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
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 [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.
Therapeutic product type
Prescription medicines