PRIMENE 10% amino acids solution for injection bottle, Baxter Healthcare Pty Ltd, CON-479
Product name
PRIMENE 10% amino acids solution for injection bottle
Sponsor name
Baxter Healthcare Pty Ltd
Consent start
Consent no.
CON-479
Standard
Subsections 9(3) and 9(6), paragraph 11(1)(a) and, subparagraph 11(2)(d)(ii) of the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines.
Non-compliance with standard
The product label does not List the names and quantities of the twenty (20)
active ingredients on separate lines under the trade nameList the names and
quantities of the twenty (20) active ingredients in a text size of not less than
2.5 millimetresList the quantities of the active ingredients using the required
statements of mass, instead only a single unit is used for each active
ingredient andList the weight of each active ingredient after dilution.
Therapeutic product type
Prescription medicines