VOLTAREN diclofenac sodium 12.5 mg suppository blister pack, Novartis Pharmaceuticals Australia Pty Ltd, CON-848
Product name
VOLTAREN diclofenac sodium 12.5 mg suppository blister pack
Sponsor name
Novartis Pharmaceuticals Australia Pty Ltd
Consent start
Consent no.
CON-848
Standard
Section 6 'name of an active ingredient'; and subparagraphs 10(14)(a)(v), 10(14)(a)(vii) and 10(14)(a)(viii) of Therapeutic Goods Order No. 91 '“ Standard for labels of prescription and related medicines
Non-compliance with standard
The product labels do not conform with the requirements of Section 6 'name of an
active ingredient'; and subparagraphs 10(14)(a)(v), 10(14)(a)(vii) and
10(14)(a)(viii) of Therapeutic Goods Order No. 91 '“ Standard for labels of
prescription and related medicines in that the blister labels for the above
mentioned products do not include the Australian approved name for the active
ingredient 'diclofenac sodium'; and the batch number and expiry date on the
blister labels are not preceded by suitable prefixes.
Conditions imposed
A 'Dear Healthcare Provider' letter will be supplied to healthcare
professionals with each affected batch outlining the non-compliance in the
product labelling.
The labels to which this consent applies are those provided with the
application dated 1 June 2021.
Therapeutic product type
Prescription medicines