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RIXUBIS nonacog gamma (rch) 2000 IU powder and solvent for solution for injection glass vials, Shire Australia Pty Ltd , CON-359
Product name
RIXUBIS nonacog gamma (rch) 2000 IU powder and solvent for solution for injection glass vials
Sponsor name
Shire Australia Pty Ltd
Batches
TNA18006AB and TNA18006AF
Consent start
Consent no.
CON-359
Standard
Paragraph 7(2)(l) of Therapeutic Goods Order No. 69 '“ General Requirements for Labels for Medicines 2017
Non-compliance with standard
The products labels do not include the name and address of the current sponsor
of the goods.
Conditions imposed
The labels to which this consent applies are those previously approved for the
former Sponsor, Baxter Australia, and arrangements are in place with the former
Sponsor, Baxter Australia, for the prompt referral of any queries or complaints
concerning the products to Shire Australia Pty Ltd.
Therapeutic product type
Prescription medicines