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QLAIRA estradiol valerate / dienogest tablets composite pack in wallet pack, Bayer Australia Ltd , CON-1367
Product name
QLAIRA estradiol valerate / dienogest tablets composite pack in wallet pack
Sponsor name
Bayer Australia Ltd
Batches
BN WEX8XB
Consent start
Consent no.
CON-1367
Duration
The consent is effective from 16 June 2025 until 31 December 2025.
Standard
Paragraphs 8(1)(e) and 8(1)(n) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product does not conform because the medicine is supplied as a 3-pack of 28
tablets. A sticker containing the total quantity (3 x 28) and a barcode, has
been omitted from being attached to the plastic film-coated packaging used to
bundle the 3 packets.
Conditions imposed
A ‘Dear Healthcare Provider’ letter will be supplied with each affected batch
identifying the lack of barcode to inform medicine providers of the error and
ensure they are aware that the product should still be sold as the 3 x 28 pack
combined.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines