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GENOX 20 tamoxifen 20 mg (as citrate) tablet blister pack, Alphapharm Pty Ltd , CON-1203
Product name
GENOX 20 tamoxifen 20 mg (as citrate) tablet blister pack
Sponsor name
Alphapharm Pty Ltd
Batches
2855
Consent start
Consent no.
CON-1203
Duration
The consent is effective from the date of this letter until batch number 2855 is exhausted (approximately 12 weeks from the date of release).
Standard
Paragraph 8(1)(f) and 8(1)(g) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product blister labels do not include the prefixes for batch number "LOT"
and expiry date "EXP".
Conditions imposed
1. A ‘Dear Healthcare Provider’ letter identical to that provided to the
Therapeutic Goods Administration on 10 January 2024 will be supplied with
each affected batch, reminding patients to keep the blisters inside the
cartons, where the batch and expiry details are more clearly displayed.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines