ZYPREXA ZYDIS olanzapine 10 mg wafer blister pack, Pharmaco Australia Ltd, CON-1442
Product name
ZYPREXA ZYDIS olanzapine 10 mg wafer blister pack
Sponsor name
Pharmaco Australia Ltd
ARTG details
AUST R 73389
Batches
5931949A
Consent start
Consent no.
CON-1442
Duration
The consent is effective from 24 December 2025 until 31 December 2026.
Standard
Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product(s) do not conform because the labels have the incorrect sponsor
details; where they should contain the name and details of the current sponsor,
Pharmaco Australia Ltd., they instead have the details for the previous sponsor,
Eli Lilly Australia Ltd.
Conditions imposed
The labels to which this consent applies are those previously approved for the
former sponsor Eli Lilly Australia Ltd. and arrangements remain in place with
the former sponsor for the prompt referral of any queries or complaints
concerning the products to Pharmaco Australia Ltd. for the duration of this
consent.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines