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AusPAR: Valganciclovir

Australian Public Assessment Report

AusPAR

AusPAR: Valganciclovir [PDF, 792.1 KB]

AusPAR: Valganciclovir [Word, 1.4 MB]

Attachment: Product Information: Valganciclovir [PDF, 362.52 KB]

Attachment: Product Information: Valganciclovir [Word, 128.96 KB]

Attachment: Extract from Clinical Evaluation Report: Valganciclovir [PDF, 1.49 MB]

Attachment: Extract from Clinical Evaluation Report: Valganciclovir [Word, 3.54 MB]

Device/Product Name

Valcyte

Active ingredients

Valganciclovir

AusPAR Date

5 January 2016

Published

6 January 2016

Submission Number

PM-2014-01870-1-2

Submission Type

Major variation (dosage)

Decision

Approved