Methotrexate Injectable

Form: Injectable (IV, IM, Subcutaneous)

Strength: 25 mg/mL, 50 mg/mL, 250 mg/10 mL vial

Reference Brands: Trexall (US)

Category: Arthritis

Methotrexate injectable is approved in the EU and US for treating rheumatoid arthritis, cancer, and autoimmune diseases. In the EU, Pfizer’s Trexall and other generics are regulated by EMA, supported by dossiers demonstrating safety, quality, and efficacy. In the US, FDA approval is based on comprehensive clinical data and biosimilarity assessments. Both regions require detailed dossiers for initial approval and ongoing pharmacovigilance. For expert assistance with regulatory dossiers, registration, and compliance, visit PharmaTradz. We support efficient market access for methotrexate injectable formulations, ensuring adherence to European and American standards for safe, effective treatment of autoimmune and oncological conditions.