Product/Composition:- | Itraconazole IV solution |
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Strength:- | 200 mg/vial |
Form:- | Intravenous (IV) solution |
Reference Brands:- | Sporanox(US & EU) |
MOQ | As per the manufacturer batch size |
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Itraconazole IV inhibits fungal cytochrome P450 14α-demethylase, blocking ergosterol synthesis and disrupting fungal cell membranes. It provides broad-spectrum activity, rapid systemic treatment, and excellent tissue penetration. Benefits include effective management of severe fungal infections, reliable intravenous delivery, and a favorable safety profile for hospitalized patients.
Itraconazole IV solution is approved in the EU and US for severe fungal infections. In the EU, Janssen’s Sporanox IV is regulated by EMA, supported by dossiers demonstrating safety, efficacy, and quality. In the US, FDA approval is based on comprehensive clinical data, biosimilarity assessments, and ongoing pharmacovigilance. Both regions require detailed dossiers for initial approval and continuous safety monitoring. For expert assistance with pharmaceutical dossiers, regulatory submissions, and compliance, visit PharmaTradz, your trusted partner in regulatory solutions, facilitating efficient market access and ensuring adherence to regulatory standards for itraconazole IV formulations.