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

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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

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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

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

Draft: consultation closed Consultation dates: to Reference Number: EMA/CHMP/BPWP/143744/2011 rev.2

English (EN) (499.57 KB - PDF)

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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

English (EN) (207.4 KB - PDF)

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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

English (EN) (192.97 KB - PDF)

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

Draft: consultation closed Consultation dates: to Reference Number: EMA/CHMP/BPWP/143744/2011 rev. 1

English (EN) (194.86 KB - PDF)

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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: to Reference Number: EMA/CHMP/BPWP/761007/2010

English (EN) (146.28 KB - PDF)

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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:

English (EN) (184.01 KB - PDF)

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