Cyclizine Tablet

Form: Tablets

Strength: 50 mg

Reference Brands: Marezine, Cyclivert, and Bonine(US)

Category: Antiemetic

Cyclizine tablets, marketed as Motion-Time and other generic brands, are approved in the US by the FDA and in the EU via EMA for nausea, motion sickness, and vertigo. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety profiles, manufacturing standards, and pharmacovigilance plans. The FDA reviews detailed clinical trial and quality data, 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 timely approval, safe use, and worldwide availability, helping manage nausea and vertigo effectively across healthcare settings globally.