CON-TGO91-256 - Novartis Pharmaceuticals Australia Pty Ltd
Product names
- AUST R 157954 - EXFORGE HCT 5/160/12.5 amlodipine/valsartan/hydrochlorothiazide tablet blister pack
- AUST R 158164 - EXFORGE HCT 10/160/12.5 amlodipine/valsartan/hydrochlorothiazide tablet blister pack
- AUST R 158162 - EXFORGE HCT 5/160/25 amlodipine/valsartan/hydrochlorothiazide tablet blister pack
- AUST R 158166 - EXFORGE HCT 10/160/25 amlodipine/valsartan/hydrochlorothiazide tablet blister pack
- AUST R 158168 - EXFORGE HCT 10/320/25 amlodipine/valsartan/hydrochlorothiazide tablet blister pack
Decision Date
Duration
The consent is effective for all batches manufactured between 1 September 2020 and 31 August 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