Posaconazole Oral Suspension

Form: Oral Suspension

Strength: 40 mg/mL

Reference Brands: Noxafil(US & EU)

Category: Anti-fungal

Posaconazole oral suspension is approved in the EU and US for prophylaxis and treatment of invasive fungal infections. In the EU, MSD’s Noxafil suspension is regulated by EMA, supported by dossiers demonstrating safety, efficacy, and quality. In the US, FDA approval is based on comprehensive clinical data and biosimilarity assessments, with ongoing pharmacovigilance. Both regions require detailed regulatory dossiers for initial approval and continual safety monitoring. For expert support with dossiers, regulatory submissions, and compliance, visit PharmaTradz. We help ensure smooth market entry and adherence to European and American standards, enabling effective management of fungal infections with posaconazole oral suspension.