¦¬¤å¦r¸¹
|
¨Ó¤å¾÷Ãö
|
¨Ó¤å¤é´Á
|
¨Ó¤å¦r¸¹
|
¨Æ¥Ñ
|
1130510
|
»O¥_¥«¬F©²½Ã¥Í§½
|
113/07/01
|
¥_¥«½Ã¹ÃĦr²Ä1133130261¸¹
|
¦³Ãö½Ã¥ÍºÖ§Q³¡113¦~6¤ë25¤é½Ã±Â¹¦r²Ä1131403383¸¹¤½§iµù¾PÀs¤j¥Í§ÞªÑ¥÷¦³¤½¥q«ù¦³¤§¡uÆQ»Äf¥Ò³Â¶ÀÆP¡v¡]½Ã¸pÃÄ¿é¦r²Ä025940¸¹¡^¡B¡u¥ª¿ÕªN««¡v¡]½Ã¸pÃij°¿é¦r²Ä000314¸¹¡^¡B¡uÆQ»Ä¹p¥§´À©w¡v¡]½Ã³¡ÃÄ¿é¦r²Ä027216¸¹¡^¡B¡u©ö¹F¥¡v¡]½Ã³¡Ãij°¿é¦r²Ä000807¸¹¡^µ¥4¶µÃÄ«~³\¥iÃÒ¤@®×¡A½ÐÂા©ÒÄÝ·|û°t¦X¬ÛÃö¦^¦¬¨Æ©y¡A½Ð¬d·Ó¡C
|
1130512
|
½Ã¥ÍºÖ§Q³¡¹«~ÃĪ«ºÞ²z¸p
|
113/07/02
|
FDAÃĦr²Ä1131408236¸¹
|
¦]À³¬y¦æ©Ê¯e¯f¥ÎÃĻݨD¡A½ÐÂા©ÒÄÝ·|û¡A½T«OÃÄ«~éw¨ÑÀ³¡A¸Ô¦p»¡©ú¬q¡A½Ð¬d·Ó¡C
|
1130513
|
»O¥_¥«¬F©²½Ã¥Í§½
|
113/07/02
|
¥_¥«½Ã¹ÃĦr²Ä11331306782¸¹
|
¦³Ãö©¯¥Í¹ê·~ªÑ¥÷¦³¤½¥q¦^¦¬¡u¼ÚÄõÀR½¤¦ç¿õ5²@§J(½Ã³¡ÃÄ»s¦r²Ä058028¸¹)¡v¡]§å¸¹N1376¡^ÃÄ«~¤@®×¡A½Ð¨ó§UÂા©ÒÄÝ·|û¡A½Ð¬d·Ó¡C
|
1130514
|
»O¥_¥«¬F©²³Ò°Ê§½
|
113/07/03
|
¥_¥«³Ò°Ê¦r²Ä1136077662¸¹
|
¬°¼W¶i³Ò¸ê©M¿Ó¡A¨Ã«Å¾É³Ò¤u¨É¦³Â÷½uÅvÆ[©À¡A¥»§½«¥Ó¨Ã½Ð¶Q·|°Ñ·Ó¡u»O¥_¥«¨Æ·~³æ¦ì©~®a¤u§@³Ò°Ê±ø¥ó«O»Ù«ü¾Éì«h¡v¤Î¡u¦Û¥DÀˮֵû¤Àªí¡v¿ì²z¡A½Ð¬d·ÓÂા¡C
|
1130516
|
½Ã¥ÍºÖ§Q³¡¹«~ÃĪ«ºÞ²z¸p
|
113/07/04
|
FDAÃĦr²Ä1131408692¸¹
|
¥»¸pÀÀ©ó113¦~10¤ë¥l¶}»PÃÄ·~¤½¨ó·|·¾³q¨ó°Ó·|ij¡A½Ð©ó113¦~7¤ë26¤é«e´£¨Ñ°Q½×ijÃD¡AÀ˰e´£®×ªí¦pªþ¥ó¡A¹O´Á¤£¤©¨ü²z¡A½Ð¬d·Ó´f´_¡C
|
1130517
|
»O¥_¥«¬F©²½Ã¥Í§½
|
113/07/04
|
¥_¥«½Ã¹ÃĦr²Ä1133129301¸¹
|
°]¹Îªk¤HÃÄ®`±ÏÀÙ°òª÷·|¨ü¹«~ÃĪ«ºÞ²z¸p©e°U©ó113¦~8¤ë29¤é¿ì²z¡uÃÄ«~ÄY«¤£¨}¤ÏÀ³³q³øªk³W¡v»¡©ú·|¡A·q½Ð¨ó§UÂા©ÒÄÝ·|û¡A½Ð¬d·Ó¡C
|
1130518
|
½Ã¥ÍºÖ§Q³¡¹«~ÃĪ«ºÞ²z¸p
|
113/07/04
|
FDAÃĦr²Ä1131402947¸¹
|
¦³Ãö¹w§i¡uICHE10¡GÁ{§É¸ÕÅ礤¹ï·Ó²Õªº¿ï¾Ü»P¬ÛÃö¨Æ¶µ(CHOICEOFCONTROLGROUPANDRELATEDISSUESINCLINICALTRIALS)¡v(¯ó®×)¤@®×¡A½Ð¦Ü¥»¸pºô¯¸(http://www.fda.gov.tw/)¤§¡u¤½§i¸ê°T¡v¤U¸ü¡C´f½ÐÂા©ÒÄÝ·|û¤Î¬ÛÃö³æ¦ì¡A¹ï¤º®e¦p¦³·N¨£©Î¬ÛÃö«ØÄ³ªÌ¡A½Ð¦Ûµo¤å¤é°_60¤é¤º³¯z·N¨£©Î¬¢¸ß©Ó¿ìµ¡¤f¡C
|
1130519
|
»O¥_¥«¬F©²½Ã¥Í§½
|
113/07/04
|
¥_¥«½Ã¹ÃĦr²Ä1133131006¸¹
|
¦³Ãö½Ã¥ÍºÖ§Q³¡¤½§iµù¾P§ß°¥¶T©ö¦³¤½¥q«ù¦³¤§¡u¦Ê¸£±d½¤¦ç¿õ¡v¡]½Ã¸pÃÄ¿é¦r²Ä016451¸¹¡^µ¥2±iÃÄ«~³\¥iÃÒ¤@®×¡A½Ð¶Q·|Âા©ÒÄÝ·|û¡A½Ð¬d·Ó¡C
|
1130520
|
»O¥_¥«¬F©²½Ã¥Í§½
|
113/07/04
|
¥_¥«½Ã¹ÃĦr²Ä1133130238¸¹
|
¦æ¬F°|©ó113¦~6¤ë25¤é¤½§i×¥¿¡uºÞ¨îÃÄ«~¤À¯Å¤Î«~¶µ¡v³¡¤À¤À¯Å¤Î«~¶µ¡A¨Ã¦Û113¦~6¤ë25¤é¥Í®Ä¡A½ÐÂા©ÒÄÝ·|ûª¾±x¡A½Ð¬d·Ó¡C
|
1130523
|
½Ã¥ÍºÖ§Q³¡¹«~ÃĪ«ºÞ²z¸p
|
113/07/08
|
FDAÃĦr²Ä1130717138¸¹
|
¦³Ãö¶Q¤½¥q¥Ó½Ð½Õ¾ã¡u§Q±±¹[¤fªAÄa²G¥Î¯»¾¯5§J¡ALOKELMA5gPowderforOralSuspension¡]½Ã³¡ÃÄ¿é¦r²Ä028710¸¹¡^¡v¤Î¡u§Q±±¹[¤fªAÄa²G¥Î¯»¾¯10§J¡ALOKELMA10gPowderforOralSuspension¡]½Ã³¡ÃÄ¿é¦r²Ä028711¸¹¡^¡vÃÄ«~¦w¥þ©Ê©w´Á³ø§i¤§¸ê®Æ»`¶°ºI¤î¤é(DLP)¤@®×¡A´_¦p»¡©ú¬q¡A½Ð¬d·Ó¡C
|
1130524
|
»O¥_¥«¬F©²½Ã¥Í§½
|
113/07/08
|
¥_¥«½Ã¹ÃĦr²Ä1133131943¸¹
|
¬°«O»Ù¥Á²³¥ÎÃĦw¥þ¡A½Ð¨ó§UÂા©ÒÄÝ·|û½T¹ê¨Ì¾ÚÃĨƪkµ¥¬ÛÃö³W©w¿ì²z¡A½Ð¬d·Ó¡C
|
1130525
|
½Ã¥ÍºÖ§Q³¡¹«~ÃĪ«ºÞ²z¸p
|
113/07/09
|
FDAÃĦr²Ä1131408200¸¹
|
´f½Ð¶Q·|Âા©ÒÄÝ·|û¡A¦Û114¦~1¤ë1¤é°_¡A²ÓMªvÀø»s¾¯¤Î°ò¦]ªvÀø»s¾¯Á{§É¸ÕÅç®×¥ó¡A±N±Ä¥þ±½u¤W¥Ó¿ì¡A¸Ô¦p»¡©ú¬q¡A½Ð¬d·Ó¡C
|
1130527
|
»O¥_¥«¬F©²½Ã¥Í§½
|
113/07/10
|
¥_¥«½Ã¹ÃĦr²Ä1133131582¸¹
|
¦³Ãö½Ã¥ÍºÖ§Q³¡113¦~6¤ë28¤é½Ã±Â¹¦r²Ä1139047240¸¹¤½§iµù¾P½÷·ç¤jÃļtªÑ¥÷¦³¤½¥q«ù¦³¤§¡u®¦¤[¥½¤¦ç¿õ10²@§J¡v(½Ã¸pÃÄ¿é¦r²Ä022124¸¹)ÃÄ«~³\¥iÃÒ¤@®×¡A½ÐÂા©ÒÄÝ·|û°t¦X¬ÛÃö¦^¦¬¨Æ©y¡A½Ð¬d·Ó¡C
|
1130528
|
»O¥_¥«¬F©²½Ã¥Í§½
|
113/07/10
|
¥_¥«½Ã¹ÃĦr²Ä1133132190¸¹
|
¦³Ãö½Ã¥ÍºÖ§Q³¡113¦~7¤ë2¤é½Ã±Â¹¦r²Ä1131408246¸¹¤½§iµù¾PÀưӹê·~ªÑ¥÷¦³¤½¥q«ù¦³¤§¡u”¦h¼¯¥Í”¸ºñ¯À»É¶u¡v¡]½Ã¸pÃÄ¿é¦r²Ä024809¸¹¡^ÃÄ«~³\¥iÃÒ¤@®×¡A½ÐÂા©ÒÄÝ·|û°t¦X¬ÛÃö¦^¦¬¨Æ©y¡A½Ð¬d·Ó¡C
|
1130529
|
»O¥_¥«¬F©²½Ã¥Í§½
|
113/07/10
|
¥_¥«½Ã¹ÃĦr²Ä1133132352¸¹
|
¦³Ãö½Ã¥ÍºÖ§Q³¡113¦~7¤ë8¤é½Ã³¡¤¤¦r²Ä1130022492¸¹¤½§iµù¾P¶¶¤Ñ°óÃļtªÑ¥÷¦³¤½¥q«ù¦³¤§¡u“¶¶¤Ñ°ó”¥Õ«ó¨§¿@ÁYÁû²É¡v¡]½Ã¸pÃÄ»s¦r²Ä002066¸¹¡^µ¥7¥óÃÄ«~³\¥iÃÒ¤@®×¡A½ÐÂા©ÒÄÝ·|û°t¦X¬ÛÃö¦^¦¬¨Æ©y¡A½Ð¬d·Ó¡C
|
1130534
|
½Ã¥ÍºÖ§Q³¡
|
113/07/11
|
½Ã±Â¹¦r²Ä1131901183¸¹
|
¡u¹«~ÃĪ«¤ÆùÛ«~ÀËÅç«Ê½p¤Î¹ï·Ó¼Ð·Ç«~¨ÑÀ³¦¬¶O¼Ð·Ç¡v¡A·~¸g¥»³¡©ó¤¤µØ¥Á°ê113¦~7¤ë11¤é¥H½Ã±Â¹¦r²Ä1131901181¸¹¥O×¥¿µo¥¬¡A½Ð¬d·Ó(¨ÃÂા©ÒÄÝ)¡C
|
1130535
|
»O¥_¥«¬F©²½Ã¥Í§½
|
113/07/12
|
¥_¥«½Ã¹ÃĦr²Ä1133132221¸¹
|
¦³Ãö½Ã¥ÍºÖ§Q³¡113¦~7¤ë3¤é½Ã±Â¹¦r²Ä1131405300¸¹¤½§iµù¾P¦]µØ¥Í§Þ»sÃĪѥ÷¦³¤½¥q«ù¦³¤§¡u¦]¸¿Õ¿õ10²@§J¡v¡]½Ã³¡ÃÄ»s¦r²Ä058625¸¹¡^ÃÄ«~³\¥iÃÒ¤@®×¡A½ÐÂા©ÒÄÝ·|û°t¦X¬ÛÃö¦^¦¬¨Æ©y¡A½Ð¬d·Ó¡C
|
1130537
|
»O¥_¥«¬F©²½Ã¥Í§½
|
113/07/12
|
¥_¥«½Ã¹ÃĦr²Ä1133132684¸¹
|
¦³Ãö½Ã¥ÍºÖ§Q³¡113¦~7¤ë4¤é½Ã±Â¹¦r²Ä1131405301¸¹¤½§iµù¾P¿³«n¹ê·~ªÑ¥÷¦³¤½¥q«ù¦³¤§¡u°·¶Ê¶u½¤¦ç¿õ2.5²@§J¡v¡]½Ã¸pÃÄ»s¦r²Ä049071¸¹¡^¡B¡u°·¶Ê§Q¿õ2.5²@§J¡v¡]½Ã¸pÃÄ»s¦r²Ä048966¸¹¡^¡B¡u¿±d¿õ10²@§J¡]¨©¥iªâ¡^¡v¡]½Ã¸pÃÄ»s¦r²Ä035273¸¹¡^¦@3µ§ÃÄ«~³\¥iÃÒ¤@®×¡A½ÐÂા©ÒÄÝ·|û°t¦X¬ÛÃö¦^¦¬¨Æ©y¡A½Ð¬d·Ó¡C
|
1130539
|
½Ã¥ÍºÖ§Q³¡¹«~ÃĪ«ºÞ²z¸p
|
113/07/15
|
FDAÃĦr²Ä1130717647¸¹
|
¦³Ãö¶Q¤½¥q¥Ó½Ð½Õ¾ã¡uÀù¦Û¿m¥Ö¤Uª`®g¾¯¡ATecentriqSolutionforSubcutaneousInjection¡]½Ã³¡µß¬Ì¿é¦r²Ä001258¸¹¡^¡vÃÄ«~¦w¥þ©Ê©w´Á³ø§i¤§¸ê®Æ»`¶°ºI¤î¤é(DLP)¤@®×¡A´_¦p»¡©ú¬q¡A½Ð¬d·Ó¡C
|