Elagolix 834153-87-6

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Igama le-API Isalathiso Inkcazo USDMF EU DMF CEP
ElagolixI-CAS:834153-87-6 Endometriosis Endlwini      


Iinkcukacha zeMveliso

Iithegi zeMveliso

IINKCUKACHA ZEMVELISO

Eli yeza lisetyenziswa ngabasetyhini ukunceda ukuthomalalisa okuphakathi ukuya kwiintlungu ezinzima ngenxa yemeko ebizwa ngokuba yi-endometriosis.
Ngamana Ukunyanga: Endometriosis
Amagama eBrand: Orilissa
Udidi lweziyobisi: LHRH (GnRH) Abachasi
Ukufumaneka: Umyalelo ofunekayo
Ukukhulelwa: Kuphephe ukusebenzisa ngexesha lokukhulelwa
Ukuncancisa: Dibana nogqirha phambi kokuba usebenzise

I-Elagolix i-bioavailable yomlomo, isizukulwana sesibini, i-non-peptide esekelwe, i-molecule encinci ye-molecule kunye ne-hormone ekhethiweyo ye-gonadotropin-releasing (GnRH; LHRH) ye-receptor antagonist, kunye nomsebenzi onokuthi unqande ukuveliswa kwehomoni.Ekulawuleni komlomo, i-elagolix ikhuphisana ne-GnRH yokubopha i-receptor kwaye inqanda ukubonakaliswa kwe-GnRH ye-receptor kwi-anterior pituitary gland.Oku kuthintela ukukhutshwa kwehomoni ye-luteinizing (LH) kunye ne-follicle stimulating hormone (FSH).Kwamadoda, ukuvinjelwa kwe-LH secretion kuthintela ukukhululwa kwe testosterone.Kwabasetyhini, ukuvinjelwa kwe-FSH kunye ne-LH kuthintela ukuveliswa kwe-estrogen ngama-ovari.Ukuvinjwa kokubonakaliswa kwe-GnRH kunokunyanga okanye kuthintele iimpawu zesifo esixhomekeke kwihomoni yesini.

I-Elagolix sisichasi somlomo, esingekho steroidal se-gonadotropin esikhupha ihomoni (GnRH) eyehlisa imveliso ye-estrogen kwaye isetyenziselwa ukunyanga iindlela ezibuhlungu ze-endometriosis kwabasetyhini.Unyango lwe-Elagolix lunxulunyaniswa nezinga eliphantsi lokunyuka kwe-serum enzyme ngexesha lonyango kwaye kusafuneka inxulunyaniswe neemeko zokwenzakala kwesibindi okubonakalayo.

I-Elagolix isetyenziswe kuvavanyo lokufunda isayensi esisiseko kunye nonyango lwe-Endometriosis, i-Folliculogenesis, i-Uterine Fibroids, ukopha kakhulu kwesibeleko, kunye nokopha kakhulu exesheni.Ukusukela nge-24 kaJulayi ka-2018, nangona kunjalo, i-US Food and Drug Administration (FDA) yavuma i-elagolix ye-AbbVie phantsi kwegama lebrendi i-Orilissa njengendawo yokuqala kunye nekuphela kwehomoni yomlomo ekhupha i-gonadotropin (GnRH) ephuhliswe ngokukodwa kubasetyhini abaneentlungu eziphakathi ukuya kweziqatha ze-endometriosis.Kuye kwafunyaniswa ukuba i-endometriosis yenye yeengxaki eziqhelekileyo ze-gynecologic e-United States.Ngokukodwa, uqikelelo lucebisa ukuba omnye kwabasetyhini abalishumi abakwiminyaka yokuzala uchatshazelwa yi-endometriosis kwaye abe namava eentlungu ezidambisayo.Ngaphezu koko, abasetyhini abachatshazelwa yile meko banokubandezeleka ukuya kutsho kwiminyaka emithandathu ukuya kwelishumi kwaye batyelele oogqirha abaninzi ngaphambi kokuba bafumane ukuxilongwa ngokufanelekileyo.Emva koko, njengoko u-Orilissa (elagolix) wamkelwa yi-FDA phantsi kophononongo oluphambili, le mvume ikhawulezileyo entsha inika abaqeqeshi bezempilo olunye ukhetho oluxabisekileyo lokunyanga iimfuno ezinokuthi zingafezekiswa zabasetyhini abachatshazelwe yi-endometriosis, ngokuxhomekeke kuhlobo lwabo oluthile kunye nobukhulu bentlungu ye-endometriosis. .

Ubume beMichiza

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ISIQINISEKISO

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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