Product/Composition:- | Filgotinib tablets |
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Strength:- | 100 mg, 200 mg |
Form:- | Tablets |
Reference Brands:- | Jyseleca(EU) |
MOQ | As per the manufacturer batch size |
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Filgotinib inhibits Janus kinase 1 (JAK1), blocking cytokine signaling involved in inflammation. It reduces joint pain, swelling, and disease progression in rheumatoid arthritis. Benefits include rapid symptom relief, improved joint function, and better quality of life, with an oral formulation offering convenient long-term management of autoimmune conditions.
Filgotinib tablets are approved in the EU for rheumatoid arthritis, with the brand Jyseleca regulated by EMA, supported by dossiers demonstrating safety, efficacy, and manufacturing standards. In the US, FDA approval is pending or under review, as it is not yet marketed. Both regions require detailed dossiers for approval and ongoing pharmacovigilance. For expert assistance with regulatory dossiers, compliance, and registration, visit PharmaTradz. We support efficient market access for filgotinib tablets, ensuring adherence to European standards for safe, effective treatment of autoimmune diseases, helping navigate complex regulatory landscapes seamlessly.