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ADDAVEN concentrated injection ampoule, Fresenius Kabi Australia Pty Ltd, CON-914
Product name
ADDAVEN concentrated injection ampoule
Sponsor name
Fresenius Kabi Australia Pty Ltd
ARTG details
Batches
12RAB94
Consent start
Consent no.
CON-914
Duration
The consent is effective from 18 February 2022 until 31 December 2023.
Standard
Paragraphs 8(1)(i), 10(2)(a) and 10(2)(f) 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 paragraphs 8(1)(i), 10(2)(a)
and 10(2)(f) of Therapeutic Goods Order No. 91 - Standard for labels of
prescription and related medicines (TGO 91), in that the product does not
contain the name and contact details of the sponsor, name and quantity of each
excipient in the stated volume of fill of the injection in the container, or the
statement ‘Use in one patient in one occasion only. Contains no antimicrobial
preservative'.
Conditions imposed
1. A customer letter identical to that provided to the TGA on 18 February 2022
will be supplied with each affected batch.
2. Supply and use of the above referenced batch are restricted to the
circumstances proposed in the application (use in compounding facilities
only).
3. The AUST R will be over-stickered on the carton as advised in the letter
dated 24 January 2022.
Import, Supply, &/or Export
Import and supply
Therapeutic product type
Prescription medicines