CON-TGO91-163 - Teva Pharma Australia Pty Ltd
Product names
- AUST R 267385 - DUORESP SPIROMAX budesonide / formoterol (eformoterol) fumarate dihydrate 200 microgram / 6 microgram powder for inhalation dry powder inhaler - Batch number 506-10-1191
- AUST R 267386 - DUORESP SPIROMAX budesonide / formoterol (eformoterol) fumarate dihydrate 400 microgram / 12 microgram powder for inhalation dry powder inhaler - Batch number 506-10-1192
Sponsor
Decision Date
Duration
The consent is effective for all batches manufactured from 5 August 2020 until 30 September 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