During assessment of a Type II variation for changing the mouse potency test to comply with the revised Ph. Eur monograph for erysipelas vaccines, vaccine batch 8500 was accepted as being a reference vaccine and therefore this batch and those prior to it have to be accepted as being compliant with the conditions of the Marketing Authorisations for both products.
Denne batch og de foregående må derfor godkendes som værende i overensstemmelse med betingelserne for markedsføringstilladelserne for begge produkter.