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ALEPAM 30 oxazepam 30 mg tablet blister pack, Alphapharm Pty Ltd , CON-1058
Product name
ALEPAM 30 oxazepam 30 mg tablet blister pack
Sponsor name
Alphapharm Pty Ltd
ARTG details
Batches
8145371 and 8149184
Consent start
Consent no.
CON-1058
Duration
The consent is effective from the date of this letter until the affected batches are exhausted.
Standard
Paragraph 9(1)(d) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product(s) incorrectly refer to the dosage form as “film coated tablets”
whereas the correct dosage form is “tablets”.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines