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EXTRANEAL 7.5% w/v icodextrin peritoneal dialysis solution twin bag with drainage bag AHB9849, Vantive Pty Ltd, CON-1256
Product name
EXTRANEAL 7.5% w/v icodextrin peritoneal dialysis solution twin bag with drainage bag AHB9849
Sponsor name
Vantive Pty Ltd
Batches
X72L8
Consent start
Consent no.
CON-1256
Duration
The consent is effective from 18 July 2024 until 31 August 2024.
Standard
Paragraph 8(1)(g) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product has the expiry date printed as 26 JUL (Year, Month) on the bag
where, as per Section 6 – Interpretations, the expiry date should be written as
Month, Year (JUL 26)
Conditions imposed
A consumer and healthcare provider notification letter identical to that
provided to the TGA on 9 July 2024 will be supplied with each affected batch
describing the incorrect date notation.
Import, Supply, &/or Export
supply
Therapeutic product type
Prescription medicines