IVIG (Intravenous Immunoglobulin) solution

Form: Intravenous infusion

Strength: 5% or 10%

Reference Brands: Gammagard (Gamunex-C, Flebogamma),Privigen, Octagam, Gamunex-C(US)

Category: Immune Disorder

IVIG (Intravenous Immunoglobulin) solution, marketed as Gammagard or Privigen, is approved in the US by the FDA and in the EU via EMA for passive immunity against specific infections, such as varicella-zoster and other viral diseases. Regulatory approval requires a detailed dossier including clinical efficacy, safety, manufacturing quality, and pharmacovigilance plans. In the US, the FDA rigorously reviews clinical trial and production data, while the EMA ensures compliance with regional safety and quality standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper compliance is essential for timely approval and safe use of VIG products worldwide, supporting effective infection prevention.