DRAXIMAGE MACROSALB kit for the preparation of Technetium Tc 99m Albumin Aggregated Injection vial, ANSTO, CON-621
Product name
DRAXIMAGE MACROSALB kit for the preparation of Technetium Tc 99m Albumin Aggregated Injection vial
Sponsor name
ANSTO
Consent start
Consent no.
CON-621
Standard
Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
8(1)(o) - the name of the medicine is not on at least three non-opposing sides
of the carton' 9(1)(b)(c) (e) - the information on the main label of the
medicine did not include the quantity or proportion of all active ingredients in
the medicine, nor the quantity of the medicine.' 9(3)(a)(i) - the name of the
medicine and the name(s) of active ingredient(s) on the main label did not
appear as a cohesive unit by the placement of the name and quantity of each
active ingredient together on separate lines of text immediately below the name
of the medicine.' 9(5) - Subject to subsections 9(6), 9(7), 9(8) and 9(9) - the
name of the active ingredient(s) and the quantity or proportion of active
ingredient(s) are not displayed in a text size of not less than 3.0
millimetres.' 10(4)(d) '“ (on the vial label) the name(s) of all active
ingredients in the medicine is not displayed in a text size of not less than 2.0
millimetres.
Therapeutic product type
Prescription medicines