Kesimpta-Ofatumumab 20 mg/0.4mL solution for injection pre-filled pen

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Ofatumumab, Quantity: 50 mg/mL

Available from:

Novartis Pharmaceuticals Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: arginine; sodium acetate trihydrate; sodium chloride; polysorbate 80; disodium edetate; hydrochloric acid; water for injections

Administration route:

Subcutaneous

Units in package:

1

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Kesimpta is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) to delay the progression of physical disability and reduce the frequency of relapse (refer to section 5.1).

Product summary:

Visual Identification: clear to slightly opalescent, colourless to slightly brownish-yellow,solution for injection; Container Type: Syringe; Container Material: Glass; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2021-03-04

Patient Information leaflet

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Summary of Product characteristics

Product and Consumer Medicine Information Licence
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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,
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