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
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 21 February 2023; 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 this information.
Therapeutic product type
Prescription medicines