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KISQALI ribociclib 200 mg (as succinate) film coated tablet blister pack, Novartis Pharmaceuticals Australia Pty Ltd, CON-1308
Product name
KISQALI ribociclib 200 mg (as succinate) film coated tablet blister pack
Sponsor name
Novartis Pharmaceuticals Australia Pty Ltd
Consent start
Consent no.
CON-1308
Duration
The consent is effective from 10 February 2025 until 31 March 2025.
Standard
Paragraph 8(1)(h) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product is labelled with the storage conditions "Store at 2-8°C
(Refrigerate, do not freeze)" instead of the current approved "Store below
30°C".
Import, Supply, &/or Export
supply
Therapeutic product type
Prescription medicines