Fluconazole IV

Form: Intravenous (IV) solution

Strength: 2 mg/mL (or higher concentrations)

Reference Brands: Diflucan IV(US & EU)

Category: Anti-fungal

Fluconazole IV is an antifungal approved in the EU and US for severe fungal infections. In the EU, Pfizer’s Diflucan IV and generics are regulated by EMA, supported by dossiers demonstrating quality, safety, and efficacy. In the US, the FDA approved Diflucan IV and biosimilars based on comprehensive clinical data and biosimilarity assessments, with continuous pharmacovigilance. Both regions require detailed dossiers for approval and post-marketing safety monitoring. For expert support with pharmaceutical dossiers and regulatory compliance, visit PharmaTradz, your trusted partner in regulatory solutions, ensuring smooth approval and market access for fluconazole IV formulations.