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

This guidance 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

Revision 2 (current)

Guideline on core SmPC for human normal immunoglobulin for subcutaneous and intramuscular administration (SCIg/IMIg) - Revision 2

Adopted Reference Number: EMA/CHMP/BPWP/143744/2011 Rev.2

Overview of comments received on guideline on core SmPC for human normal immunoglobulin for subcutaneous and intramuscular administration (SCIg/IMIg) - Revision 2

Reference Number: EMA/58859/2026

Draft guideline on core SmPC for human normal immunoglobulin for subcutaneous and intramuscular administration (SCIg/IMIg) - Revision 2

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

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

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