Tsis ntev los no, Chongqing Lemei Longyu Pharmaceutical Co., Ltd. ("Lemei Longyu"), lub tuam txhab tuav pov hwm ntawm Guangxi Wuzhou Zhongheng Group Co., Ltd.Daim Ntawv Ceeb Toom Pom Zoo rau Kev Lag Luam Daim Ntawv Thov Kev Siv Tshuaj Siv Tshuaj Muaj Tshuajrau Nicorandil (Specification: 4.00kg / hnab, 1 hnab / lub raj mis), uas tau pom zoo thiab muab los ntawm National Medical Products Administration (NMPA). Cov teeb meem cuam tshuam tau tshaj tawm raws li hauv qab no:
I. Cov ntaub ntawv tseem ceeb ntawm Nicorandil Active Pharmaceutical Ingredient
| Lub npe ntawm Tshuaj Active Pharmaceutical Ingredient |
Lub npe: Nicorandil Lus Askiv/Latin Lub Npe: Nicorandil |
| Ntim Specifications | 4.00kg / hnab, 1 hnab / lub raj mis |
| Daim Ntawv Ceeb Toom No. |
2024 XYOO 00170 |
| Registration Standard No. of Chemical Active Pharmaceutical Ingredient |
YWB 61952024 |
| Cov khoom siv | Daim ntawv thov kev lag luam rau hauv tsev - tsim tshuaj lom neeg cov khoom xyaw |
| Lub Sijhawm siv tau | 24 hli |
| Chaw tsim tshuaj paus |
Lub npe: Chongqing Lemei Longyu Pharmaceutical Co., Ltd. Chaw nyob: Tsis yog. 2, Huanan 4th ceg ntoo txoj kev, Economic thiab Technological Development Zone, Changshou District, Chongqing |
|
Kev pom zoo xaus |
Raws li txoj cai lij choj ntawm Kev Tswj Xyuas Tshuaj ntawm Cov Neeg Tuam Txhab Tuam Txhab Tuam Txhab thiab cov kev cai cuam tshuam, tom qab kev tshuaj xyuas, cov khoom no ua tau raws li qhov yuav tsum tau muaj rau kev sau npe tshuaj, thiab nws daim ntawv thov sau npe raug pom zoo. Cov txheej txheem tsim khoom, cov qauv zoo, thiab cov ntawv ntim khoom yuav tsum tau ua raws li cov ntaub ntawv txuas nrog. |
| Lub Sijhawm siv tau ntawm Daim Ntawv Ceeb Toom | Siv tau kom txog rau thaum Lub Ob Hlis 27, 2029 |
II. Lwm cov ntaub ntawv ntsig txog Nicorandil Active Pharmaceutical Ingredient
Nicorandil rau kev txhaj tshuaj feem ntau yog qhia rau qhov tsis ruaj khov angina pectoris thiab mob plawv tsis ua haujlwm. Nws txhim kho coronary microcirculation, txo cov xwm txheej ntawm cov hlab plawv, thiab txo qhov kev pheej hmoo ntawm tus mob coronary syndrome, ua rau muaj txiaj ntsig zoo rau cov neeg mob.
Nicorandil yog Ameslikas tsim los ntawm Chugai Pharmaceutical Co., Ltd. Nws cov ntsiav tshuaj thiab cov tshuaj txhaj tshuaj tau pom zoo rau kev lag luam los ntawm Pharmaceuticals thiab Medical Devices Agency (PMDA) ntawm Nyiv xyoo 1983 thiab 1993, feem. Thawj cov tshuaj tshawb fawb ntawm nicorandil ntsiav tshuaj tau pom zoo rau kev lag luam hauv Suav teb hauv xyoo 2005. Thaum Lemei Longyu tau thov daim ntawv thov rau nicorandil API lub sijhawm no, Chongqing Lummy Pharmaceutical Co., Ltd., uas yog tus tuav haujlwm ntawm Pab Pawg, kuj tau xa daim ntawv thov kev lag luam rau cov kev npaj ntawm cov khoom no rau National Medical Products Administration (NMPA).
