ZOLGENSMA onasemnogene abeparvovec 2 x e13 vg/mL injection for intravenous infusion 8.3 mL vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

onasemnogene abeparvovec, Quantity: 1 U

Available from:

Novartis Pharmaceuticals Australia Pty Ltd

Pharmaceutical form:

Injection, intravenous infusion

Composition:

Excipient Ingredients: sodium chloride; poloxamer; magnesium chloride hexahydrate; water for injections; hydrochloric acid; trometamol

Administration route:

Intravenous

Units in package:

2 vials of 8.3 mL each, 5 vials of 8.3 mL each, 9 vials of 8.3 mL each, 4 vials of 8.3 mL each, 6 vials of 8.3 mL each, 3 vials of 8.3 mL each, 7 vials of 8.3 mL each, 8 vials of 8.3 mL each

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ZOLGENSMA (onasemnogene abeparvovec) is indicated for the treatment of paediatric patients less than 9 months of age with symptomatic or pre-symptomatic spinal muscular atrophy with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene and 1 to 3 copies of the SMN2 gene.

Product summary:

Visual Identification: When thawed, the vial contents are clear to slightly opaque, colourless to faint white solution.; Container Type: Vial; Container Material: Other composite material; Container Life Time: 12 Months; Container Temperature: Store between minus 60 - minus 80 degrees; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2021-03-04

Patient Information leaflet

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Summary of Product characteristics

Product and Consumer Medicine Information Licence
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ACCESS TERMS FOR PRODUCT INFORMATION AND CONSUMER MEDICINE INFORMATION
DOCUMENTS ("LICENCE")
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YOU or YOUR means any legal person or entity who accesses or downloads
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US, WE or OUR means the COMMONWEALTH OF AUSTRALIA as represented by
the THERAPEUTIC GOODS ADMINISTRATION ABN 40 939 406 804 of 136
Narrabundah Lane, Symonston ACT 2609, Australia.
OPERATIVE PROVISIONS *
NATURE OF AGREEMENT *
1.1  This Licence specifies the terms and conditions of Your access
and use of PI Documents and CMI Documents made available to the
general public by Us via Our website. *
1.2  You acknowledge and agree that accessing PI Documents or CMI
Documents in accordance with this Licence is beneficial to You because
it provides You with product information about therapeutic goods and
is beneficial to Us because it assists Us in our portfolio
responsibilities. *
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