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

This 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.

Keywords: Anti-D immunoglobulin, pregnancy, incompatible transfusion, Rh(D) negative

Current effective version

Guideline on the clinical investigation of human Anti-D immunoglobulin for intravenous and/or intramuscular use

AdoptedReference Number: CPMP/BPWG/575/99 Rev. 1 Legal effective date: 01/04/2008

Document history

Overview of comments received on draft guideline on the clinical investigation of human Anti-D immunoglobulin for intravenous and/or intramuscular use CPMP/BPWG/575/99 REV. 1

Reference Number: EMEA/CHMP/BPWP/72096/2007

Draft guideline on the clinical investigation of human Anti-D immunoglobulin for intravenous and/or intramuscular use

Draft: consultation closedReference Number: CPMP/BPWG/575/99 Rev. 1