CON-TGO91-366 - Merck Sharp and Dohme Australia Pty Limited
Product names
- AUST R 203694 - ROSUZET Composite Pack 10mg+10mg ezetimibe 10mg tablets and rosuvastatin (as calcium) 10mg tablets composite pack
- AUST R 203692 - ROSUZET Composite Pack 10mg+20mg ezetimibe 10mg tablets and rosuvastatin (as calcium) 20mg tablets composite pack
- AUST R 203687 - ROSUZET Composite Pack 10mg+40mg ezetimibe 10mg tablets and rosuvastatin (as calcium) 40mg tablets composite pack
- AUST R 203690 - ROSUZET Composite Pack 10mg+5mg ezetimibe 10mg tablets and rosuvastatin (as calcium) 5mg tablets composite pack
- AUST R 203689 - EZALO Composite Pack 10mg+10mg ezetimibe 10mg tablets and rosuvastatin (as calcium) 10mg tablets composite pack
- AUST R 203691 - EZALO Composite Pack 10mg+20mg ezetimibe 10mg tablets and rosuvastatin (as calcium) 20mg tablets composite pack
- AUST R 203688 - EZALO Composite Pack 10mg+40mg ezetimibe 10mg tablets and rosuvastatin (as calcium) 40mg tablets composite pack
- AUST R 203693 - EZALO Composite Pack 10mg+5mg ezetimibe 10mg tablets and rosuvastatin (as calcium) 5mg tablets composite pack
Decision Date
Duration
The consent is effective for all batches manufactured between 1 September 2020 and 31 December 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