CON-TGO91-259 - Accord Healthcare
Product names
- AUST R 184833 - MONTELUKAST SANDOZ 5 montelukast 5 mg (as sodium) chewable tablet blister pack
- AUST R 184832 - MONTELUKAST SANDOZ 4 montelukast 4 mg (as sodium) chewable tablet blister pack
- AUST R 184830 - MONTELUKAST SANDOZ 10 montelukast 10 mg (as sodium) film-coated tablet blister pack
Sponsor
Decision Date
Duration
The consent is effective for all batches manufactured between 1 September 2020 and 29 January 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