CON-TGO91-327 - Sanofi-Aventis Australia Pty Ltd
Product names
- AUST R 101831 - KARVEZIDE 150/12.5 irbesartan 150 mg and hydrochlorothiazide 12.5 mg tablet blister pack
- AUST R 101833 - KARVEZIDE 300/12.5 irbesartan 300 mg and hydrochlorothiazide 12.5 mg tablet blister pack
- AUST R 102017 - AVAPRO HCT 150/12.5 irbesartan 150 mg and hydrochlorothiazide 12.5 mg tablet blister pack
- AUST R 102086 - AVAPRO HCT 300/12.5 irbesartan 300 mg and hydrochlorothiazide 12.5 mg tablet blister pack
- AUST R 129436 - AVAPRO HCT 300/25 irbesartan 300mg and hydrochlorothiazide 25mg tablet blister pack
- AUST R 129442 - KARVEZIDE 300/25 irbesartan 300mg and hydrochlorothiazide 25mg tablet blister pack
Sponsor
Decision Date
Duration
The consent is effective for all batches manufactured between 1 September 2020 and 31 March 2021.
Non-compliance with standard
The product(s) do not conform with the requirements of TGO 91 but are supplied with label(s) that have been approved by the TGA.
Supply/Import or Export
Supply
Therapeutic good type
Prescription medicines