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TIROFIBAN JUNO tirofiban (as hydrochloride) 12.5 mg/50 mL Concentrated Injection for infusion Vial, Juno Pharmaceuticals Pty Ltd, CON-1015
Product name
TIROFIBAN JUNO tirofiban (as hydrochloride) 12.5 mg/50 mL Concentrated Injection for infusion Vial
Sponsor name
Juno Pharmaceuticals Pty Ltd
Batches
HZ201 and HZ202
Consent start
Consent no.
CON-1015
Duration
The consent is effective from 13 October 2022 until 30 June 2023.
Standard
Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91)
Non-compliance with standard
The product is packaged in labels compliant with Therapeutic Goods Order No. 69
(TGO 69).
Conditions imposed
1. A ‘Dear Healthcare Provider’ letter identical to that provided to the
Therapeutic Goods Administration on 12 October 2022 will be supplied with
each affected batch.
2. The labels to which this consent applies are those previously approved to
comply with TGO 69.
Import, Supply, &/or Export
Supply
Therapeutic product type
Prescription medicines