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ELOCTATE efmoroctocog alfa (rhu) 500 IU powder for injection vial and diluent pre-filled syringe, Sanofi-Aventis Australia Pty Ltd, CON-358
Product name
ELOCTATE efmoroctocog alfa (rhu) 500 IU powder for injection vial and diluent pre-filled syringe
Sponsor name
Sanofi-Aventis Australia Pty Ltd
Consent start
Consent no.
CON-358
Standard
Paragraph 8(1)(i) in the Therapeutic Goods Order No.91 '“ Standard for labels of prescription and related medicines. (TGO No. 91)
Non-compliance with standard
The label does not include the name and contact details of the current sponsor
and sponsorship was not changed in the previous twelve months
Conditions imposed
Processes/measures are in place to ensure there are no gaps in
communication of medical information to patients and safety reporting.
The labels to which this consent applies are those previously approved for
the former sponsor, Bioverativ Australia Pty Ltd, and arrangements are in place
for prompt referral of any queries or complaints concerning the products to
Sanofi-Aventis Australia Pty.
Therapeutic product type
Prescription medicines