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IMOJEV japanese encephalitis vaccine (live, attenuated) powder for injection vial plus diluent vial, Sanofi-Aventis Australia Pty Ltd , CON-727

Product name
IMOJEV japanese encephalitis vaccine (live, attenuated) powder for injection vial plus diluent vial
Sponsor name
Sanofi-Aventis Australia Pty Ltd
Batches
Batch 08A1912CB, expiry 22 May 2022, quantity: 7000 doses
Consent start
Consent no.
CON-727
Duration
The consent is effective from 12 January 2021 until 22 May 2022.
Standard
Subsection 9(3) of the Therapeutic Goods Order 91 Standard for labels of prescription and related medicines (TGO 91)
Non-compliance with standard
​The product does not conform to the requirements of subsection 9(3) of the Therapeutic Goods Order 91 Standard for labels of prescription and related medicines (TGO 91) in that the name of the medicine and the name of the active ingredient on the main label of the primary pack are not displayed as a cohesive unit and are separated by graphics.
Conditions imposed
          ​This consent applies only to supply IMOJEV japanese encephalitis vaccine (live, attenuated) powder for injection vial plus diluent vial [AUST R 162215] batch 08A1912CB (expiry 22 May 2022, quantity  7000 doses) for release in the Australian market; and       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
Supply
Therapeutic product type
Prescription medicines

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