EMA - Consultation on Draft guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg) - Revision 2

The draft of the new version of the Guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg) has been published for consultation. Interested contributors have until 31 May to comment. This guideline describes the information to be documented when an application is made for a marketing authorisation for a human normal immunoglobulin for subcutaneous and/or intramuscular use (SCIg/IMIg). The guidance covers clinical...

Publication Details

Journal
Industrias Culturais (Universidade de Coimbra)
Published
2025-02-05
DOI
https://doi.org/10.58079/13918
Primary Topic
Intramuscular injections and effects
Type
article
Field-Weighted Citation Impact
0.00
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article

EMA - Consultation on Draft guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg) - Revision 2

Industrias Culturais (Universidade de Coimbra)
Intramuscular injections and effects
article

EMA - Consultation on Draft guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg) - Revision 2

article en

Abstract

The draft of the new version of the Guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg) has been published for consultation. Interested contributors have until 31 May to comment. This guideline describes the information to be documented when an application is made for a marketing authorisation for a human normal immunoglobulin for subcutaneous and/or intramuscular use (SCIg/IMIg). The guidance covers clinical...

Industrias Culturais (Universidade de Coimbra)
Openalex Percentile: Top 39%
Intramuscular injections and effects
DOIOpen Access PDFOpenAlex
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EMA - Consultation on Draft guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg) - Revision 2 · Industrias Culturais (Universidade de Coimbra) (2025) | TGRS Research Map | TGRS