CON-TGO91-226 - Bayer Australia Ltd
Product names
- AUST R 207595 - ADEMPAS riociguat 0.5 mg film-coated tablet blister pack
- AUST R 207599 - ADEMPAS riociguat 1 mg film-coated tablet blister pack
- AUST R 207597 - ADEMPAS riociguat 1.5 mg film-coated tablet blister pack
- AUST R 207598 - ADEMPAS riociguat 2 mg film-coated tablet blister pack
- AUST R 207596 - ADEMPAS riociguat 2.5 mg film-coated tablet blister pack
Sponsor
Decision Date
Duration
The consent is effective for all batches manufactured between 1 September 2020 and 31 October 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