CON-TGO91-192 - Bayer Australia Ltd
Product names
- AUST R 270517 - KYLEENA levonorgestrel 19.5 mg intrauterine drug delivery system sachet
Sponsor
Decision Date
Duration
The consent is effective for all batches manufactured between 1 September 2020 and 30 April 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