Elagolix 834153-87-6

Kufotokozera Kwachidule:

Dzina la API Chizindikiro Kufotokozera US DMF EU DMF CEP
ElagolixCAS:834153-87-6 Endometriosis M'nyumba      


Tsatanetsatane wa Zamalonda

Zolemba Zamalonda

PRODUCT DETAIL

Mankhwalawa amagwiritsidwa ntchito ndi amayi kuti athetse ululu wochepa kapena woopsa chifukwa cha matenda otchedwa endometriosis.
Chithandizo: Endometriosis
Dzina la Brand: Orilissa
Gulu la Mankhwala Osokoneza Bongo: Otsutsa a LHRH (GnRH).
Kupezeka: Zolemba Zofunika
Mimba: Pewani kugwiritsa ntchito pa nthawi ya mimba
Kuyamwitsa: Funsani dokotala musanagwiritse ntchito

Elagolix ndi pakamwa bioavailable, wa m'badwo wachiwiri, sanali peptide zochokera, kakang'ono kamolekyu pawiri ndi kusankha gonadotropin-release hormone (GnRH; LHRH) receptor antagonist, ndi zotheka kupanga mahomoni choletsa ntchito. Pakamwa, elagolix imapikisana ndi GnRH pomanga ma receptor ndikuletsa chizindikiro cha GnRH cholandilira mu anterior pituitary gland. Izi zimalepheretsa kutulutsa kwa luteinizing hormone (LH) ndi follicle stimulating hormone (FSH). Mwa amuna, kuletsa kwa LH secretion kumalepheretsa kutulutsidwa kwa testosterone. Kwa amayi, kuletsa kwa FSH ndi LH kumalepheretsa kupanga estrogen ndi mazira. Kuletsa chizindikiro cha GnRH kumatha kuchiza kapena kupewa zizindikiro za matenda omwe amadalira mahomoni ogonana.

Elagolix ndi oral, nonsteroidal gonadotropin release hormone (GnRH) yomwe imachepetsa kupanga estrogen ndipo imagwiritsidwa ntchito pochiza mitundu yowawa ya endometriosis mwa amayi. Thandizo la Elagolix limalumikizidwa ndi kuchepa kwa kuchuluka kwa ma enzymes a seramu panthawi ya chithandizo ndipo sikunagwirizanebe ndi zochitika zachipatala zowoneka bwino za kuvulala kwa chiwindi.

Elagolix yakhala ikugwiritsidwa ntchito m'mayesero ophunzirira sayansi yoyambira ndi chithandizo cha Endometriosis, Folliculogenesis, Uterine Fibroids, Kutaya Kwambiri kwa Uterine, ndi Kutaya Kwambiri Msambo. Pofika pa 24 Julayi 2018, komabe, US Food and Drug Administration (FDA) idavomereza elagolix ya AbbVie pansi pa dzina la Orilissa ngati mdani woyamba komanso wokhawo wapakamwa wotulutsa gonadotropin-release hormone (GnRH) wopangidwa makamaka kwa amayi omwe ali ndi ululu wocheperako mpaka wowawa kwambiri wa endometriosis. Zatsimikiziridwa kuti endometriosis ndi imodzi mwazovuta zachikazi zofala kwambiri ku United States. Makamaka, kuyerekezera kumasonyeza kuti mmodzi mwa amayi khumi a msinkhu wobereka amakhudzidwa ndi endometriosis ndipo amakumana ndi zizindikiro zowawa. Komanso, amayi omwe amakhudzidwa ndi matendawa amatha kuvutika kwa zaka zisanu ndi chimodzi kapena khumi ndipo amapita kwa madokotala angapo asanawadziwe bwino. Pambuyo pake, monga Orilissa (elagolix) adavomerezedwa ndi FDA mowunikiridwa patsogolo, kuvomerezedwa kwatsopano kumeneku kumapatsa akatswiri azaumoyo njira ina yofunikira yochizira zomwe mwina sizingakwaniritsidwe za amayi omwe akukhudzidwa ndi endometriosis, kutengera mtundu wawo komanso kuopsa kwa ululu wa endometriosis. .

Kapangidwe ka mankhwala

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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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Korea Countec Bottled Packaging Line

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Taiwan CVC Bottled Packaging Line

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Italy CAM Board Packaging Line

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German Fette Compacting Machine

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Japan Viswill Tablet Detector

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Chipinda chowongolera cha DCS

WOTHANDIZA

Mgwirizano wapadziko lonse lapansi
Mgwirizano wapadziko lonse lapansi
Mgwirizano wapakhomo
Mgwirizano wapakhomo

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