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

Current effective version

PDF iconRevision 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

PDF iconAdopted guideline

PDF iconOverview of comments

PDF iconDraft guideline

In operation: 01/04/2008–present

Published: 13/03/2007

Published: 27/04/2007


Related content


How useful was this page?

Add your rating