Երկիր: Ավստրալիա
Լեզու: անգլերեն
Աղբյուրը: Department of Health (Therapeutic Goods Administration)
sotrovimab, Quantity: 500 mg
GlaxoSmithKline Australia Pty Ltd
Injection, concentrated
Excipient Ingredients: water for injections; histidine hydrochloride monohydrate; histidine; polysorbate 80; methionine; sucrose
Intravenous Infusion
1 vial
(S4) Prescription Only Medicine
XEVUDY has provisional approval for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with coronavirus disease 2019 (COVID-19) who do not require initiation of oxygen due to COVID-19 and who are at increased risk of progression to hospitalisation or death (see Section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical Trials).,The decision has been made on the basis of short term efficacy and safety data. Continued approval of this indication depends on the evidence of longer term efficacy and safety from ongoing clinical trials and post-market assessment.
Visual Identification: a clear, colourless or yellow to brown concentrated injection solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Child resistant closure
Registered (Provisional)
2021-08-20
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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 Կարդացեք ամբողջական փաստաթուղթը