VEKLURY remdesivir 100 mg powder for injection vial

Ülke: Avustralya

Dil: İngilizce

Kaynak: Department of Health (Therapeutic Goods Administration)

Aktif bileşen:

remdesivir, Quantity: 100 mg

Mevcut itibaren:

Gilead Sciences Pty Ltd

Farmasötik formu:

Injection, powder for

Kompozisyon:

Excipient Ingredients: sulfobutyl betadex sodium; sodium hydroxide; hydrochloric acid

Uygulama yolu:

Intravenous Infusion

Paketteki üniteler:

1 vial

Reçete türü:

(S4) Prescription Only Medicine

Terapötik endikasyonlar:

VEKLURY has provisional approval for the treatment of coronavirus disease 2019 (COVID-19) in:,- adults and paediatric patients (at least 4 weeks of age and weighing at least 3 kg) who have pneumonia due to SARS-CoV-2, and who require supplemental oxygen.,- adults and paediatric patients (weighing at least 40 kg) who do not require supplemental oxygen and who are at high risk of progressing to severe COVID-19.,The decision to approve this medicine has been made based on limited data. More comprehensive evidence is required to be submitted.

Ürün özeti:

Visual Identification: white to off-white to yellow lyophilized solid; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Yetkilendirme durumu:

Registered (Provisional)

Yetkilendirme tarihi:

2020-07-10

Bilgilendirme broşürü

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Ürün özellikleri

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