service_tel
service_tel
0800-268-882
0800-268-883
±¾³æ µn¤J/µù¥U
®õ¦X¥Í§ÞÃÄ«~
¥Í§Þ¡ÐÂåÀøÃþ
¿³Âd
¤½§i¥»¤½¥qTAH9901¤p¨à¹L°Ê¯g¶K¤ù (Methylphenidate Transdermal
2017/11/29

¤½§i¥»¤½¥qTAH9901¤p¨à¹L°Ê¯g¶K¤ù (Methylphenidate Transdermal Patch)²£«~±M§Q¤w³q¹L¼f¬dÀò±o¬ü°ê±M§Q³\¥i¡C

1.¨Æ¹êµo¥Í¤é:106/11/28
2.¤½¥q¦WºÙ:®õ¦X¥Í§ÞÃÄ«~ªÑ¥÷¦³­­¤½¥q
3.»P¤½¥qÃö«Y(½Ð¿é¤J¥»¤½¥q©ÎÁpÄݤ½¥q):¥»¤½¥q
4.¬Û¤¬«ùªÑ¤ñ¨Ò(­Y«e¶µ¬°¥»¤½¥q¡A½Ð¶ñ¤£¾A¥Î):¤£¾A¥Î
5.µo¥Í½t¥Ñ:
¥»¤½¥q©Ò¬ãµo¤§TAH9901¤p¨à¹L°Ê¯g¶K¤ù(Methylphenidate Transdermal Patch)²£«~
±M§Q¡A±M§Q¦WºÙ¡uTransdermal Delivery System Containing Methylphenidate Or
Its Salts and Methods Thereof¡v¡A¤w³q¹L¬ü°ê±M§Q¤Î°Ó¼Ð§½¼f¬dÀò±o¬ü°ê±M§Q³\¥i
6.¦]À³±¹¬I:µL
7.¨ä¥LÀ³±Ô©ú¨Æ¶µ:
¤@¡B¬ãµo·sÃĦWºÙ©Î¥N¸¹¡GTAH9901¤p¨à¹L°Ê¯g¶K¤ù¡C
¤G¡B¥Î³~¡GƒÜTAH9901¬°¤p¨à¹L°Ê¯g¶K¤ù¡A¬°Á×§K¿õ¾¯¤£©ö§]ªA¡A§ï¦¨¶K¤ù¤è«K¨àµ£¨Ï
¥Î¡A¼W¥[¨àµ£±wªÌ¾A¥Î©Ê¡C
¤T¡B¹w­p¶i¦æ¤§©Ò¦³¬ãµo¶¥¬q¡G¤w§¹¦¨³æ¦¸»¼¼W¾¯¶q«e´ÁÁ{§É¸ÕÅç(SAD Study, Single
Ascending Dose Study)¡C
¥|¡B¥Ø«e¶i¦æ¤¤¤§¬ãµo¶¥¬q¡G
1.´£¥X¥Ó½Ð/³q¹L®Ö­ã/¤£³q¹L®Ö­ã¡G¤£¾A¥Î¡C
2.¥¼³q¹L¥Øªº¨Æ·~¥DºÞ¾÷Ãö³\¥iªÌ¡A¤½¥q©Ò­±Á{¤§­·ÀI¤Î¦]À³±¹¬I¡G¤£¾A¥Î¡C
3.¤w³q¹L¥Øªº¨Æ·~¥DºÞ¾÷Ãö³\¥iªÌ¡A¥¼¨Ó¸gÀç¤è¦V¡G¤£¾A¥Î¡C
4.¤w§ë¤J¤§¬ãµo¶O¥Î¡G¦]¯A¤Î¥¼¨Ó°ê»Ú±ÂÅv½Í§P¸ê°T¡A¬°Á×§K¼vÅT±ÂÅvª÷ÃB¡A¥H«O»Ù§ë
¸ê¤HÅv¯q¡A¼È¤£´¦ÅS¡C
¤­¡B±N¦A¶i¦æ¤§¤U¤@¶¥¬q¬ãµo¡G±N´M¨D¦X§@¹Ù¦ñ¥H¶i¦æ¤U¤@¶¥¬qÃöÁä©Ê¥Íª«¬Ûµ¥©Ê¸ÕÅç
(pivotal bioequivalence study)¡C
1.¹w­p§¹¦¨®É¶¡¡G¤£¾A¥Î¡C
2.¹w­pÀ³­t¾á¤§¸q°È¡G¤£¾A¥Î¡C
¤»¡B¥«³õ²{ªp:¨Ì¾Ú¥Á°ê105¦~IMS Data¡A¸ÓÃþ«¬ªvÀø¤p¨à¹L°Ê¯gÃĪ«¦b¬ü°ê¦a°Ï¥«³õÁ`
³W¼Ò¬ù·s¥x¹ô560»õ¤¸¡C®õ¦X¬ãµo¤§Methylphenidate¤p¨à¹L°Ê¯g¶K¤ùÃÄ«~¯à³Ð³yªºÀ禬
¡A±N¨Ì¥¼¨Ó¹ê»Ú±ÂÅv©Î¾P°â±¡§Î¦Ó©w¡C
¤C¡B§ë¸êĵ»y:·sÃĶ}µo®Éµ{ªø¡B§ë¤J¸g¶O°ª¥B¥¼«OÃÒ¤@©w¯à¦¨¥\¡A¦¹µ¥¥i¯à¨Ï§ë¸ê­±
Á{­·ÀI¡A§ë¸ê¤HÀ³¼f·V§PÂ_ÂÔ·V§ë¸ê¡C
<ºK¿ý¤½¶}¸ê°TÆ[´ú¯¸>
¿³Âd¥¿±`¥æ©ö¤¤
ªÑªF·|°T®§
³Ìªñ¤@´ÁªÑªF±`·|¤w©ó 114/06/05 µ²§ô
ªÑªFÅv®§³qª¾
114¦~¿ì²z²{¼W¡A¨C±i¥i»{12.250108 ªÑªÑ¡A»{ÁÊ»ù 150 ¤¸¤¸
103¦~¿ì²z´«²¼¡A´«ªÑ¤ñ²v: 0.00
¥»ºô¯¸¸ê°T¨Ó·½¬°Âd¶R¤¤¤ß¡B¤½¶}¸ê°TÆ[´ú¯¸¡B¸gÀÙ³¡°Ó·~¥q¡C§ó·s³t«×¦³¨Ç³\®t²§¡A­Y¦³¤£²Å¤§³B½Ð¨Ì¸Óºô¯¸¸ê°T¬°¥D¡C¥»¯¸¸ê®Æ¶È¨Ñ°Ñ¦Ò¡A½Ð¥¼¤W¥«§ë¸ê¤H¦Û¦æ·r°u¡A¨Ì¥»¸ê®Æ¥æ©ö«á¬ÕÁ«½Ð¦Û­t¡C
¥»¯¸´£¨Ñ¥¼¤W¥«ªÑ²¼ªº°ò¥»¸ê®Æ|ªÑ»ù|¥¼¤W¥«ªÑ²¼¶R½æ¿Ô¸ß|°]°È³øªí|¤ëÀ禬|¨«¶Õ¹Ï|·s»D¤½§i¡AÅwªï©Ò¦³¹ï¥¼¤W¥«¤½¥q¦³¿³½ìªº§ë¸ê¤H°Ñ¦Ò¡C
ªA°È¹q¸Ü: 0800-268-882¡B 0800-268-883
copyright(c) by ¥¼¤W¥«|¥¼¤W¥«ªÑ²¼-§ë¸ê¹F¤H±M·~ºô All Right Reserved.