·|¡@¡@°T Á`´Á¼Æ¡G²Ä848´Á 2016¦~²Ä043´Á(105.10.31~105.11.04)~CAPA·|°T¤U¸ü~ ¥»¤½·|q©ó105¦~12¦~6¤ë(¤G)¤U¤È13¡G00-17¡G00°²±iºaµo°òª÷·|°ê»Ú·|ij¤¤¤ß801·|ij«Ç(¥x¥_¥«¤¤¥¿°Ï¤¤¤s«n¸ô11¸¹)¡AÁ|¦æ¡u²Ä¤»©¡²Ä¤T¦¸·|û¥Nªí¤j·|¡v¡AÅwªï·|û¥Nªí¿ãÅD°Ñ¥[¡C
2. ½Ã¥ÍºÖ§Q³¡¹«~ÃĪ«ºÞ²z¸pq©ó105¦~11¤ë3¤é(¥|)¤U¤È14:00-17:00¡A°²¹ÃĸpÃħ©¤j¼Ó2¼ÓB201·|ij«Ç¥l¶}¡u105¦~«×²Ä2¦¸ÂåÀø¾¹§÷ªk³W¤ÎºÞ²z·¾³q°Q½×·|ij¡v¡A¥»¤½·|¥Ñ¼ï¨q¶³±`°È²z¨Æ¡B³\¨qøÊ°Æ¥D©e¤Î±i¤¯»¨°Æ¥D©e¥Nªí¥X®u¡C ƒÜ ªñ ´Á °T ®§ 1. °]¹Îªk¤HÂåÃÄ«~¬dÅ礤¤ßq©ó105¦~11¤ë16¤é(¤T)¤U¤È15:00-16:30¡A°²ÂåÃÄ«~¬dÅ礤¤ßC201·|ij«Ç¥l¶}¡i105¦~²Ä6¦¸²£©x¾Ç·|ij¡j¡A¥»¤½·|¥Ñ¾Gµq¤¤¥D¥ô©eû¤Î³\¯¾¾ì°Æ¥D¥ô©eû¥Nªí¥X®u¡C Âå Àø ¬F µ¦ »P ÃÄ »ù ¬Û Ãö °T ®§ ƒÜ ¥» ¶g °T ®§ 1. CAPA¡®TPADAÂåÀø¬Fµ¦»PÃÄ»ù©eû·|Áp®u·|ij©ó105¦~11¤ë01¤é(¤G)¤¤¤È12:00-14:00¡A°²¨â·|¦X¸p¿ì¤½·|ij«Ç(¥x¥_¥««Ø°ê¥_¸ô¤G¬q123¸¹3¼Ó)¥l¶}¡C ƒÜ ªñ ´Á °T ®§ 1. ½Ã¥ÍºÖ§Q³¡¤¤¥¡°·±d«OÀI¸p±N©ó105¦~12¤ë2¤é(¤)¤W¤È09:00-12:00¡A°²°·«O¸p18¼Ó§°ó¥l¶}¡u·sÃÄ«Øij¦¬¸ü§@·~¨t²Î»¡©ú·|¡v¡AÅwªï·|û¿ãÅD³ø¦W°Ñ¥[¡C Âå Àø °| ©Ò µo ®i ¬Û Ãö °T ®§ ƒÜ ªñ ´Á °T ®§ 1. CAPA¡®TPADA ÂåÀø°|©Òµo®i©eû·|Áp®u·|ij©ó105¦~11¤ë9¤é(¤T)¤¤¤È12:00-14:00¡A°²¨â·|¦X¸p¿ì¤½·|ij«Ç(¥x¥_¥««Ø°ê¥_¸ô¤G¬q123¸¹3¼Ó)¥l¶}¡C ·| °È µo ®i ¬Û Ãö °T ®§ ƒÜ ¥» ¶g °T ®§ 1. ¤¤µØ¥Á°ê¥þ°ê°Ó·~Á`·|q©ó105¦~11¤ë1¤é(¤G)¤U¤È13:30¡A°²¥x¥_ºÖµØ¤j¶º©±¦a¤U¤G¼ÓºÖµØÆU¥l¶}¡u²Ä70©¡°Ó¤H¸`¤j·|º[ª÷°Ó¼ú¹{¼ú¨å§¡v¡A¥»¤½·|¯Î·½¤ô²z¨Æªø¨üÁÜ¥X®u¡C ƒÜ ªñ ´Á °T ®§ 1. ¥»¤½·|q©ó105¦~12¦~6¤ë(¤G)¤U¤È13¡G00-17¡G00°²±iºaµo°òª÷·|°ê»Ú·|ij¤¤¤ß801·|ij«Ç(¥x¥_¥«¤¤¥¿°Ï¤¤¤s«n¸ô11¸¹)¡AÁ|¦æ¡u²Ä¤»©¡²Ä¤T¦¸·|û¥Nªí¤j·|¡v¡AÅwªï·|û¥Nªí¿ãÅD°Ñ¥[¡C °T ®§ Âà ª¾ ¡¯¤½·|¦¬¤å ½Ã¥ÍºÖ§Q³¡ µo¤å¤é´Á/¤å¸¹¡G105.11.01/³¡±Â¹¦r²Ä1051303290¸¹¨ç ¤½·|¦¬¤å105838¸¹(11¤ë) ¥D¦®¡G×¥¿¡u¿é¤J³W©w¡y508¡z³f«~¤ÀÃþ¸¹¦Cªí¡A¦pÄݹ«~©Î¹«~²K¥[ª«(§t»®Æ)¥Î³~ªÌ¡AÀ³¨Ì·Ó¡y¹«~¤Î¬ÛÃö²£«~¿é¤J¬dÅç¿ìªk¡z³W©w¡A¦V½Ã¥ÍºÖ§Q³¡¹«~ÃĪ«ºÞ²z¸p¿ì²z¹«~¿é¤J¬dÅç¡v¡A·~¸g¥»³¡©ó¤¤µØ¥Á°ê105¦~11¤ë1¤é¥H³¡±Â¹¦r²Ä1051303285¸¹¤½§i×¥¿µo¥¬¡A¨Ã¦Û¤¤µØ¥Á°ê105¦~11¤ë1¤é¥Í®Ä¡A©ó¥»³¡¹«~ÃĪ«ºÞ²z¸p©xºô(http://www.fda.gov.tw/TC/index.aspx)¤½¥¬¡A½Ð¬d·Ó¨ÃÂા©ÒÄÝ¡C¡°¤½¨ç¤U¸ü¡Bªþ¥ó µo¤å¤é´Á/¤å¸¹¡G105.11.1/³¡±Â¹¦r²Ä1051302820A¸¹¨ç ¤½·|¦¬¤å105839¸¹(11¤ë) ¥D¦®¡G¡u¿é¤J³W©w¡y508¡z³f«~¤ÀÃþ¸¹¦Cªí¡A¦pÄݹ«~©Î¹«~²K¥[ª«(§t»®Æ)¥Î³~ªÌ¡AÀ³¨Ì·Ó¡y¹«~¤Î¬ÛÃö²£«~¿é¤J¬dÅç¿ìªk¡z³W©w¡A¦V½Ã¥ÍºÖ§Q³¡¹«~ÃĪ«ºÞ²z¸p¥Ó½Ð¿ì²z¹«~¿é¤J¬dÅç¡v¡A·~¸g¥»³¡105¦~11¤ë1¥H³¡±Â¹¦r²Ä1051302818¸¹¤½§i¹w§i¡A½Ð¬d·Ó¨ÃÂા©ÒÄÝ¡C¡°¤½¨ç¤U¸ü¡Bªþ¥ó µo¤å¤é´Á/¤å¸¹¡G105.11.3/³¡±Â°ê¦r²Ä10504018483¸¹¨ç ¤½·|¦¬¤å105846¸¹(11¤ë) ¥D¦®¡G·s¼W¡uÃh¯S-ÂĹy¯gÔ¸s¡v¨u¨£¯e¯f¤Î×¥¿¡uMNGIE¯gÔ¸s²É½uÅé©Ê¯«¸gG¸z¸£¯fÅܯgÔ¸s¡v¨u¨£¯e¯f¤§ICD-10-CM¶EÂ_¥N½X¡A·~¸g¥»³¡©ó¤¤µØ¥Á°ê105¦~11¤ë3¤é¥H³¡±Â°ê¦r²Ä1050401848¸¹¤½§i¡A¯÷ÀË°e¤½§i¼v¥»¡]§tªþ¥ó¡^1¥÷¡A½Ð¬d·Ó¡C¡°¤½¨ç¤U¸ü µo¤å¤é´Á/¤å¸¹¡G105.11.03/³¡±Â¹¦r²Ä1051411569¸¹¨ç ¤½·|¦¬¤å105850¸¹(11¤ë) ¥D¦®¡GÀË°e¥»³¡¡u§tÂùÁC»ÄÆQÃþ¦¨¤ÀÃÄ«~¤§ÃÄ«~·ÀIºÞ²zpµe®Ñ¡v¤½§i¼v¥»¤A¥÷¡A´f½ÐÂા©ÒÄÝ·|û¡A½Ð¬d·Ó¡C¡°¤½¨ç¤U¸ü¡Bªþ¥ó ½Ã¥ÍºÖ§Q³¡¹«~ÃĪ«ºÞ²z¸p µo¤å¤é´Á/¤å¸¹¡G105.10.28/ FDAÃĦr²Ä1051411322¸¹¨ç ¤½·|¦¬¤å105831¸¹(10¤ë)
¥D¦®¡G¦³Ãö®Öã¿é¤J¤§¦Û¥Îì®ÆÃijø¼o¤Î¤w®Ö㤧¦Û¥Îì®ÆÃÄ¡BÃĪ«¼Ë«~¤Î¸Õ»sì®ÆÃijf«~¶i¤f¦P·N®Ñú¾P¬ÛÃö¨Æ©y¡A¸Ô¦p»¡©ú¬q¡A½ÐÂા©ÒÄÝ·|û¶gª¾¡A½Ð¬d·Ó¡C¡° ¤½¨ç¤U¸üµo¤å¤é´Á/¤å¸¹¡G105.10.31/ FDA·¦r²Ä1051105583¸¹¨ç ¤½·|¦¬¤å105834¸¹(10¤ë) ¥D¦®¡G¦³Ãö¡u¦èÃÄÃÄ«~Àu¨}»s³y³W½d(²Ä¤T³¡¡G¹B¾P)¤§¬I¦æ®Éµ{»P°t®M±¹¬I¡v«áÄò°õ¦æ¤è®×¡A¸Ô¦p»¡©ú¬q¡A½ÐÂા©ÒÄÝ·|ûª¾·Ó¡C¡°¤½¨ç¤U¸ü µo¤å¤é´Á/¤å¸¹¡G105.11.02/ FDAÃĦr²Ä1051411633¸¹¨ç ¤½·|¦¬¤å105843¸¹(11¤ë) ¥D¦®¡GÀË°e§tfulvestrant¦¨¤ÀÃÄ«~¤§¡uÃÄ«~¦w¥þ¸ê°T·ÀI·¾³qªí¡v¡A½ÐÂા©ÒÄÝ·|û¡A½Ð¬d·Ó¡C¡°¤½¨ç¤U¸ü ½Ã¥ÍºÖ§Q³¡¤¤¥¡°·±d«OÀI¸p µo¤å¤é´Á/¤å¸¹¡G105.10.31/°·«O¼f¦r²Ä1050036657¸¹¨ç ¤½·|¦¬¤å105840¸¹(10¤ë) ¥D¦®¡G³qª¾¥»«OÀISyprine 250mg cap.ÃÄ«~105¦~12¤ë1¤é¤ä¥I»ù®æ²§°Ê±¡§Î¡A¸Ô¦p»¡©ú¡A½Ð¬d·Ó¨ÃÂા©ÒÄÝ·|û©Î¯S¬ùÂåÀø°|©Ò¡C¡°¤½¨ç¤U¸ü µo¤å¤é´Á/¤å¸¹¡G105.11.2/°·«O¼f¦r²Ä1050036661¸¹¨ç ¤½·|¦¬¤å105849¸¹(11¤ë) ¥D¦®¡GÀË°e105¦~10¤ë20¤é¥l¶}¤§¡u¥þ¥Á°·±d«OÀIÃĪ«µ¹¥I¶µ¥Ø¤Î¤ä¥I¼Ð·Ç¦@¦PÀÀq·|ijÃÄ«~³¡¤À²Ä22¦¸(105¦~10¤ë)·|ij¡v¬ö¿ý¤A¥÷¡A¦pªþ¥ó¡A½Ð¬d·Ó¡C¡°¤½¨ç¤U¸ü
»O¥_¥«¬F©²½Ã¥Í§½ µo¤å¤é´Á/¤å¸¹¡G105.11.1/¥_¥«½Ã¹ÃĦr²Ä10556626700¸¹¨ç¤½·|¦¬¤å105835¸¹(11¤ë) ¥D¦®¡G¦³Ãö¤H¥Í»sÃĪѥ÷¦³¤½¥q¤§²£«~¡u±¹F·s»Äµh³n»I¡©ªñ¦¿¥S§Ì¡ªMENTSHIN-Q OINTMENT ¡§OMI BROTHERHOOD¡¨ ¡]½Ã¸pÃÄ»s¦r²Ä043283¸¹¡^¡v¡]§å¸¹30336¡B30337¡B30338¡B30339¡B30340¡B30341¡B30342¡B30343¡B30344¡B30345¡B30346¡B30347¡B30348¡B30349¤Î30350¡B30351¡B30352¡B30353¡B30354¡B30355¡B30356¡B30357¡B30358¡B30359¡B30360¡B30361¡B30362¡B30363¡B30364¤Î30365¡F¦@30§å¡^¦^¦¬¤@®×¡A´f½Ð¨ó§U°t¦X¦U¶µ¦^¦¬§@·~¡A¸Ô¦p»¡©ú¬q¡A½Ð¬d·Ó¡C¡°¤½¨ç¤U¸ü µo¤å¤é´Á/¤å¸¹¡G105.11.2/¥_¥«½Ã¹ÃĦr²Ä10556716500¸¹¨ç¤½·|¦¬¤å105842¸¹(11¤ë) ¥D¦®¡G¦³Ãö¤H¥Í»sÃĪѥ÷¦³¤½¥q¤§²£«~¡u¡§¤H¥Í¡¨¥Ò°ò½¦Ån¡]¤º½ÃÃÄ»s¦r²Ä013007¸¹¡A§å¸¹8091¡^¡v©M¡u·ÀÅ~¹ç¡]¤º½Ã¦¨»s¦r²Ä000969¸¹¡A§å¸¹5174¡^¡v¤§ÃÄ«~¦^¦¬¤@®×¡A´f½Ð¨ó§U°t¦X¦U¶µ¦^¦¬§@·~¡A¸Ô¦p»¡©ú¬q¡A½Ð¬d·Ó¡C¡°¤½¨ç¤U¸ü µo¤å¤é´Á/¤å¸¹¡G105.11.3/¥_¥«½Ã¹ÃĦr²Ä10556704300¸¹¨ç¤½·|¦¬¤å105845¸¹(11¤ë) ¥D¦®¡G¦³Ãöº®¤H»sÃĪѥ÷¦³¤½¥q±µ¨üº¿¬ì¶©ªÑ¥÷¦³¤½¥q©e°U»s³y¤§²£«~¡uÅö¯÷·R³n½¦Ån300²@§J¡]½Ã¸pÃÄ»s¦r²Ä047646¸¹¡A§å¸¹A223¡BD013¡BH163¡BH173¡^¡v¤§ÃÄ«~¤@®×¡A´f½Ð¨ó§U°t¦X¦U¶µ¦^¦¬§@·~¡A¸Ô¦p»¡©ú¬q¡A½Ð¬d·Ó¡C¡°¤½¨ç¤U¸ü µo¤å¤é´Á/¤å¸¹¡G105.11.4/¥_¥«½Ã¹ÃĦr²Ä10556779600¸¹¨ç¤½·|¦¬¤å105851¸¹(11¤ë) ¥D¦®¡G¦³Ãö°·±d¤Ñ¨ÏªÑ¥÷¦³¤½¥q«ù¦³¤§¡u¡§°·±d¤Ñ¨Ï¡¨ Âå¥Î¤f¸n¡]¥¼·Àµß¡^¡v¡]½Ã¸pÂå¾¹»s³ü¦r²Ä003568¸¹¡^ÂåÀø¾¹§÷³\¥iÃÒ¸g½Ã¥ÍºÖ§Q³¡¤½§iµù¾P¡A´f½ÐÂા©ÒÄÝ·|û¡A°t¦X¦^¦¬§@·~¬ÛÃö¨Æ©y¡A½Ð¬d·Ó¡C¡°¤½¨ç¤U¸ü ¥xÆW¦~»´ÃÄ®v¨ó·| µo¤å¤é´Á/¤å¸¹¡G105.10.28/¦~»´ÃÄ(¸©)¦r²Ä105036¸¹¨ç ¤½·|¦¬¤å105836¸¹(10¤ë) ¥D¦®¡GÀË°e¥»·|105¦~10¤ë20¤é¥l¶}¤§²Ä¥|¦¸¡u«D³B¤èÃÄ«~¸ê°T©öŪ©Ê®y½Í·|¡v¬ö¿ý¤Î¨ä¬ÛÃöªþ¥ó¤@¥÷¡A¬ÛÃö¤º®e¤´¥H¹«~ÃĪ«ºÞ²z¸p¥¿¦¡µo§G¤§¤½§i¬°¥D¡A½Ð ¬d·Ó¡C¡° ¤½¨ç¤U¸ü
|