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SEASONIQUE levonorgestrel/ethinylestradiol 150 ug/30 ug film coated tablets and ethinylestradiol 10 ug film coated tablets blister composite pack, Theramex Australia Pty Ltd, CON-750
Product name
SEASONIQUE levonorgestrel/ethinylestradiol 150 ug/30 ug film coated tablets and ethinylestradiol 10 ug film coated tablets blister composite pack
Sponsor name
Theramex Australia Pty Ltd
Consent start
Consent no.
CON-750
Duration
The consent is effective for all batches of the product manufactured from 8 February 2021 until 31 December 2021.
Standard
Section 6, subsection 9(3) and paragraph 11(1)(b) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91)
Non-compliance with standard
The product packaging does not include the Australian approved name for the
active ingredient “ethinylestradiol”; the medicine name and the active
ingredients do not appear as a cohesive unit on the main label; and includes the
abbreviation “?g” instead of ‘microgram’ for the quantity of the active
ingredients.
Import, Supply, &/or Export
Import and supply
Therapeutic product type
Prescription medicines