Chengdu Shengnuo Biotechnology Co., Ltd. (tom qab no hu ua "Lub Tuam Txhab") tshaj tawm tias nws tag nrho -tus tswv lag luam, Chengdu Shengnuo Biopharmaceutical Co., Ltd., tsis ntev los no tau txais lubDaim Ntawv Ceeb Toom Pom Zoo rau Kev Lag Luam Daim Ntawv Thov Kev Siv Tshuaj Siv Tshuaj Siv Tshuajrau cetrorelix acetate API, muab los ntawm National Medical Products Administration (tom qab no hu ua "NMPA"). Cov ntsiab lus tseem ceeb tau tshaj tawm hauv qab no:
I. Cov Ntaub Ntawv Tseem Ceeb ntawm Cov Tshuaj
Sau npe No.: Y20220000342
Lub npe ntawm Chemical APITom ntej: Cetrorelix Acetate
Kev Sau Npe Tus Qauv No. of Chemical APIPIB: YBY61552024
Ntim Specification: 5g / fwj
Cov khoom siv: Daim ntawv thov kev lag luam rau hauv teb chaws - tsim tshuaj API
Chaw tsim tshuaj paus: Chengdu Shengnuo Biopharmaceutical Co., Ltd.
Kev pom zoo xaus: Raws li covTxoj Cai Tswj Tshuaj Txhaum Cai ntawm Tuam Txhab Tuam Txhab Suavthiab cov kev cai cuam tshuam, thaum tshuaj xyuas, cov khoom no ua raws li cov cai ntawm cov cai sau npe tshuaj cuam tshuam, thiab nws cov khoom tsim tau raug pom zoo los ntawm no. Cov txheej txheem zoo, cov ntawv ntim khoom thiab cov txheej txheem tsim khoom yuav tsum tau ua raws li cov ntaub ntawv txuas nrog.
II. Lwm cov ntaub ntawv ntawm Cov Tshuaj
Cetrorelix acetate yog ib qho hluavtaws decapeptide uas nws qhov kev npaj yog txhaj tshuaj gonadotropin - tso tawm cov tshuaj hormone (GnRH) antagonist, qhia rau kev pabcuam kev loj hlob thiab inhibition ntxov ntxov luteinizing hormone (LH) surge. Cov kev tshawb fawb tau pom tias cetrorelix acetate nthuav tawm cov txiaj ntsig zoo hauv kev kho mob xws li mob qog noj ntshav ntawm zes qe menyuam, mob qog noj ntshav prostate, uterine fibroids thiab endometriosis. Nws kuj muaj kev tiv thaiv zoo ntawm benign prostatic hyperplasia thiab zes qe menyuam hyperstimulation syndrome.
