CON-TGO91-217 - Merck Sharp and Dohme Australia Pty Limited
Product names
- AUST R 143574 - CUBICIN daptomycin 350 mg powder for injection vial
- AUST R 143586 - CUBICIN daptomycin 500 mg powder for injection vial
Decision Date
Duration
The consent is effective for all batches manufactured between 1 September 2020 and 30 November 2020.
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