COARTEM 20 mg /120 mg artemether/lumefantrine 20 mg/120 mg dispersible tablet blister pack, Novartis Pharmaceuticals Australia Pty Ltd, CON-588
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
Consent start
Consent no.
CON-588
Standard
Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product(s) do not conform to the requirements of Therapeutic Goods Order No.
91 Paragraph 8(1)(h), 8(1)(i), 8(1)(j), 8(1)(k) and Subsection 8(2). The
product(s) labels are international labels and are not Australia-specific.
Conditions imposed
1. a 'Dear Healthcare Professional' letter identical to that provided to the TGA
on 2 September 2020 (TRIM reference D20-3286353) 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