TAFINLAR dabrafenib (as mesilate) 50 mg capsule bottle, Novartis Pharmaceuticals Australia Pty Ltd , CON-1185
Product name
TAFINLAR dabrafenib (as mesilate) 50 mg capsule bottle
Sponsor name
Novartis Pharmaceuticals Australia Pty Ltd
Consent start
Consent no.
CON-1185
Standard
paragraphs 8(1)(f) and 8(1)(g) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The products with bottles labelled and packaged at Lek Pharmaceuticals do not
present the batch number and expiry date immediately preceded by their
respective prefixes on the bottles.
Conditions imposed
1. The consent is on the condition that the bottles are presented in cartons and
that the information on the cartons will comply with the requirements of
paragraphs 8(1)(f) and 8(1)(g) Therapeutic Goods Order No. 91.
2. As per the correspondence by email that the Company have reached out to the
manufacturer to rectify this issue and further information will be provided in
due course.
Therapeutic product type
Prescription medicines