Clinical investigation of hepatitis B immunoglobulins

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Current effective version

Adopted guideline

Reference numberCHMP/BPWP/585257/2009
Published24/07/2015
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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