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ONIVYDE irinotecan (as sucrosofate) 43 mg/10 mL nanoliposomal concentrated injection for infusion, Servier Laboratories (Aust) Pty Ltd, CON-1310
Product name
ONIVYDE irinotecan (as sucrosofate) 43 mg/10 mL nanoliposomal concentrated injection for infusion
Sponsor name
Servier Laboratories (Aust) Pty Ltd
Batches
Lot 001825; Lot 004892
Consent start
Consent no.
CON-1310
Duration
The consent is effective from 3 February 2025 until 31 October 2025.
Standard
Paragraph 8(1)(l) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product does not have the instructions for preparation, storage conditions
or the maximum storage period on either the label or a package insert.
Conditions imposed
A 'Dear Healthcare Provider' letter will be supplied with each affected batch
providing details of the missing information and weblinks to where it can be
found.
Import, Supply, &/or Export
supply
Therapeutic product type
Prescription medicines