Last updated on 22-8-2019 by Anonymous (niet gecontroleerd)
Sci. report, recommendat°, guidance doc., directive, monograph
SCIENSANO
Trefwoorden
Samenvatting:
The current hepatitis A vaccine (HAV), inactivated, non-adsorbed, European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) is used for the in vitro potency assay of HAVas prescribed by the Ph. Eur. general chapter 2.7.14 Assay of hepatitis A vaccine. This reference preparation was calibrated in 2008 through an international collaborative study and was assigneda potency of 12 IU/mL. During use of this BRP it appeared to be inapplicable in certain cases due to a low nominal antigen content. Consequently, the European Directorate for the Qualityof Medicines and HealthCare (EDQM…