??????????????�?????????????????????�(2015??117?)?????????????????????????????�?????????????????�(2015??197?)??,2015?10?26?�31?,??????????????????????????????????????????,??????????:
?????,???????????????????????????(???:CXHS1500028),?????????????????????(???:CYHS1390059?CYHS1390060),????????????????????(???:CYHS1390020),??????????????????????(???:CYHS1190072),????????????????????????(???:CXHS1190001),???????????????????????(???:CYHS1190129),??????????????????????????(???:CYHS1190061)???????(???:CYHS1190062),???????????????????(???:CYHS1190070)?????????(???:CYHS1290102)?11???????????????????????????????????????�????????�????,???11????????????
????????????????????????:
(?)????????(???:CXHS1500028),????????????????????,?????????????????,????????????????????????
1.?????????????????????????????????????????????????????????????????????????,?????????????;??????????????????????,?????????
2.????????????????23?????????????????,????????????????????20??
3.??????????????????????????????????????,????????????????
4.????????????????????????,??????????;???????????18???,????9???9??????????,????????????????
5.???????????????????????,????????????????????,????????????????????;8???????????????????????????????????,????????????????
6.??????????????????????,?????????????????;??????????????????
(?)??????(???:CYHS1390059?CYHS1390060),????????????????,?????????????????,????????????????????????
1.????????????????????????????????????????????????????????????????????,?????????????;??????????????????????,?????????
2.??????????????????????????????????????,????????????????
3.????????,???????????????????????????????????;??????????????,?????????
4.????????????30????????90?????????????????????,?????????,??????????????????????????????????????
5.????????????????????28???,????9???9??????????,???????????????;12??????????81?????,??????????????81????????,?????揅andesartan5181�???????
6.?????????3???????????????????????????????????,????????????????
7.??????????????????????,?????????????????,??????????????????
(?)???????(???:CYHS1390020),??????????????,???????????????????????????
1.?????????????????????????48????,????24?,????24?,??????????????????????????;????????????????
2.??????????????????(CRF),???????,?????????????????????????????
3.?????????????????????????????,????????????????????????????????????????????????????????,?????????????????:
(1)??????????????????2012?8?15?????????2012?7?4?,????????,??????11????????;2012?8?17?????????2012?7?4?,??????????,??????17?????????
(2)???????????????????2012?8?24?????????2012?8?16?,???????4??5???????,??4?????????????3?,5?????????????2?,??????????????????
(?)????????(???:CYHS1190072),???????????????,??????????????????????????,????????????????????
1.??????????????????,???????,????????????????????????????,???????????????�????�?????????????????,????????
2.????????????????????????,????????,???????
3.?????????????????????????????,?????????????????????????????????????????????:
(1)????????????????????????:2010?11?22?26?29?????????,2011?1?12?13?14?????????,2011?1?15?????????,1?20??????????????:2011?1?20????????????1?19?�20????????????,??1?19?????????????;1?20??????2011?1?12???????????
(2)2011?1?19???????,???16???????,??7????,??????1???????8??????????2011?1?26??2011?1?28???????,?????????????????,?????????????
(?)?????????(???:CXHS1190001),????????????????,??????????????????,???????????????????????????????
1.?????????????????????????????????????
2.????????????????(??????)?????????????32?????????;??????????????????31??????????????
3.?????????????,??????,????????????;????????????????????????;???????????????????;????????1????????????????????,????????;?????????????????
4.???????????4????187?????,??????????188?,???5?????�???�?????,?????????,????????�????,???�?
5.??????????????????????????,????????????
(?)??????????(???:CYHS1190129),??????????????,??????????????????,???????????????????????????????
1.?????????????????????????????????????
2.???????????32???????????????,??????????????????????????8??????12?????????????????
3.?????????????,??????,????????????,?????????;????????????????????????;?????????????????
4.??????????????????2010?4?�7?,????????????????2011?3?2?;??140?????,??2010?6?30?????????3??????????????????????
5.???????????????????????,??????????;??????????,??????DAS???????????????????,???????????????????????????,???????????????;????????????????,????????????
(?)???????(???:CYHS1190061),????????????????????,??????????????????
1.?????????????????????,20???????6?????????????????????;10?????????????????,????????????????????,??????????,??????????????????????????
2.??????????????????????????,????????????;????????????????10??,??????10??,???????????????5???
3.?????????????????????,?????????????,???????????,????????;?????????????????8??,???????????????????24???
4.?????????????,???????????????8??,??????????5?,?????7???5?,?????6???5??????(2010-12-02)?13???????,???????????6?,??????????????????????,????????,??????????????,???????
5.???????????????,2010?10?18???(09-25-51),?????????????09:25:51,?????19:47:46,?10?18???(12-18-36)?????12:18:36,?????????????????2010?10?20??10?21????????
(?)??????(???:CYHS1190062),????????????????????,??????????????????
1.?????????????????????;20????????17?????????????,11???????,???????????????????????;??????????;??????????????????????????
2.????????2010?11?15?????(BLF 2010-11-15 10-12-22),???????7??,??cal-1???????,???????????,???????,?cal-1??????????????,????????????;cal-2?cal-3??????2010?12?27???????????????????????,????,?????????????????
3.??????????2010?11?25??12?7??12?23?,???????????,????????;11?25??????????????,?????????;2010?11?15?�12?2?,???1260???,??????15??/??,?????15000mL,?????????????????9000mL?
4.?????????2010?11?22?????(13-03-48),?????????????13:03:49,?????11?23?06:45:08,?11?23???(3-42-09)?????03:42:12,????????????????????
(?)??????(???:CYHS1190070),??????????????,??????????????????????,??????????????????????
1.???????????????????,?????????????????;???????????????,???�?????????????�????????????????,???????????????;??????????????????????????; ????????????,????????
2.???????2008?�?????????????????�?????2008?8?????????,?2008?1???????????????;�????????????�?????????????�????????????�???????,????????????????
3.????????????????????????-????????,?????????????????????
(?)????????(???:CYHS1290102),??????????????,??????????????????????,??????????????????????
1.???????????????????,?????????????????;???????????????,???�?????????????�????????????????,???????????????;???????????????????????????
2.????????????26?,??20?, ??????�?????????????????????�??,????????????????,????20?????????,????6????????,???????6?????????;????????????????????,??????????,??????????????????????
3.??????????????????????,???????????????????,??????????????;???????????????????????????????????,??????????????
??????????????????,????????????????????????????????????????????????????????????,??????????????????????,???????????????;?????????????????????????????????????????????????????,????????????????????????????????????????????????,???????????????????????????????,?????????????????????,????????????????????????????
?????
????????
2015?11?11?