ZOLGENSMA onasemnogene abeparvovec 2 x e13 vg/mL injection for intravenous infusion 8.3 mL vial, Novartis Pharmaceuticals Australia Pty Ltd, CON-1255
Product name
ZOLGENSMA onasemnogene abeparvovec 2 x e13 vg/mL injection for intravenous infusion 8.3 mL vial
Sponsor name
Novartis Pharmaceuticals Australia Pty Ltd
Consent start
Consent no.
CON-1255
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