Human medicines European public assessment report (EPAR): Heplisav B, hepatitis B surface antigen, Hepatitis B, Date of authorisation: 18/02/2021, Revision: 5, Status: Authorised

Human medicines European public assessment report (EPAR): Brintellix, vortioxetine, Depressive Disorder, Major, Date of authorisation: 18/12/2013, Revision: 23, Status: Authorised

Human medicines European public assessment report (EPAR): Halaven, eribulin, Breast Neoplasms;Liposarcoma, Date of authorisation: 17/03/2011, Revision: 29, Status: Authorised

Withdrawn application: Vivjoa, Oteseconazole, Date of withdrawal: 24/08/2023, Initial authorisation

Human medicines European public assessment report (EPAR): Thiotepa Riemser, thiotepa, Hematopoietic Stem Cell Transplantation;Neoplasms, Date of authorisation: 26/03/2021, Revision: 4, Status: Authorised

Human medicines European public assessment report (EPAR): Prialt, ziconotide, Injections, Spinal;Pain, Date of authorisation: 21/02/2005, Revision: 30, Status: Authorised

Human medicines European public assessment report (EPAR): Neulasta, pegfilgrastim, Neutropenia;Cancer, Date of authorisation: 22/08/2002, Revision: 39, Status: Authorised

Human medicines European public assessment report (EPAR): Alli (previously Orlistat GSK), orlistat, Obesity, Date of authorisation: 22/07/2007, Revision: 19, Status: Authorised

List of signals discussed at PRAC since September 2012

New product information wording: extracts from PRAC recommendations on signals adopted at the 25-28 September 2023 PRAC