Ruxolitinib

Kufotokozera Kwachidule:

Dzina la API Chizindikiro Woyambitsa Tsiku Lomaliza Ntchito (The US)
Ruxolitinib Myelofibrosis Novartis Jul. 6, 2024


Tsatanetsatane wa Zamalonda

Zolemba Zamalonda

PRODUCT DETAIL

Ruxolitinib ndi molekyu yaing'ono Janus kinase inhibitor yomwe imagwiritsidwa ntchito pochiza myelofibrosis yapakatikati kapena yowopsa komanso yolimbana ndi polycythemia vera ndi matenda a graft-vs-host. Ruxolitinib imalumikizidwa ndi kukwera kwapang'onopang'ono kwa seramu aminotransferase panthawi ya chithandizo komanso nthawi zambiri za kuvulala koopsa kwachiwindi, komwe kumawonekera mwachidziwitso komanso kuyambiranso kwa chiwindi cha B mwa anthu omwe ali pachiwopsezo.

Ruxolitinib ndi janus-associated kinase (JAK) inhibitor yomwe imapezeka pakamwa ndi bioavailable yomwe ingathe kuchitapo kanthu kuti iwononge chitetezo cha mthupi. Ruxolitinib imamangiriza ndikuletsa mapulotenityrosinekinases JAK 1 ndi 2, zomwe zingayambitse kuchepa kwa kutupa ndi kulepheretsa kuchuluka kwa ma cell. Njira ya JAK-STAT (signal transducer ndi activator of transcript) imagwira ntchito yofunika kwambiri pakuzindikiritsa ma cytokines ambiri ndi zinthu zakukula ndipo imakhudzidwa ndi kuchuluka kwa ma cell, kukula, hematopoiesis, ndi chitetezo chamthupi; JAK kinase ikhoza kuyendetsedwa ndi matenda otupa, matenda a myeloproliferative, ndi zilonda zosiyanasiyana.

Ruxolitinib ndipyrazolekulowetsedwa pa malo 1 ndi gulu la 2-cyano-1-cyclopentylethyl ndi pa malo 3 ndi gulu la pyrrolo [2,3-d] pyrimidin-4-yl. Ntchito monga mankwala mchere zochizira odwala wapakatikati kapena chiopsezo myelofibrosis, kuphatikizapo chachikulu myelofibrosis, pambuyo polycythemia vera myelofibrosis ndi pambuyo zofunika thrombocythemia myelofibrosis. Ili ndi ntchito ngati antitineoplastic agent ndi EC 2.7.10.2 (mapuloteni omwe si enieni-tyrosinekinase) inhibitor. Ndi nitrile, apyrrolopyrimidinendi membala wa pyrazoles.

CERTIFICATE

2018 GMP-2
原料药GMP证书201811 (captopril,thalidomide etc)
GMP-of-PMDA-in-Chanyoo-平成28年08月03日 Nantong-Chanyoo-Pharmatech-Co
FDA-EIR-Letter-201901

KUSINTHA KWA KHALIDWE

Kasamalidwe kabwino 1

Malingaliro18Ma projekiti a Quality Consistency Evaluation omwe avomereza4,ndi6mapulojekiti akuvomerezedwa.

Kasamalidwe kabwino2

Dongosolo lotsogola lapadziko lonse lapansi loyang'anira bwino layala maziko olimba pakugulitsa.

Kasamalidwe kabwino3

Kuyang'anira kwabwino kumayendera nthawi yonse ya moyo wa chinthucho kuti zitsimikizire kuti zikuyenda bwino komanso zochiritsira.

Kasamalidwe kabwino4

Gulu la Professional Regulatory Affairs limathandizira zofunikira pakufunsira ndikulembetsa.

MANAGEMENT ZOPHUNZITSA

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Taiwan CVC Bottled Packaging Line

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Italy CAM Board Packaging Line

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Japan Viswill Tablet Detector

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WOTHANDIZA

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Mgwirizano wapadziko lonse lapansi
Mgwirizano wapakhomo
Mgwirizano wapakhomo

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