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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-1210
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-1210
Duration
The consent is effective from 14 February 2024 until 30 June 2025.
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.14
application on 5 December 2023 and correspondence dated 12 January as follows:
a) Carton label
b) Powder for injection vial
c) Diluent vial
2. Arrangements must be in place for the prompt referral of any queries or
complaints concerning the product to the current Sponsor Biocelect Pty Ltd.
3. Non-compliance with the Therapeutic Goods Order 91 Standard for labels of
prescription and related medicines is limited to the information detailed in the
submission.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines