Clinical investigation of human anti-D immunoglobulin for intravenous and/or intramuscular use

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Current effective version

Revision 1 - Adopted guideline

Reference numberCPMP/BPWG/575/99 Rev. 1
Published20/09/2007
Effective from01/04/2008
KeywordsAnti-D immunoglobulin, pregnancy, incompatible transfusion, Rh(D) negative
DescriptionThis document describes the information to be provided in the marketing authorisation application for a human anti-D immunoglobulin. It applies to products intended for use in prevention of Rh(D) immunisation in antenatal and postnatal prophylaxis, and treatment of Rh(D) negative persons after incompatible transfusions containing Rh(D) positive red blood cells. It covers biological data, clinical trials and patient follow up.


Document history

Revision 1 

Current version

Adopted guideline

 

Overview of comments

 

Draft guideline

In operation: 01/04/2008–present

 

Published: 13/03/2007

 

Published: 27/04/2007


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