Core summary of product characteristics for human normal immunoglobulin for subcutaneous and intramuscular use - Scientific guideline

This document describes the information to be included in the summary of product characteristics for human normal immunoglobulins for subcutaneous and/or intramuscular administration.

Keywords: Human normal immunoglobulin, primary immunodeficiency syndromes, hypogammaglobulinaemia, hepatitis A prophylaxis, immunomodulation

Current effective version

Guideline on core SmPC for human normal immunoglobulin for subcutaneous and intramuscular administration

Adopted Reference Number: EMA/CHMP/BPWP/143744/2011 Rev. 1 Summary:

This guideline describes the information to be included in the Summary of Product Characteristics

(SmPC) for human normal immunoglobulins for subcutaneous and/or intramuscular administration.

Revision 2

Guideline on core SmPC for human normal immunoglobulin for subcutaneous and intramuscular administration (SCIg/IMIg)

Draft: consultation closed Consultation dates: 05/12/2024 to 13/06/2025 Reference Number: EMA/CHMP/BPWP/143744/2011 rev.2

Document history - revision 1

Guideline on core SmPC for human normal immunoglobulin for subcutaneous and intramuscular administration

Adopted Reference Number: EMA/CHMP/BPWP/143744/2011 Rev. 1 Summary:

This guideline describes the information to be included in the Summary of Product Characteristics

(SmPC) for human normal immunoglobulins for subcutaneous and/or intramuscular administration.

Overview of comments received on 'Guideline on core SmPC for human normal immunoglobulin for subcutaneous and intramuscular administration'

Reference Number: EMA/CHMP/BPWP/356950/2013

Draft guideline on core summary of product characteristics for human normal immunoglobulin for subcutaneous and intramuscular administration

Draft: consultation closed Consultation dates: 31/07/2012 to 31/01/2013 Reference Number: EMA/CHMP/BPWP/143744/2011 rev. 1 Summary:

This guideline describes the information to be included in the summary of product characteristics for human normal immunoglobulins for subcutaneous or intramuscular administration.

Concept paper on revision of note for guidance on the clinical investigation of human normal immunoglobulin for subcutaneous and intramuscular use (CPMP/BPWG/283/00)

Draft: consultation closed Consultation dates: 16/12/2010 to 31/03/2011 Reference Number: EMA/CHMP/BPWP/761007/2010

Guideline on the Core SPC for human normal immunoglobulin for subcutaneous and intramuscular use (CPMP/BPWG/282/00)

Adopted Reference Number: CPMP/BPWG/282/00 Legal effective date: 01/01/2003