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
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
1. A 'Dear Doctor' letter identical to that provided to the Therapeutic Goods
Administration on 8 July 2022 will be supplied with each affected batch.
2. 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'
Therapeutic product type
Prescription medicines