Questions and Answers on the 'OPEN' Framework

Human medicines European public assessment report (EPAR): Agamree, vamorolone, Date of authorisation: 14/12/2023, Revision: 6, Status: Authorised

Human medicines European public assessment report (EPAR): Ponlimsi, denosumab, Date of authorisation: 17/11/2025, Revision: 1, Status: Authorised

Human medicines European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna), COVID-19 mRNA vaccine, Date of authorisation: 06/01/2021, Revision: 61, Status: Authorised

Human medicines European public assessment report (EPAR): Veyvondi, vonicog alfa, Date of authorisation: 31/08/2018, Revision: 13, Status: Authorised

Human medicines European public assessment report (EPAR): HyQvia, human normal immunoglobulin, Date of authorisation: 16/05/2013, Revision: 24, Status: Authorised

Human medicines European public assessment report (EPAR): Nyvepria, pegfilgrastim, Date of authorisation: 18/11/2020, Revision: 9, Status: Authorised

Human medicines European public assessment report (EPAR): Kostaive, zapomeran, Date of authorisation: 12/02/2025, Revision: 4, Status: Authorised

Human medicines European public assessment report (EPAR): Libtayo, cemiplimab, Date of authorisation: 28/06/2019, Revision: 22, Status: Authorised

Human medicines European public assessment report (EPAR): Imnovid (previously Pomalidomide Celgene), pomalidomide, Date of authorisation: 05/08/2013, Revision: 26, Status: Authorised