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.
REPLAGAL agalsidase alfa ghu 3.5 mg/3.5 mL concentrated injection vial, Shire Australia Pty Limited, CON-231
Product name
REPLAGAL agalsidase alfa ghu 3.5 mg/3.5 mL concentrated injection vial
Sponsor name
Shire Australia Pty Limited
Consent start
Consent no.
CON-231
Standard
Subclause 3(2)(l) of the Therapeutic Goods Order No.69 '“ General requirements for the labels for medicines
Non-compliance with standard
The product labels do not bear the current sponsor's address.
Conditions imposed
The labels to which this consent applies are those previously approved for
the former address Level 6, 123 Epping Road, North Ryde NSW 2113. Arrangements
are in place for the prompt referral of any queries or complaints concerning the
products to the current address (Level 39, 225 George Street, Sydney NSW 2000).
Therapeutic product type
Prescription medicines