TEPMETKO tepotinib 225 mg (as hydrochloride monohydrate) tablet blister pack

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

tepotinib hydrochloride monohydrate, Quantity: 250 mg (Equivalent: tepotinib, Qty 225 mg)

Disponibil de la:

Merck Healthcare Pty Ltd

Forma farmaceutică:

Tablet, film coated

Compoziție:

Excipient Ingredients: mannitol; crospovidone; magnesium stearate; colloidal anhydrous silica; hypromellose; titanium dioxide; lactose monohydrate; macrogol 3350; triacetin; iron oxide red; microcrystalline cellulose

Calea de administrare:

Oral

Unități în pachet:

60

Tip de prescriptie medicala:

(S4) Prescription Only Medicine

Indicații terapeutice:

TEPMETKO has provisional approval in Australia for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.,The decision to approve this indication has been made on the basis of overall response rate (ORR) and duration of response (DOR). Continued approval of this indication depends on verification and description of benefit in confirmatory trial(s).

Rezumat produs:

Visual Identification: White-pink, oval, biconvex film-coated tablet with embossment "M" on one side and plain on the other side.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 30 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Statutul autorizaţiei:

Registered (Provisional)

Data de autorizare:

2022-01-17

Prospect

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Caracteristicilor produsului

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. *
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Your own enquiries to determine whether any PI Document or CMI
Document is accurate, up to date and fit for Your purposes. *
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purpose of disseminating health information free of charge for the
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Document made available to You via Our website is not a substitute fo