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
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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