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

The draft of the new version of the Guideline on core SmPC for human normal immunoglobulin for subcutaneous and intramuscular administration (SCIg/IMIg) has been published for consultation. Interested contributors have until 31 May to comment. The purpose of this core SmPC is to provide applicants and regulators with harmonised guidance on the information to be included in the Summary of product characteristics (SmPC) for a human normal immunoglobulin for subcutaneous and/or intramuscular ad...

Publication Details

Journal
Industrias Culturais (Universidade de Coimbra)
Published
2025-02-05
DOI
https://doi.org/10.58079/13919
Primary Topic
History of Computing Technologies
Type
article
Field-Weighted Citation Impact
0.00
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article

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

Industrias Culturais (Universidade de Coimbra)
History of Computing Technologies
article

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

article en

Abstract

The draft of the new version of the Guideline on core SmPC for human normal immunoglobulin for subcutaneous and intramuscular administration (SCIg/IMIg) has been published for consultation. Interested contributors have until 31 May to comment. The purpose of this core SmPC is to provide applicants and regulators with harmonised guidance on the information to be included in the Summary of product characteristics (SmPC) for a human normal immunoglobulin for subcutaneous and/or intramuscular ad...

Industrias Culturais (Universidade de Coimbra)
Openalex Percentile: Top 47%
History of Computing Technologies
DOIOpen Access PDFOpenAlex
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EMA - Consultation on Draft Guideline on core SmPC for human normal immunoglobulin for subcutaneous and intramuscular administration (SCIg/IMIg) · Industrias Culturais (Universidade de Coimbra) (2025) | TGRS Research Map | TGRS