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ADDAVEN concentrated injection ampoule, Fresenius Kabi Australia Pty Ltd, CON-499
Product name
ADDAVEN concentrated injection ampoule
Sponsor name
Fresenius Kabi Australia Pty Ltd
ARTG details
Consent start
Consent no.
CON-499
Duration
The consent is effective from the 21 July 2020 until 21 July 2022.
Standard
Paragraph 10(4)(d) of the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product ampoule label lists the active ingredients aselemental symbols with
oxidation state, instead of their full names sodium molybdatedehydrate (shown on
ampoule label as Mo6+), manganese chloride tetrahydrate (ampoule label Mn2+),
sodium fluoride (ampoule label F-), chromic chloride hexahydrate(ampoulelabel
Cr3+), ferric chloride hexahydrate (ampoule label Fe3+), zinc chloride (ampoule
label Zn2+), sodium selenite (ampoule label Se4+), potassium iodide (ampoule
label I-) andcupric chloride dehydrate (ampoule label Cu2+). Additionally, the
text size for the active ingredient elemental symbols is less than 2.0 mm
(approximately 1.3 mm).
Import, Supply, &/or Export
Import and supply
Therapeutic product type
Prescription medicines