Interferon Beta-1b injection

Form: Injectable Solution

Strength: 250 mcg

Reference Brands: Betaseron, Extavia(US)

Category: Multiple sclerosis

Interferon Beta-1b, marketed as Betaseron and Extavia, 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, the FDA reviews detailed clinical trials and manufacturing standards, while the EMA ensures compliance with regional safety and quality requirements. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring regional regulatory compliance supports the timely approval, safe use, and global availability of Interferon Beta-1b, providing effective MS management worldwide.