ANDRODERM testosterone 24.3 mg per patch transdermal drug delivery system sachet, Teva Pharma Australia Pty Ltd, CON-936
Product name
ANDRODERM testosterone 24.3 mg per patch transdermal drug delivery system sachet
Sponsor name
Teva Pharma Australia Pty Ltd
Batches
100024620 and 100030031
Consent start
Consent no.
CON-936
Standard
Subsection 9(3)(a), Section 9(5) and Subsection 8(1)(j) of the Therapeutic Goods Order No.91 - Standard for labels of prescription and related medicines (TGO 91)
Non-compliance with standard
The product(s) do not conform to the requirements of TGO 91 Subsection 9(3)(a),
Section 9(5) and Subsection 8(1)(j), in that the product(s) tradename, active
ingredient and strength do not appear together; the active ingredient on the
main label is displayed in a text size height of 2.5 millimetres; and ethanol is
not declared on the carton label.
Therapeutic product type
Prescription medicines