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).
Kapezekedwe: Dongosolo Lofunika
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 inhibitory ntchito.Pakamwa, elagolix imapikisana ndi GnRH pomanga ma receptor ndikuletsa ma GnRH receptor signing 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, kulepheretsa 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) omwe amachepetsa kupanga kwa estrogen ndipo amagwiritsidwa ntchito pochiza mitundu yowawa ya endometriosis mwa amayi.Thandizo la Elagolix limalumikizidwa ndi kutsika kotsika kwa ma enzymes a seramu panthawi yamankhwala ndipo sikunaphatikizidwebe ndi zochitika zakuvulala kwachiwindi komwe kumawonekera.

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 yekha 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 zomwe zimafala 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 ndikupita kwa madokotala angapo asanawazindikire bwinobwino.Pambuyo pake, monga Orilissa (elagolix) adavomerezedwa ndi FDA mowunikiridwa patsogolo, kuvomerezedwa kwatsopano kumeneku kumapatsa akatswiri azaumoyo njira ina yofunika yochizira zomwe mwina sizingakwaniritsidwe za amayi omwe akhudzidwa ndi endometriosis, kutengera mtundu wawo komanso kuopsa kwa ululu wa endometriosis. .

Kapangidwe ka mankhwala

dsfs

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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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
International cooperation
Mgwirizano wapakhomo
Domestic cooperation

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