CON-TGO91-201 - Guerbet Australia Pty Ltd
Product names
- AUST R 49410 - OPTIRAY 240 Ioversol 25.45 g/50 mL injection vial -Batch number 20D0825
- AUST R 46640 - OPTIRAY 240 Ioversol 63.63 g/125 mL injection syringe -Batch numbers 19E1242 and 20D0822
- AUST R 20034 - OPTIRAY 320 Ioversol 13.56g/20mL injection -Batch numbers 19L2375, 20B0255, 20B0375
- AUST R 49422 - OPTIRAY 320 Ioversol 33.9g/50mL injection -Batch number 19K2325
- AUST R 46642- OPTIRAY 320 Ioversol 84.75 g/125 mL injection -Batch numbers 20B0442, 20C0622
- AUST R 47996 - OPTIRAY 350 Ioversol 74% w/v injection -Batch numbers: 20D0805, 20E0965
- AUST R 47997 - OPTIRAY 350 Ioversol 74% w/v injection -Batch numbers: 20B0275, 20B0435, 20D0775, 20E1005
- AUST R 51796 - OPTIRAY 350 ULTRAJECT Ioversol 74% w/v injection -Batch numbers 19C0722, 20B0332, 20B0492, 20C0672
- AUST R 70059 - OPTIRAY 350 Ioversol 74% w/v injection syringe -Batch numbers 19H1632, 20B0492, 20C0552, 20D0742, 20E1102
- ARTG 61983 - OPTIRAY 350 Ioversol 74.1g/100mL injection syringe -Batch numbers 20C0522, 20D0742, 20E0982
- ARTG 61984 - OPTIRAY 350 Ioversol 92.6g/125mL injection syringe -Batch numbers 20B0422, 20C0692, 20D0842
Sponsor
Decision Date
Duration
The duration of consent is for the batches specified above.
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