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 kamolekyu 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 imayenderana ndi kukwera kwapang'onopang'ono kwa seramu ya aminotransferase panthawi ya chithandizo komanso nthawi zambiri za kuvulala koopsa kwachiwindi komwe kumawonekera modzidzimutsa komanso kuyambiranso kwa chiwindi cha B mwa anthu omwe atengeka.

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 kufalikira kwa ma cellular.Njira ya JAK-STAT (signal transducer ndi activator of transcription) 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 gawo ngati antineoplastic 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

Quality management1

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

Quality management2

Njira zotsogola zapadziko lonse lapansi zoyendetsera bwino zakhazikitsa maziko olimba pakugulitsa.

Quality management3

Kuyang'anira kwabwino kumayendera nthawi yonse ya moyo wa chinthucho kuti zitsimikizire kuti zabwino ndi zochiritsira.

Quality management4

Gulu la Professional Regulatory Affairs limathandizira zofunikira pakufunsira ndikulembetsa.

MANAGEMENT ZOPHUNZITSA

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WOTHANDIZA

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International cooperation
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