The main aim of the guideline is to outline the information which should be included for the adjuvant in the marketing authorisation application (MAA) of an immunological veterinary medicinal product (IVMP).
This guideline replaces the ‘Note for Guidance on the use of adjuvanted veterinary vaccines’.
The guideline discusses the important aspects to consider for the adjuvant in an IVMP and provides guidance on the information on the adjuvant which should be included in Parts 2, 3 and 4 of the MAA. The d...
Europe - EMA - European Medicines Agency
Aflunov (Active substance: Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)) - Centralised - Yearly update - Commission Decision (2018)3066 of Tue, 15 May 2018
Europe -DG Health and Food Safety