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
Duration
The consent is effective for all batches of AUST R 96797 and AUST R 96810 products released from 30 August 2021 until 30 August 2023.
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.
Import, Supply, &/or Export
Import and supply
Therapeutic product type
Prescription medicines