PEMAZYRE pemigatinib 4.5 mg tablet blister pack

দেশ: অস্ট্রেলিয়া

ভাষা: ইংরেজি

সূত্র: Department of Health (Therapeutic Goods Administration)

সক্রিয় উপাদান:

pemigatinib, Quantity: 4.5 mg

থেকে পাওয়া:

Specialised Therapeutics Alim Pty Ltd

ফার্মাসিউটিকাল ফর্ম:

Tablet

রচনা:

Excipient Ingredients: microcrystalline cellulose; magnesium stearate; sodium starch glycollate type A

প্রশাসন রুট:

Oral

প্যাকেজ ইউনিট:

28, 14

প্রেসক্রিপশন টাইপ:

(S4) Prescription Only Medicine

থেরাপিউটিক ইঙ্গিত:

Pemigatinib has provisional approval in Australia for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that has progressed after at least one prior line of systemic therapy. 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).

পণ্য সারাংশ:

Visual Identification: Round shaped (5.8 mm diameter) white to off-white tablet, debossed with I on one side and with 4.5 on the other side.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 48 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

অনুমোদন অবস্থা:

Registered (Provisional)

অনুমোদন তারিখ:

2022-09-14

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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
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