Natalizumab injection

Form: IV Injection

Strength: 300 mg

Reference Brands: Tysabri(US & EU)

Category: Multiple sclerosis

Natalizumab injection, marketed as Tysabri, is approved in the US by the FDA and in the EU via EMA for multiple sclerosis and Crohn’s disease. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety data, manufacturing quality, and pharmacovigilance plans. In the US, the FDA reviews detailed clinical trial and safety data, while the EMA ensures compliance with regional safety and quality standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Compliance with regional regulations is essential for the timely approval, safe use, and global availability of natalizumab, supporting optimal patient management in autoimmune and neurological conditions worldwide.