
Filgotinib tablets
Form: Tablets
Strength: 100 mg, 200 mg
Reference Brands: Jyseleca(EU)
Category: Arthritis
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.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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