ONCASPAR pegaspargase 3750 units/5 mL powder for solution injection/infusion vial, Servier Laboratories (Aust) Pty Ltd, CON-1028
Product name
ONCASPAR pegaspargase 3750 units/5 mL powder for solution injection/infusion vial
Sponsor name
Servier Laboratories (Aust) Pty Ltd
Consent start
Consent no.
CON-1028
Standard
subsection 7(1) and Section 8 of TGO 91. of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product does not meet the requirements of TGO 91 subsection 7(1) because the
container and primary pack do not bear a label that meets the requirements of
TGO 91.
Conditions imposed
The current registered Australian product label will be included in a clear
zip-lock bag containing one unit of the product, a 'Dear Healthcare
Professional' letter identical to that provided to the Therapeutic Goods
Administration on 27 October 2022 and a copy of the ONCASPAR Australian-approved
Product Information document.
Therapeutic product type
Prescription medicines