IRIS guide for applicants - How to create, submit and manage IRIS applications, for industry and individual applicants

Human medicines European public assessment report (EPAR): Usymro, ustekinumab, Date of authorisation: 14/08/2025, Revision: 3, Status: Authorised

Human medicines European public assessment report (EPAR): Bilprevda, denosumab, Date of authorisation: 17/09/2025, Revision: 2, Status: Authorised

Human medicines European public assessment report (EPAR): Tolvaptan Accord, tolvaptan, Revision: 1, Status: Authorised

Human medicines European public assessment report (EPAR): Onureg, azacitidine, Date of authorisation: 17/06/2021, Revision: 4, Status: Authorised

Human medicines European public assessment report (EPAR): Praluent, alirocumab, Date of authorisation: 23/09/2015, Revision: 26, Status: Authorised

Human medicines European public assessment report (EPAR): Ayvakyt, avapritinib, Date of authorisation: 24/09/2020, Revision: 11, Status: Authorised

Human medicines European public assessment report (EPAR): Nurzigma, pridopidine, Status: Application withdrawn

Human medicines European public assessment report (EPAR): Tysabri, natalizumab, Date of authorisation: 27/06/2006, Revision: 51, Status: Authorised

Human medicines European public assessment report (EPAR): Harvoni, ledispavir,sofosbuvir, Date of authorisation: 17/11/2014, Revision: 29, Status: Authorised