GLIVEC imatinib 100mg tablet blister pack, Novartis Pharmaceuticals Australia Pty Ltd, CON-1183
Product name
GLIVEC imatinib 100mg tablet blister pack
Sponsor name
Novartis Pharmaceuticals Australia Pty Ltd
Batches
W9078
Consent start
Consent no.
CON-1183
Standard
Subparagraph 8(1)(i) & Subparagraph Section 9(1)(b) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product label includes the name of the New Zealand Sponsor (Novartis New
Zealand Limited) in place of the Australian Sponsor (Novartis Pharmaceuticals
Australia Pty Ltd) and the active ingredient in expressed as 'imatinib' in place
of 'imatinib (as mesilate)'.
Conditions imposed
A Dear Healthcare Professional letter identical to that provided to the
Therapeutic Goods Administration on 24 November 2023 will be supplied with each
affected batch describing the differences between the provided label and the
Australian approved label.
2. The Australian Registration number (AUST R) will be over-stickered onto the
label, as described in the email dated 24 November 2023.
Therapeutic product type
Prescription medicines