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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