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
Batches
Batches released for supply before 30 April 2025
Consent start
Consent no.
CON-1108
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
Therapeutic product type
Prescription medicines