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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-766

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-766
Duration
The consent for Therapeutic Goods Order No. 91 is effective for three years from 24 February 2021. The consent for Therapeutic Goods Order No 100 Section 9(a) is effective for product supplied from 24 February 2021 until 31 July 2021.
Standard
Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines and Therapeutic Goods Order No. 100 - Microbiological Standards for Medicines
Non-compliance with standard
The product label does not comply with the TGO 91 regarding the following information Section 8(1)(c) and Section 10(4)(e) the quantity or proportion of the active ingredient in the medicine is not presented on vials Section 8(1)(e) and Section 10(4)(g) quantity of the medicine not stated on vials or carton.Section 8(1)(i) and Section 10(4)(j) 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.Section 9(1)(e) The quantity of the medicine (number of containers) is not on the main label of the carton.Section 10(4)(d) the name(s) of all active ingredients in the medicine is incorrect on the vial.Section 10(4)(f) the name of the dosage form is incorrect on the vial.Section 11(3)(a) The potency of the biological is missing from the vial label. And Therapeutic Goods Order No. 100 - Microbiological Standards for Medicines- Section 9(a) the sampling schedule does not comply with the Test for Sterility of a default standard.
Conditions imposed
          ‚ÄčThere 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

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