Rituximab IV

Form: Intravenous (IV) Solution

Strength: 100 mg/10 mL, 1000 mg/50 mL

Reference Brands: Rituxan (US); Mabthera (EU)

Category: Arthritis

Rituximab IV is approved in the EU and US for rheumatoid arthritis, non-Hodgkin’s lymphoma, and other autoimmune diseases. In the EU, brands like Mabthera are regulated by EMA, supported by dossiers demonstrating safety, efficacy, and manufacturing quality. In the US, FDA approval is based on extensive clinical trial data, biosimilarity studies, and pharmacovigilance. Both regions require detailed dossiers for initial approval and ongoing safety monitoring. For expert assistance with regulatory dossiers, compliance, and registration, visit PharmaTradz. We help facilitate efficient market access for rituximab IV formulations, ensuring adherence to European and American standards for safe, effective biologic therapies.