Clinical investigation of hepatitis B immunoglobulins

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Current effective version

Adopted guideline

Reference numberCHMP/BPWP/585257/2009
Effective from01/02/2016
KeywordsHepatitis B immunoglobulins, immunoprophylaxis of hepatitis B, liver transplantation hepatitis B induced liver failure
DescriptionThis 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.

Document history

First version 

Current version

Adopted guideline

Overview of comments

Draft guideline

In operation: 01/02/2016–present

Published: 24/05/2015

Published: 03/12/2012

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