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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 spp and Fusarium spp in patients intolerant/refractory to other therapies. Can be used for prophylaxis in high risk allogeneic hematopoietic stem cell transplant recipients (EU only).

 Application: Administered by intravenous infusion.

 

Presentations

 

NDC number

Packaging configuration

500 mg

70594-041-03

Carton of twelve 500 mg/100 mL bags

500 mg

70594-041-03

Carton of twelve 500 mg/100 mL bags

500 mg

70594-041-03

Carton of twelve 500 mg/100 mL bags

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: 11000 vials

US: 22000 vials

Regulatory documentation

EU dossier

US dossier

RoW* dossier

Packaging sizes

1 vial/pack

Shelf life

36 months

Storage conditions

Between 15-30°C (59-86°F)

* Products protected by valid patents are not offered for sale in countries, where the sale of such products constitutes a patent infringement.

* * Rest of the world