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TAFINLAR dabrafenib (as mesilate) 10 mg dispersible tablet bottle , Novartis Pharmaceuticals Australia Pty Ltd , CON-1185
Product name
TAFINLAR dabrafenib (as mesilate) 10 mg dispersible tablet bottle
Sponsor name
Novartis Pharmaceuticals Australia Pty Ltd
Consent start
Consent no.
CON-1185
Duration
The consent is effective from 29 November 2023 until 29 November 2025.
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.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines