Ocrelizumab injection

Form: Injection

Strength: 300 mg

Reference Brands: Ocrevus(EU & US)

Category: Multiple sclerosis

Ocrelizumab, marketed as Ocrevus, is approved in the US by the FDA and in the EU via EMA for relapsing and primary progressive multiple sclerosis. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety data, manufacturing processes, and pharmacovigilance plans. In the US, the FDA reviews detailed clinical trial results and manufacturing standards, while the EMA ensures regional safety and quality compliance. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring regional regulatory adherence is critical for timely approval, safe use, and global availability, supporting optimal MS management and patient outcomes worldwide.