Influenza vaccines - non-clinical and clinical module - Scientific guideline

Concept paper on the revision of the Non-clinical and Clinical Module of the influenza vaccines guideline

Human medicines European public assessment report (EPAR): CoAprovel, irbesartan,hydrochlorothiazide, Hypertension, Date of authorisation: 14/10/1998, Revision: 49, Status: Authorised

Human medicines European public assessment report (EPAR): Champix, varenicline, Tobacco Use Cessation, Date of authorisation: 25/09/2006, Revision: 38, Status: Authorised

Human medicines European public assessment report (EPAR): Venclyxto, venetoclax, Leukemia, Lymphocytic, Chronic, B-Cell, Date of authorisation: 04/12/2016, Revision: 16, Status: Authorised

Human medicines European public assessment report (EPAR): Comirnaty, tozinameran,riltozinameran and tozinameran,famtozinameran and tozinameran,COVID-19 mRNA Vaccine (nucleoside modified), COVID-19 virus infection, Date of authorisation: 21/12/2020, Revision: 45, Status: Authorised

Human medicines European public assessment report (EPAR): Fycompa, perampanel, Epilepsies, Partial, Date of authorisation: 23/07/2012, Revision: 32, Status: Authorised

Human medicines European public assessment report (EPAR): Benlysta, belimumab, Lupus Erythematosus, Systemic, Date of authorisation: 13/07/2011, Revision: 31, Status: Authorised

Methodology Working Party stakeholder interaction meeting, Online, from 07/12/2023 to 07/12/2023

EMA recommends approval of adapted Nuvaxovid COVID-19 vaccine targeting Omicron XBB.1.5