Planned maintenance may cause outages to the Department of Health and Aged Care’s network from 5:15 pm AEDT on 30 November to 10:00 pm AEDT on 1 December 2024. Access to TGA databases such as TBS Portal, ARTG and DAEN may be affected. We apologise for any inconvenience.
ADYNOVATE rurioctocog alfa pegol (rch) 250 IU powder for injection vial with diluent vial, Takeda Pharmaceuticals Australia Pty Ltd, CON-632
Product name
ADYNOVATE rurioctocog alfa pegol (rch) 250 IU powder for injection vial with diluent vial
Sponsor name
Takeda Pharmaceuticals Australia Pty Ltd
ARTG
Consent start
Consent no.
CON-632
Standard
Section 8(1)(i) of the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product labels do not include the correct name of the sponsor of the
medicine.
Conditions imposed
The labels to which this consent applies are those previously approved for the
former sponsor Shire and arrangements are in place with the former sponsor for
the prompt referral of any queries or complaints concerning the products to
Takeda Pharmaceuticals Australia Pty Ltd [the current sponsor].
Therapeutic product type
Prescription medicines