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

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

有效成分:

onasemnogene abeparvovec, Quantity: 1 U

可用日期:

Novartis Pharmaceuticals Australia Pty Ltd

药物剂型:

Injection, intravenous infusion

组成:

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

给药途径:

Intravenous

每包单位数:

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

处方类型:

(S4) Prescription Only Medicine

疗效迹象:

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.

產品總結:

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

授权状态:

Registered

授权日期:

2021-03-04

资料单张

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

产品特点

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