PRIMENE 10% amino acids solution for injection bottle, Baxter Healthcare Pty Ltd, CON-919
Product name
PRIMENE 10% amino acids solution for injection bottle
Sponsor name
Baxter Healthcare Pty Ltd
Consent start
Consent no.
CON-919
Standard
Subsections 9(3) and 9(6), paragraph 11(1)(a) and subparagraph 11(2)(d)(ii) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91)
Non-compliance with standard
The product does not confirm with the requirements of subsections 9(3) and 9(6),
paragraph 11(1)(a) and subparagraph 11(2)(d)(ii) of Therapeutic Goods Order No.
91 - Standard for labels of prescription and related medicines (TGO 91), in that
the product bottle labels do not list the names and quantities of the twenty
(20) active ingredients on separate lines under the trade name and in a text
size of not less than 2.5 millimetres, do not express the quantities of the
active ingredients using the required statements of mass and do not list the
weight of each active ingredient in a stated volume of the medicine after
preparation.
Conditions imposed
The labels to which this consent applies are those approved and dated 12 March
2019.
Therapeutic product type
Prescription medicines