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IMOJEV japanese encephalitis vaccine (live, attenuated) powder for injection vial plus diluent vial, Biocelect Pty Ltd (On behalf of Substipharm), CON-1076

Product name
IMOJEV japanese encephalitis vaccine (live, attenuated) powder for injection vial plus diluent vial
Sponsor name
Biocelect Pty Ltd (On behalf of Substipharm)
Consent start
Consent no.
CON-1076
Duration
The consent is effective from 3 March 2023 until 3 March 2024.
Standard
Section 8(1)(i) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The name and contact details of the current Sponsor or distributor of the medicine is not included on the carton and vial label, and the product information leaflet.
Conditions imposed
​1. The product must be supplied with the labels that were submitted with the s.14application on 21 February 2023; as follows&%2358;a) Carton label b) Powder for injection vial c) Diluent vial 2. Arrangements must be in place for the prompt referral of any queries orcomplaints concerning the product to the current Sponsor Biocelect Pty Ltd.3. Non-compliance with the Therapeutic Goods Order 91 Standard for labels ofprescription and related medicines is limited to this information.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines

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