Modafinil tablet

Form: Tablet

Strength: 100 mg, 200 mg, 150 mg, 250 mg

Reference Brands: Provigil, Modalert, Armodafinil(US & EU)

Category: Multiple sclerosis

Modafinil tablets, marketed as Provigil, are approved in the US by the FDA and in the EU via EMA for narcolepsy, shift work sleep disorder, and excessive daytime sleepiness. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety data, manufacturing quality, and pharmacovigilance plans. In the US, the FDA reviews detailed clinical trial and manufacturing documents, while the EMA ensures compliance with regional standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring thorough regulatory compliance is essential for timely approval, safe use, and worldwide availability, supporting effective management of sleep disorders and improving patient health outcomes.