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COARTEM 20 mg /120 mg artemether/lumefantrine 20 mg/120 mg dispersible tablet blister pack, Novartis Pharmaceuticals Australia Pty Ltd, CON-1108

Product name
COARTEM 20 mg /120 mg artemether/lumefantrine 20 mg/120 mg dispersible tablet blister pack
Sponsor name
Novartis Pharmaceuticals Australia Pty Ltd
ARTG details
Batches
Batches released for supply before 30 April 2025
Consent start
Consent no.
CON-1108
Duration
The consent is effective from 25 May 2023 until 30 April 2025.
Standard
Paragraph 8(1)(a), Paragraph 8(1)(h), Paragraph 8(1)(i), Paragraph 8(1)(j), Paragraph 8(1)(k), Paragraph 8(1)(o), Subsection 8(2). of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product labels are international labels and are not Australia-specific
Conditions imposed
1. a ‘Dear Healthcare Professional’ letter identical to that provided to the Therapeutic Goods Administration on 2 September 2020, will be supplied with each affected batch. 2. The ARTG number and the quantity of the medicine will be over-stickered onto the carton labels
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines