Intravenous Immunoglobulin (IVIG)

Form: Intravenous infusion

Strength: 5% and 10%

Reference Brands: Gammagard, Flebogamma, Privigen, Octagam, Kiovig, Carimune(US & EU)

Category: Plasma Products

Intravenous Immunoglobulin (IVIG) injection, marketed as Gammagard, Privigen, Octagam, and others, is approved in the US by the FDA and in the EU via EMA for treating immunodeficiency and autoimmune disorders. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety, manufacturing standards, and pharmacovigilance plans. In the US, the FDA conducts rigorous review, while in the EU, EMA guidelines ensure regional compliance. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring regulatory compliance is essential for the safe, effective, and timely approval of IVIG products worldwide, supporting improved patient outcomes across multiple conditions.