Website maintenance took place on Thursday 30 April 2026. If you experience any issues, please contact us.
HEXVIX hexaminolevulinate (as hydrochloride) 85 mg powder for intravesical solution plus diluent, Juno Pharmaceuticals Pty Ltd, CON-917
Product name
HEXVIX hexaminolevulinate (as hydrochloride) 85 mg powder for intravesical solution plus diluent
Sponsor name
Juno Pharmaceuticals Pty Ltd
Batches
HA2904
Consent start
Consent no.
CON-917
Duration
The consent is effective from 28 February 2022 until 28 February 2023.
Standard
Paragraph 8(1)(h) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91)
Non-compliance with standard
The product does not conform to the requirements of paragraph 8(1)(h) of
Therapeutic Goods Order No. 91 - Standard for labels of prescription and related
medicines (TGO 91), in that the product displays previously approved storage
conditions ‘Store below 25°C’ instead of the current approved storage conditions
‘Store below 30°C’.
Conditions imposed
The labels to which this consent applies are those supplied with the letter
dated 1 February 2022.
Import, Supply, &/or Export
Import and supply
Therapeutic product type
Prescription medicines