Ruxolitinib

Tsanangudzo Pfupi

Zita reAPI Indication Innovator Patent Expiry Date (The US)
Ruxolitinib Myelofibrosis Novartis Chikunguru. 6, 2024


Product Detail

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PRODUCT DETAIL

Ruxolitinib idiki molecule Janus kinase inhibitor iyo inoshandiswa mukurapa kwepakati kana yakanyanya njodzi myelofibrosis uye inodzivirira mafomu e polycythemia vera uye graft-vs-host chirwere. Ruxolitinib inosanganiswa nekukwira kwenguva pfupi uye kazhinji kunyoro mu serum aminotransferase panguva yekurapa uye kune zvisingawanzo zviitiko zvekuzvimiririra, zvinoratidzika sekiriniki idiosyncratic acute chiropa kukuvara pamwe chete nezviitiko zvekugadzirisazve hepatitis B muvanhu vanobatwa.

Ruxolitinib is an orally bioavailable Janus-associated kinase (JAK) inhibitor ine zvinogona antineoplastic uye immunomodulating zviitiko. Ruxolitinib inonyanya kusungira uye inhibits proteintyrosinekinases JAK 1 uye 2, izvo zvinogona kutungamirira kukudzikisira kwekuputika uye kudziviswa kwekuwedzera kwemasero. Iyo JAK-STAT (signal transducer uye activator of transcription) nzira inoita basa rinokosha pakuratidzwa kwema cytokines akawanda uye kukura kwezvinhu uye inobatanidzwa mukupararira kwemasero, kukura, hematopoiesis, uye maitiro ekudzivirira zvirwere; JAK kinases inogona kukwidziridzwa muzvirwere zvinoputika, myeloproliferative disorders, uye zvirwere zvakasiyana-siyana.

Ruxolitinib is apyrazoleinotsiviwa panzvimbo 1 neboka re2-cyano-1-cyclopentylethyl uye panzvimbo 3 neboka repyrrolo [2,3-d] pyrimidin-4-yl. Inoshandiswa semunyu wephosphate pakurapa varwere vane myelofibrosis yepakati kana yepamusoro, kusanganisira primary myelofibrosis, post-polycythemia vera myelofibrosis uye post-essential thrombocythemia myelofibrosis. Iine basa seantineoplastic agent uye EC 2.7.10.2 (isina-specific protein-tyrosinekinase) inhibitor. Iyo nitrile, apyrrolopyrimidineuye nhengo yepyrazoles.

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

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Hunhu manejimendi1

Proposal18Quality Consistency Evaluation mapurojekiti akatenderwa4,uye6mapurojekiti ari pasi pekubvumidzwa.

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Yepamberi yepasirese yemhando manejimendi system yakaisa hwaro hwakasimba hwekutengesa.

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Kutariswa kwemhando yepamusoro kunomhanya kuburikidza nehupenyu hwese kutenderera kwechigadzirwa kuti ive nechokwadi chemhando uye yekurapa maitiro.

Hunhu manejimendi4

Professional Regulatory Affairs timu inotsigira zvinodiwa zvemhando panguva yekushandisa uye kunyoreswa.

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Kudyidzana kwenyika dzakawanda
Kudyidzana kwenyika dzakawanda
Kushandira pamwe kwemumba
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