Work

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

Year: 2025

Type: other

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...

Source: Industrias Culturais (Universidade de Coimbra)

DOI: 10.58079/13919

Author: Vroby

Language: English

Topic: Healthcare Regulation

Subfield: Health Information Management

Field: Health Professions

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: green

OpenAlex ID: W6955236883

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