Human medicines European public assessment report (EPAR): Stivarga, regorafenib, Date of authorisation: 26/08/2013, Revision: 21, Status: Authorised

Human medicines European public assessment report (EPAR): Iasibon, ibandronic acid, Date of authorisation: 21/01/2011, Revision: 13, Status: Authorised

Human medicines European public assessment report (EPAR): Ruconest, conestat alfa, Date of authorisation: 28/10/2010, Revision: 13, Status: Authorised

Human medicines European public assessment report (EPAR): Pazenir, paclitaxel, Date of authorisation: 06/05/2019, Revision: 9, Status: Authorised

Human medicines European public assessment report (EPAR): Accofil, filgrastim, Date of authorisation: 17/09/2014, Revision: 17, Status: Authorised

Human medicines European public assessment report (EPAR): Piasky, Crovalimab, Date of authorisation: 22/08/2024, Status: Authorised

List of centrally authorised products with safety-related changes to the Product Information

Human medicines European public assessment report (EPAR): Fluad Tetra, influenza vaccine (surface antigen, inactivated, adjuvanted), Date of authorisation: 20/05/2020, Revision: 9, Status: Authorised

Human medicines European public assessment report (EPAR): Comirnaty, COVID-19 mRNA vaccine,tozinameran,riltozinameran and tozinameran,famtozinameran and tozinameran,raxtozinameran, Date of authorisation: 21/12/2020, Revision: 49, Status: Authorised

EU Individual Case Safety Report (ICSR) implementation guide business rules spreadsheets