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
ARTG
Batches
C1230
Consent start
Consent no.
CON-1184
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.
Therapeutic product type
Prescription medicines