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Voriconazole vials

Voriconazole is a broad spectrum triazole antifungal agent.

Indication: Used in the treatment of patients with progressive, possibly life-threatening fungal infections such as candidaemia in non-neutropenic patients, invasive candidiasis in skin, abdomen, kidney, bladder wall and wounds, invasive aspergillosis and infections caused by Scedosporium apiospermum and Fusarium spp in patients intolerant/refractory to other therapies.

 Application: Administered by intravenous infusion.

 

Dosage form

Lyophilized vials

Strength

200mg

Compliance

Ph. Eur.

USP

Manufacturing site

CMO for Xellia Pharmaceuticals ApS

Release site

CMO for Xellia Pharmaceuticals ApS

Site registered

EU GMP issued by Medicines and Healthcare products Regulatory Agency

US FDA

Other health authorities

Batch size

EU: 10500 vials

US: 21000 vials

Regulatory documentation

US dossier

RoW** dossier

Packaging sizes

1 vial/pack

Shelf life

36 months

Storage conditions

Between 15-30°C (59-86°F)

* * Rest of the World