CUVITRU normal immunoglobulin (human) infusion 20% for subcutaneous use in glass vial, Shire Australia Pty Ltd, CON-223
Product name
CUVITRU normal immunoglobulin (human) infusion 20% for subcutaneous use in glass vial
Sponsor name
Shire Australia Pty Ltd
Consent start
Consent no.
CON-223
Standard
Paragraph 8(1)(i) of Therapeutic Goods Order No. 91-Standard for labels of prescription and related medicines
Non-compliance with standard
The labels do not include the name and address of the current sponsor or
supplier of the goods.
Conditions imposed
The labels to which this consent applies are those previously approved for
the outgoing sponsor Baxalta and arrangements are in place for the prompt
referral of any queries or complaints concerning the products to Shire.
Therapeutic product type
Prescription medicines