The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
ZOLGENSMA onasemnogene abeparvovec 2 x e13 vg/mL injection for intravenous infusion 5.5 mL vial, Novartis Pharmaceuticals Australia Pty Ltd, CON-1255
Product name
ZOLGENSMA onasemnogene abeparvovec 2 x e13 vg/mL injection for intravenous infusion 5.5 mL vial
Sponsor name
Novartis Pharmaceuticals Australia Pty Ltd
Consent start
Consent no.
CON-1255
Duration
The consent is effective from 11 July 2024 until 30 September 2026.
Standard
Paragraph 8(1)(c), 10(4)(e), 8(1)(e), 10(4)(g), 8(1)(i), 10(4)(j), 9(1)(e), and 10(4)(d) ,10(4)(f) and 11(3)(a) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
#NAME?
Conditions imposed
There will be a variable sticker for placement on the carton sleeve which
includes the number and strength of vials within the carton, the batch number
and expiry of the products and a machine-readable code.
Therapeutic product type
Prescription medicines