INQOVI 35/100 decitabine 35 mg and cedazuridine 100 mg tablet blister pack, Otsuka Australia Pharmaceutical Pty Ltd, CON-965
Product name
INQOVI 35/100 decitabine 35 mg and cedazuridine 100 mg tablet blister pack
Sponsor name
Otsuka Australia Pharmaceutical Pty Ltd
Batches
1919298
Consent start
Consent no.
CON-965
Duration
The consent is effective from 8 July 2022 until 31 January 2025
Standard
Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91)
Non-compliance with standard
The product does not comply with TGO 91 because it is labelled for the United States market and does not include the full name of the medicine; storage conditions in the required format; Australian sponsor or distributor details; declaration of “lactose as sugars”; name of the medicine on at least three non-opposing sides of the carton; space for dispensing label; and name and quantity of each active ingredient together on separate lines.
Conditions imposed
A ‘Dear Doctor’ letter identical to that provided to the Therapeutic Goods Administration on 8 July 2022 will be supplied with each affected batch.The labels to which this consent applies are those provided in the application dated 8 June 2022 3. the product(s) carton labels will be overstickered with The Australian registration number Australian sponsor or distributor details The warning statements “PRESCRIPTION ONLY MEDICINE” and “KEEP OUT OF REACH OF CHILDREN”
Import, Supply, &/or Export
Import and supply
Therapeutic product type
Prescription medicines