Interferon Beta-1a injectable

Form: Injection

Strength: 30 mcg, 22 mcg or 44 mcg,125 mcg, 125 mcg, 150 mcg,175 mcg

Reference Brands: Avonex, Rebif, Plegridy(US &EU)

Category: Multiple sclerosis

Interferon Beta-1a, marketed as Avonex, Rebif, and Plegridy, is approved in the US by the FDA and in the EU via EMA for multiple sclerosis treatment. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety data, manufacturing quality, and pharmacovigilance plans. In the US, FDA review involves detailed analysis of clinical trial results and manufacturing processes, while the EU ensures compliance with regional standards. For guidance on dossier preparation, regulatory pathways, and market access strategies, visit PharmaTradz. Ensuring regional regulatory compliance is essential for the timely approval, safe use, and global availability of Interferon Beta-1a injection, supporting effective MS management worldwide.