Teriflunomide tablets

Form: Tablet

Strength: 7 mg and 14 mg tablets

Reference Brands: Aubagio(US & EU)

Category: Multiple sclerosis

Teriflunomide tablets, marketed as Aubagio, are approved in the US by the FDA and in the EU via EMA for relapsing forms of multiple sclerosis (MS). Regulatory approval requires a comprehensive dossier including clinical trial data, safety profiles, manufacturing standards, and pharmacovigilance plans. In the US, the FDA reviews detailed clinical and quality data for approval, while the EMA ensures compliance with regional safety and manufacturing standards. For guidance on dossier preparation, regulatory pathways, and market access strategies, visit PharmaTradz. Ensuring regulatory compliance is essential for timely approval, safe use, and broader global availability of teriflunomide tablets, supporting MS patient management worldwide.