Tsis ntev los no, Baiyunshan Chemical Pharmaceutical Factory, ib ceg ntawm Guangzhou Baiyunshan Pharmaceutical Holdings Co., Ltd.Daim Ntawv Pom Zoo Pom Zoo rau Kev Lag Luam Daim Ntawv Thov ntawm Tenofovir Alafenamide Fumarate Active Pharmaceutical Ingredient, uas tau raug txheeb xyuas thiab muab los ntawm National Medical Products Administration (NMPA). Cov ntsiab lus tseem ceeb tau tshaj tawm hauv qab no:
I. Cov Ntaub Ntawv Tseem Ceeb ntawm Cov Tshuaj
Lub npe ntawm cov tshuaj nquag siv tshuajTom ntej: Tenofovir Alafenamide Fumarate
Ntim SpecificationsNtim: 10kg / nruas, 15kg / nruas, 20kg / nruas, 25kg / nruas
Daim Ntawv Ceeb Toom Pom Zoo: 2024YS00139
Txais Tus Naj NpawbPIB: CYHS2260041
Daim Ntawv Teev Npe Tus Qauv ntawm Cov Khoom Siv Tshuaj Muaj ZogPIB: YBY61632024
Lub Sijhawm siv tauib: 36ay
Chaw tsim tshuaj paus: Baiyunshan Chemical Pharmaceutical Factory ntawm Guangzhou Baiyunshan Pharmaceutical Holdings Co., Ltd.
Chaw Nyob Chaw Tsim Khoom: Tsis yog. 78 Tongbao Road, Tonghe Street, Baiyun District, Guangzhou
Lub Sijhawm Muaj Peev Xwm ntawm Daim Ntawv Pom Zoo Pom Zoo: Txog Lub Ob Hlis 26, 2029
Cov khoom siv: Daim ntawv thov kev lag luam rau cov khoom siv tshuaj hauv tsev
Kev pom zoo xaus: Raws li covTxoj Cai Tswj Tshuaj Txhaum Cai ntawm Cov Neeg Sawv Cev ntawm Tuam Tshojthiab cov kev cai cuam tshuam, thaum tshuaj xyuas, cov khoom no ua tau raws li cov kev cai rau kev sau npe tshuaj thiab raug pom zoo rau kev tsim khoom.
II. Lwm Cov Ntaub Ntawv Tseem Ceeb ntawm Cov Tshuaj
Tenofovir Alafenamide Fumarate yog ib qho tshuaj tiv thaiv kab mob siab B (HBV). Nws tau pom zoo rau kev lag luam los ntawm US Food and Drug Administration (FDA) thaum lub Kaum Ib Hlis 2017 raws li lub npe lag luamVemlidy, rau kev kho mob ntawm cov neeg mob uas muaj tus kab mob siab B mob ntev nrog rau cov kab mob siab rau lub siab.
