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ONIVYDE irinotecan (as sucrosofate) 43 mg/10 mL nanoliposomal concentrated injection for infusion, Servier Laboratories (Aust) Pty Ltd, CON-1411
Product name
ONIVYDE irinotecan (as sucrosofate) 43 mg/10 mL nanoliposomal concentrated injection for infusion
Sponsor name
Servier Laboratories (Aust) Pty Ltd
Batches
Lot 004892
Consent start
Consent no.
CON-1411
Duration
The consent is effective from 19 September 2025 until 30 April 2026.
Standard
Paragraph 8(1)(l) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The products do not conform because the label and package insert does not have
the instructions for preparation, storage conditions or the maximum storage
period.
Conditions imposed
A ‘Dear Healthcare Provider’ letter will be supplied with each affected batch
providing details of the missing information and weblinks to further
information.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines