KIOVIG normal immunoglobulin (human) 1g/10 mL solution for injection vial, Takeda Pharmaceuticals Australia Pty Ltd, CON-782
Product name
KIOVIG normal immunoglobulin (human) 1g/10 mL solution for injection vial
Sponsor name
Takeda Pharmaceuticals Australia Pty Ltd
Batches
LE12W198BL (180 units)
Consent start
Consent no.
CON-782
Standard
Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product does not conform to the requirements of paragraph 8(1)(g) of
Therapeutic Goods Order No. 91 - Standard for labels of prescription and related
medicines, in that the information on the carton about expiry date is incorrect.
Conditions imposed
This exemption only applies to Batch LE12W198BL (180 units), which was
specified in the request.
Therapeutic product type
Prescription medicines