
Terbinafine Tablets
Form: Tablets
Strength: 250 mg
Reference Brands: Lamisil(US & EU)
Category: Anti-fungal
Terbinafine tablets are approved in the EU and US for treating dermatophyte skin and nail infections. In the EU, Novartis’s Lamisil is regulated by EMA, supported by dossiers demonstrating safety, efficacy, and manufacturing quality. In the US, FDA approval is based on comprehensive clinical data, biosimilarity, and pharmacovigilance. Both regions require detailed dossiers for initial approval and ongoing safety monitoring. For expert assistance with regulatory dossiers, compliance, and submissions, visit PharmaTradz. We ensure smooth market access for terbinafine tablets, helping you meet European and American standards for safe, effective antifungal therapy.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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