Hyperimmune Globulins Intravenous (IV) or Subcutaneous (SC)

Form: Intravenous (IV) or Subcutaneous (SC) Solution

Strength: 100 mg/mL or 50 mg/mL

Reference Brands: Tetanus IG (TIG), Varicella Zoster IG, Cytogam,RhoGAM,Hepatitis B Immune Globulin (HBIG)(US)

Category: Plasma Products

Hyperimmune globulins (IV), such as Cytogam or HBIG, are approved in the US by the FDA and in the EU via EMA for passive immunization against specific diseases like CMV, rabies, and hepatitis B. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. In the US, the FDA reviews detailed submissions for safety and efficacy, while the EMA ensures compliance with regional quality standards. For guidance on dossier preparation, regulatory pathways, and market access strategies, visit PharmaTradz. Ensuring compliance is essential for timely approval and safe worldwide use, supporting effective disease prevention.