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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 administration (SCIg/IMIg). The choice of text will depend on whether the product is for both subcutaneous and intramuscular administration or only one of these routes.

 


OpenEdition vous propose de citer ce billet de la manière suivante :
vroby (5 février 2025). EMA – Consultation on Draft Guideline on core SmPC for human normal immunoglobulin for subcutaneous and intramuscular administration (SCIg/IMIg). ELSIBI. Consulté le 16 mars 2026 à l’adresse https://doi.org/10.58079/13919


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