Core summary of product characteristics for human anti-D immunoglobulin for intravenous use - Scientific guideline

This document describes the information to be included in the summary of product characteristics for a human anti-D immunoglobulin for intravenous use.

Keywords: Anti-D immunoglobulin, pregnancy, incompatible transfusion, Rh(D) negative, summary of product characteristics (SPC)

Current effective version

Guideline on the core SmPC for human Anti-D immunoglobulin for intravenous use

Adopted Reference Number: EMA/CHMP/BPWP/319619/2005 Rev. 2 Legal effective date: 01/04/2017 Summary:

This guideline describes the information to be included in the Summary of Product Characteristics (SmPC) for a human anti-D immunoglobulin for intravenous use.

With respect to the previous version, this Core SmPC has been adapted to the current QRD template.

Document history - Revision 2

Guideline on the core SmPC for human Anti-D immunoglobulin for intravenous use

Adopted Reference Number: EMA/CHMP/BPWP/319619/2005 Rev. 2 Legal effective date: 01/04/2017 Summary:

This guideline describes the information to be included in the Summary of Product Characteristics (SmPC) for a human anti-D immunoglobulin for intravenous use.

With respect to the previous version, this Core SmPC has been adapted to the current QRD template.

Overview of comments received on ‘Draft Guideline on the core SmPC for human Anti-D immunoglobulin for intravenous use’ (EMA/CHMP/BPWP/319619/2005 Rev. 2)

Reference Number: EMA/CHMP/BPWP/379278/2016 Summary:

Overview of comments received on ‘Draft Guideline on the core SmPC for human Anti-D immunoglobulin for intravenous use’ (EMA/CHMP/BPWP/319619/2005 Rev. 2)

Draft guideline on the core SmPC for human Anti-D immunoglobulin for intravenous use

Draft: consultation closed Consultation dates: 11/02/2016 to 30/04/2016 Reference Number: EMA/CHMP/BPWP/319619/2005 Rev. 2 Summary:

This guideline describes the information to be included in the Summary of Product Characteristics (SmPC) for a human anti-D immunoglobulin for intravenous use.

Document history - Revision 1

Guideline on the Core SPC for human Anti-D immunoglobulin for intravenous use – Revision 1

Adopted Reference Number: CPMP/BPWG/574/99 Rev. 1 Legal effective date: 01/04/2008

Overview of comments received on the Core SPC for human Anti-D immunoglobulin for intravenous use CPMP/BPWP/319619/2005

Reference Number: EMEA/CHMP/BPWP/74960/2007

Draft guideline on the Core SPC for human Anti-D immunoglobulin for intravenous use – Revision 1

Draft: consultation closed Reference Number: CHMP/BPWP/319619/2005