Levocetirizine Tablets

Form: Tablets

Strength: 5 mg

Reference Brands: Xyzal(US)

Category: ENT

Levocetirizine tablets, marketed as Xyzal, are approved in the US by the FDA and in the EU via EMA for allergic rhinitis and urticaria. Regulatory approval requires a comprehensive dossier with clinical efficacy, safety data, manufacturing practices, and pharmacovigilance plans. The FDA reviews clinical trial and safety data for timely approval, while the EMA ensures regional safety and manufacturing compliance. For dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper adherence supports swift approval, safe use, and global availability, enabling consumers worldwide to benefit from effective allergy relief and urticaria management supported by regional regulations.