aripiprazole (ARIPIPRAZOLE GENERICHEALTH 5) 5 mg tablet blister pack, Generic Health Pty Ltd, CON-106
Product name
aripiprazole (ARIPIPRAZOLE GENERICHEALTH 5) 5 mg tablet blister pack
Sponsor name
Generic Health Pty Ltd
ARTG
176793
Consent start
Consent no.
CON-106
Standard
The requirements of Part 3-1 '“ Standards of the Therapeutic Goods Act 1989 (Cth).
Non-compliance with standard
The products do not comply with the default standard for the products, i.e. the
USP 39 monograph for Aripiprazole Tablets.#160;#160;
Conditions imposed
The products must continue to meet the currently approved finished product
specifications at release and expiry.
Therapeutic product type
Prescription medicines