Product/Composition:- | Meclizine tablet |
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Strength:- | 25 mg |
Form:- | Tablets |
Reference Brands:- | Antivert, Bonine, Dramamine(US) |
MOQ | As per the manufacturer batch size |
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Meclizine is an antihistamine that blocks H1 receptors, reducing vestibular activity and nausea. It effectively prevents and relieves motion sickness, vertigo, and dizziness. Benefits include rapid symptom relief, improved balance, decreased nausea, and support for inner ear disorders, enhancing comfort and safety during travel or vestibular dysfunction.
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.