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DUTASTERIDE/TAMSULOSIN ZIMTAS 500/400 dutasteride 500 microgram and tamsulosin hydrochloride 400 microgram modified release capsule blister pack, ZimTAS Pty Ltd, CON-1394
Product name
DUTASTERIDE/TAMSULOSIN ZIMTAS 500/400 dutasteride 500 microgram and tamsulosin hydrochloride 400 microgram modified release capsule blister pack
Sponsor name
ZimTAS Pty Ltd
ARTG details
- 453949
Consent start
Consent no.
CON-1394
Duration
The consent is effective from 4 August 2025 until 4 August 2027.
Standard
The 'Dutasteride and Tamsulosin Hydrochloride Capsules' monograph of United States Pharmacopoeia
Non-compliance with standard
The products do not meet the USP 2025 Dutasteride and Tamsulosin Hydrochloride
Capsules monograph as: • the drug product release and expiry specifications
state limits of not less than (NLT) 35% and not less than (NLT) 30% of the
labelled amount respectively for the content of butylated hydroxytoluene. • the
USP Dutasteride and Tamsulosin Hydrochloride Capsules monograph specifies a
limit of 85.0%–110.0% of the labelled amount of butylated hydroxytoluene, if
present. • Butylated hydroxytoluene is present in the drug product as an
antioxidant.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines