List of European Union reference dates and frequency of submission of periodic safety update reports (PSURs)

Organisation chart: Task Forces

Task Forces

New product information wording – Extracts from PRAC recommendations on signals adopted at the 23-26 October PRAC

Human medicines European public assessment report (EPAR): Tepmetko, tepotinib, Carcinoma, Non-Small-Cell Lung, Date of authorisation: 16/02/2022, Revision: 2, Status: Authorised

Human medicines European public assessment report (EPAR): Vyxeos liposomal (previously known as Vyxeos), daunorubicin,cytarabine, Leukemia, Myeloid, Acute, Date of authorisation: 23/08/2018, Revision: 9, Status: Authorised

Human medicines European public assessment report (EPAR): Kisqali, ribociclib, Breast Neoplasms, Date of authorisation: 22/08/2017, Revision: 14, Status: Authorised

Human medicines European public assessment report (EPAR): Spectrila, asparaginase, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Date of authorisation: 14/01/2016, Revision: 6, Status: Authorised

Human medicines European public assessment report (EPAR): Obizur, susoctocog alfa, Hemophilia A, Date of authorisation: 11/11/2015, Revision: 11, Status: Authorised

Human medicines European public assessment report (EPAR): Tysabri, natalizumab, Multiple Sclerosis, Date of authorisation: 27/06/2006, Revision: 41, Status: Authorised