Elagolix 834153-87-6

Tsanangudzo Pfupi

Zita reAPI Indication Tsanangudzo US DMF EU DMF CEP
ElagolixCAS:834153-87-6 Endometriosis Mumba      


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PRODUCT DETAIL

Mushonga uyu unoshandiswa nevakadzi kubatsira kubvisa marwadzo ari pakati nepakati kusvika kune akanyanya nekuda kwechirwere chinonzi endometriosis.
Inogona Kurapa: Endometriosis
Mazita eBrand: Orilisa
Drug Kirasi: LHRH (GnRH) Vanopikisa
Kuwanika: Kunyorerwa Kunodiwa
Kubata pamuviri: Dzivisa kushandiswa panguva yekuzvitakura
Lactation: Bvunza chiremba usati washandisa

Elagolix ndeyemuromo bioavailable, yechipiri-chizvarwa, isiri-peptide yakavakirwa, diki molecule musanganiswa uye inosarudza gonadotropin-inoburitsa mahomoni (GnRH; LHRH) anopokana antagonist, ane angangoita mahormone ekugadzira inhibitory chiitiko. Pamusoro pekutonga nemuromo, elagolix inokwikwidza neGnRH yekugamuchira inosunga uye inovharidzira kusaina kweGnRH receptor mune anterior pituitary gland. Izvi zvinodzivisa kubudiswa kwe luteinizing hormone (LH) uye follicle stimulating hormone (FSH). Muvarume, kuvharirwa kweLH secretion kunodzivirira kusunungurwa kwe testosterone. Muvakadzi, kudziviswa kweFSH neLH kunodzivirira kubudiswa kweesrogen nemaovari. Kudzivirirwa kwechiratidzo cheGnRH kunogona kubata kana kudzivirira zviratidzo zvehomoni-inotsamira chirwere.

Elagolix ndeyemuromo, isiri-steroidal gonadotropin inoburitsa mahormone (GnRH) anopikisa iyo inoderedza kugadzirwa kweestrogen uye inoshandiswa kurapa nzira dzinorwadza dze endometriosis muvakadzi. Elagolix kurapa kwakabatana nehuwandu hwakaderera hweserum enzyme kukwidziridzwa panguva yekurapa uye haisati yave yakabatana nezviitiko zvekukuvara kwechiropa zvinooneka.

Elagolix yakashandiswa mumiedzo yekudzidza sainzi yekutanga uye kurapwa kweEndometriosis, Folliculogenesis, Uterine Fibroids, Kuyerera Kweropa Uterine Kunorema, uye Kubuda Kumwedzi Kwakanyanya. Kubva 24 Chikunguru 2018, zvakadaro, iyo US Chikafu neDrug Administration (FDA) yakabvumidza AbbVie's elagolix pasi pezita rechiratidzo Orilissa seyekutanga uye yega yemuromo gonadotropin-inoburitsa hormone (GnRH) antagonist yakanyatsogadzirirwa kuvakadzi vane mwero kusvika kunorwadza endometriosis. Izvo zvakatemwa kuti endometriosis ndeimwe yeakajairika gynecologic kusagadzikana muUnited States. Kunyanya, fungidziro dzinoratidza kuti mumwe muvakadzi gumi vezera rekubereka anobatwa neendometriosis uye anoona zviratidzo zvinorwadza zvinopedza simba. Uyezve, vakadzi vanobatwa nechirwere ichi vanogona kutambura kwemakore anosvika matanhatu kusvika kugumi uye kushanyira vanachiremba vakawanda vasati vawana kuongororwa kwakakodzera. Mushure mezvo, sekubvumidzwa kwaOrilissa (elagolix) neFDA pasi pekutariswa kwekutanga, iyi yakakurumidza kubvumidzwa kunopa vashandi vehutano imwe sarudzo yakakosha yekurapa zvingangove zvisingaite zvinodiwa nevakadzi vanobatwa neendometriosis, zvichienderana nerudzi rwavo uye kuoma kwemarwadzo eendometriosis. .

Chimiro chemakemikari

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

HUNHU MANAGEMENT

Hunhu manejimendi1

Proposal18Quality Consistency Evaluation mapurojekiti akatenderwa4,uye6mapurojekiti ari pasi pekubvumidzwa.

Hunhu manejimendi2

Yepamberi yepasirese yemhando manejimendi system yakaisa hwaro hwakasimba hwekutengesa.

Hunhu hutongi3

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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