REPLAGAL agalsidase alfa ghu 3.5mg/3.5mL concentrated injection vial, Takeda Pharmaceuticals Australia Pty Ltd, CON-632
Product name
REPLAGAL agalsidase alfa ghu 3.5mg/3.5mL concentrated injection vial
Sponsor name
Takeda Pharmaceuticals Australia Pty Ltd
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