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NIZAC nizatidine 300 mg capsule blister pack, Arrow Pharma Pty Ltd, CON-1128
Product name
NIZAC nizatidine 300 mg capsule blister pack
Sponsor name
Arrow Pharma Pty Ltd
ARTG details
Batches
7752569A,7752619A and 7752620A
Consent start
Consent no.
CON-1128
Duration
The consent is effective from 13 July 2023 until 30 November 2024.
Standard
Subparagraph 8(3)(e) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product(s) do not include the correct expiry date, that is, the date that
‘in relation to a product means the date (month and year) after which the
medicine should not be used
Conditions imposed
1. A ‘Dear Healthcare Provider’ letter identical to that provided to the
Therapeutic Goods Administration on 6 July 2023 will be supplied with each
affected batch including the updated shelf life for each batch.
Import, Supply, &/or Export
supply
Therapeutic product type
Prescription medicines