ZELDOX ziprasidone (as hydrochloride monohydrate) 80mg capsule blister pack, Viatris Pty Ltd , CON-1467
Product name
ZELDOX ziprasidone (as hydrochloride monohydrate) 80mg capsule blister pack
Sponsor name
Viatris Pty Ltd
Batches
MJ3518 and LA5173
Consent start
Consent no.
CON-1467
Duration
The consent is effective from 5 February 2026 until 31 July 2028.
Standard
The drug substance does not conform with the requirements of the European Pharmacopoeia with respect to the specification (0.10% for any unspecified impurity) in the related substances test. of European Pharmacopoeia
Non-compliance with standard
Batches of the drug substance have been found to contain an unspecified impurity
at a level above 0.10%.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines