biological and Conditional marketing authorisation
• Evfraxy - New biological
• Alyftrek - New active substance
• Dazublys - New biological
• Rolcya – New biological
• Ezmekly - New active substance, Conditional marketing authorisation and PASS
• Bomyntra - New biological
• Aucatzyl - New active substance, New biological, Conditional marketing authorisation and PASS
• Itovebi - New active substance
• Conexxence - New biological
• Blenrep – New biological
The following CAPs have been removed from the list:
• Sixmo - Withdrawal of the medicinal product
• MenQuadfi - Five years following its authorisation (December 2020)