Praziquantel tablets

Form: Tablets

Strength: 600 mg

Reference Brands: Biltricide(US & EU)

Category: Anthelmintic

Praziquantel tablets, marketed as Biltricide, are approved in the US by the FDA and in the EU via EMA for treating schistosomiasis, tapeworms, and trematodes. Regulatory approval requires comprehensive dossiers 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 standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper adherence to regional regulations supports swift approval, safe use, and global availability, helping manage parasitic infections effectively across healthcare regions worldwide.