We will have limited operations from 15:00 Wednesday 24 December 2025 (AEDT) until Friday 2 January 2026. Find out how to contact us during the holiday period.
VALGANCICLOVIR VIATRIS valganciclovir (as hydrochloride) 450 mg film-coated tablet bottle, Alphapharm Pty Ltd, CON-1184
Product name
VALGANCICLOVIR VIATRIS valganciclovir (as hydrochloride) 450 mg film-coated tablet bottle
Sponsor name
Alphapharm Pty Ltd
Batches
C1230
Consent start
Consent no.
CON-1184
Duration
The consent is effective from 4 December 2023 until 30 June 2024.
Standard
Assay for the active ingredient of United States Pharmacopoeia
Non-compliance with standard
The product does not conform to the requirements of The United States
Pharmacopeia Standard for Valganciclovir, in that the Assay for the active
ingredient was out of specification.
Conditions imposed
Batch release data for the next three production batches manufactured at the
site where the affected batch was manufactured will be provided to the TGA.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines