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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
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
-The quantity or proportion of the active ingredient in the medicine is not presented on vials
-The quantity of the medicine is not stated on vials or carton
-The name of the sponsor or distributor, as it appears on the primary pack or registered trademark if it readily identifies the Sponsor or distributor of the medicine, is absent from the vial.
-The quantity of the medicine (number of containers) is not on the main label of the carton
-The name(s) of all active ingredients in the medicine is incorrect on the vial
-The name of the dosage form is incorrect on the vial.
-The potency of the biological is missing from the vial label
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.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines