
Fluconazole Oral Tablets
Form: Tablets
Strength: 50 mg, 100 mg, 150 mg, 200 mg
Reference Brands: Diflucan(EU & US)
Category: Anti-fungal
Fluconazole tablets are approved in the EU and US for treating fungal infections. In the EU, Pfizer’s Diflucan and generics are regulated by the EMA, supported by comprehensive dossiers demonstrating safety, efficacy, and manufacturing quality. In the US, the FDA approved Diflucan and generic versions based on detailed clinical data and biosimilarity assessments, with ongoing pharmacovigilance. Both regions require robust dossiers for approval and post-marketing surveillance. For expert assistance with pharmaceutical dossiers, regulatory submissions, and compliance, visit PharmaTradz, your trusted partner in regulatory solutions.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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