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ZYPREXA IM olanzapine 10mg powder for injection vial, Pharmaco Australia Ltd, CON-1334
Product name
ZYPREXA IM olanzapine 10mg powder for injection vial
Sponsor name
Pharmaco Australia Ltd
Batches
D795326, D787116
Consent start
Consent no.
CON-1334
Duration
The consent is effective from 7 March 2025 until 31 December 2025.
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 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