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 kunorwadza nekuda kwechirwere chinonzi endometriosis.
Inogona Kurapa: Endometriosis
Mazita Mazita: Orilisa
Kirasi yezvinodhaka: 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 mamorekuru musanganiswa uye inosarudza gonadotropin-inoburitsa mahormone (GnRH; LHRH) inopokana antagonist, ine inogona kuita mahormone inhibitory chiitiko.Pamusoro pekutonga nemuromo, elagolix inokwikwidza neGnRH yekubatanidza receptor uye inhibits GnRH receptor kusaina 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 kugadzirwa kweesrogen nemaovari.Kudzivirirwa kwechiratidzo cheGnRH kunogona kurapa kana kudzivirira zviratidzo zvehomoni-inotsamira chirwere.

Elagolix ndeyemuromo, isiri-steroidal gonadotropin inoburitsa mahomoni (GnRH) anopikisa iyo inoderedza kugadzirwa kweestrogen uye inoshandiswa kurapa maitiro anorwadza eendometriosis muvakadzi.Elagolix therapy inosanganiswa nehuwandu hwakaderera hweserum enzyme yakakwira panguva yekurapa uye haisati yave yakabatana nezviitiko zvekukuvara kwechiropa zvinooneka.

Elagolix yakashandiswa mumiyedzo yekudzidza sainzi yekutanga uye kurapwa kweEndometriosis, Folliculogenesis, Uterine Fibroids, Kuyerera Kweropa Uterine Kunorema, uye Kubuda Kuropa Kunyanya Kumwedzi.Kubva 24 Chikunguru 2018, zvisinei, iyo US Food and Drug Administration (FDA) yakabvumidza AbbVie's elagolix pasi pezita rechiratidzo Orilissa seyekutanga uye yega yemuromo gonadotropin-inoburitsa hormone (GnRH) antagonist yakanyatsogadzirirwa kuvakadzi vane pakati kusvika kunorwadza endometriosis.Zvakatemerwa kuti endometriosis ndeimwe yeakajairika gynecologic kusagadzikana muUnited States.Kunyanya, fungidziro dzinoratidza kuti mumwe muvakadzi gumi vezera rekubereka anobatwa neendometriosis uye anonzwa 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 yekuchimbidza mvumo nyowani inopa 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

Quality management1

Proposal18Quality Consistency Evaluation mapurojekiti akatenderwa4,uye6mapurojekiti ari pasi pekubvumidzwa.

Quality management2

Yepamberi yepasirese yemhando manejimendi system yakaisa hwaro hwakasimba hwekutengesa.

Quality management3

Kutariswa kwemhando yepamusoro kunofamba kuburikidza nehupenyu hwese kutenderera kwechigadzirwa kuti ive nechokwadi chemhando nekurapa.

Quality management4

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

KUTUNGAMIRIRA KWEKUGARA

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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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DCS Control Room

PARTNER

Kudyidzana kwenyika dzose
International cooperation
Kushandira pamwe kwemumba
Domestic cooperation

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