Meclizine Tablet

Form: Tablets

Strength: 25 mg

Reference Brands: Antivert, Bonine, Dramamine(US)

Category: Antiemetic

Meclizine tablets, marketed as Antivert and branded generics, are approved in the US by the FDA and in the EU via EMA for motion sickness, vertigo, and nausea. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. The FDA reviews clinical trial and quality data for timely approval, while the EMA ensures compliance with regional safety and manufacturing regulations. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper adherence to regional requirements supports swift approval, safe usage, and global availability, helping patients worldwide manage vestibular issues and nausea effectively for improved safety and comfort.