MAYZENT siponimod 0.25 mg film-coated tablet blister pack

Страна: Австралия

Език: английски

Източник: Department of Health (Therapeutic Goods Administration)

Активна съставка:

siponimod hemifumarate, Quantity: 0.278 mg (Equivalent: siponimod, Qty 0.25 mg)

Предлага се от:

Novartis Pharmaceuticals Australia Pty Ltd

Лекарствена форма:

Tablet, film coated

Композиция:

Excipient Ingredients: iron oxide black; titanium dioxide; lactose monohydrate; lecithin; crospovidone; polyvinyl alcohol; purified talc; colloidal anhydrous silica; glycerol dibehenate; microcrystalline cellulose; iron oxide red; xanthan gum

Начин на приложение:

Oral

Броя в опаковка:

12 tablets (titration pack), 120 tablets

Вид предписание :

(S4) Prescription Only Medicine

Терапевтични показания:

Mayzent is indicated for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS)

Каталог на резюме:

Visual Identification: Pale red, round, biconvex, beveled-edged film-coated tablet with Novartis logo on one side and T on other side; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Статус Оторизация:

Registered

Дата Оторизация:

2019-11-01

Листовка

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Данни за продукта

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