We’re experiencing issues for some mobile devices with our ARTG dataset filter function. We apologise for any inconvenience while we work to fix this.
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