Clinical investigation of hepatitis B immunoglobulins - Scientific guideline

This document describes the information to be included in a marketing authorisation application for a hepatitis B immunoglobulin. It covers biological data, pharmacokinetics, clinical trials and patient follow-up.

Keywords: Hepatitis B immunoglobulins, immunoprophylaxis of hepatitis B, liver transplantation hepatitis B induced liver failure

Current effective version

Guideline on the clinical investigation of hepatitis B immunoglobulins

Adopted Reference Number: EMA/CHMP/BPWP/585257/2009 Legal effective date: 01/02/2016 Summary:

This guideline describes the information to be documented when an application is made for a marketing authorisation for a hepatitis B immunoglobulin. The guidance covers biological data, pharmacokinetics, clinical trials and patient follow-up. Guidance is also provided for authorised products where a significant change in the manufacturing process has been made.

Document history

Overview of comments received on 'Guideline on the clinical investigation of hepatitis B immunoglobulins'

Reference Number: EMA/CHMP/BPWP/356886/2013

Draft guideline on the clinical investigation of hepatitis-B immunoglobulins

Draft: consultation closed Consultation dates: 03/12/2012 to 03/06/2013 Reference Number: EMA/CHMP/BPWP/585257/2009 Summary:

This guideline describes the information to be documented when an application is made for a marketing authorisation for a hepatitis-B immunoglobulin. The guidance covers biological data, pharmacokinetics, clinical trials and patient follow-up. Guidance is also provided for authorised products where a significant change in the manufacturing process has been made.