Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
onasemnogene abeparvovec, Quantity: 1 U
Novartis Pharmaceuticals Australia Pty Ltd
Injection, intravenous infusion
Excipient Ingredients: magnesium chloride hexahydrate; water for injections; sodium chloride; poloxamer; hydrochloric acid; trometamol
Intravenous
1 vial of 5.5 mL and 2 vials of 8.3 mL, 2 vials of 5.5 mL and 2 vials of 8.3 mL, 1 vial of 5.5 mL and 7 vials of 8.3 mL, 1 vial of 5.5 mL and 4 vials of 8.3 mL, 1 vial of 5.5 mL and 5 vials of 8.3 mL, 1 vial of 5.5 mL and 8 vials of 8.3 mL, 2 vials of 5.5 mL and 6 vials of 8.3 mL, 2 vials of 5.5 mL and 7 vials of 8.3 mL, 2 vials of 5.5 mL and 4 vials of 8.3 mL, 2 vials of 5.5 mL and 5 vials of 8.3 mL, 2 vials of 5.5 mL and 1 vial of 8.3 mL, 1 vial of 5.5 mL and 3 vials of 8.3 mL, 2 vials of 5.5 mL and 3 vials of 8.3 mL, 1 vial of 5.5 mL and 6 vials of 8.3 mL
(S4) Prescription Only Medicine
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.
Visual Identification: When thawed, the vial contents are clear to slightly opaque, colourless to faint white solution.; Container Type: Multiple containers; Container Material: Other composite material; Container Life Time: 12 Months; Container Temperature: Store between minus 60 - minus 80 degrees; Container Closure: Child resistant closure
Registered
2021-03-04
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Product and Consumer Medicine Information Licence ------------------------- ACCESS TERMS FOR PRODUCT INFORMATION AND CONSUMER MEDICINE INFORMATION DOCUMENTS ("LICENCE") PARTIES YOU or YOUR means any legal person or entity who accesses or downloads a PI Document or CMI Document from Our website and 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. * TERMS OF ACCESS * 2.1 We grant to You a perpetual, non-exclusive, royalty-free, world-wide, irrevocable and non-transferable licence to download, store in cache, display, print and copy a single copy or part of a single copy of a PI Document or CMI Document made available via Our website. * 2.2 If You wish to use any PI Document or CMI Document for purposes other than those specified in clause 2.1 of this Licence, You must seek the permission of the Sponsor. * 2.3 We may remove a PI Document or CMI Document from Our website at any time in Our sole discretion. * EXCLUSION OF LIABILITY * 3.1 You acknowledge and agree that You are responsible for making Your own enquiries to determine whether any PI Document or CMI Document is accurate, up to date and fit for Your purposes. * 3.2 The PI Document or CMI Document is provided to You for the purpose of disseminating health information free of charge for the benefit of the public. This Licence and any PI Document or CMI Document made available to You via Our website is not a substitute fo Read the complete document