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¹ï©óEMA ¦¬¥ó¤wµL·P¡A©Ò¦³ªº¨½µ{¸O¤w¸g³Q¦U¦ì¤¤¸Î¥ý¶iÌReview¨ì³£I¤U¨Ó¡AÀR¤ßµ¥¨CӤ몺À禬³øªí¡A¤~¬O³Ì¹ê¦bªº¡I |
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·|û¡G¹A¤Ò10147224 µoªí®É¶¡:2018/9/15 ¤W¤È 11:47:31²Ä 3557 ½g¦^À³
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tw.money.yahoo.com/%E5%85%AC%E5%91%8A-%E6%AD%90%E7%9B%9F%E8%97%A5%E5%93%81%E7%AE%A1%E7%90%86%E5%B1%80-ema-%E9%96%8B%E5%A7%8B%E5%AF%A9%E6%9F%A5%E4%B8%AD%E8%A3%95%E6%96%B0%E8%97%A5%E6%84%9B%E6%BB%8B%E7%97%85%E6%96%B0%E8%97%A5trogarzo%E4%B8%8A%E5%B8%82%E7%94%B3%E8%AB%8B-011643425.html |
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·|û¡G±¶10141423 µoªí®É¶¡:2018/9/15 ¤W¤È 10:57:35²Ä 3556 ½g¦^À³
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¥ÍÂåªÑ¡n¤¤¸Î·sÃÄ¡G·R´þ¯f·sÃÄTrogarzo¤W¥«¥Ó½Ð¡A¼Ú·ù¶}©l¼f¬d 2018/09/15 10:25:38 ¬ÛÃö¡G¤¤¸Î ¡i®É³ø-¥x¥_¹q¡j¤¤¸Î·sÃÄ¡]4147¡^¤½§i¡A¥Î©óªvÀø·R´þ¯f·sÃÄTrogarzo¦b¼Ú¬w¥Ó½ÐÃÄÃÒ©M¦æ¾Pªº¹Ù¦ñTheratechnologies©ó9¤ë14¤é¥¿¦¡«Å¥¬¡A¼Ú·ùÃÄ«~ºÞ²z§½¡]EMA¡^½T»{¤¤¸Îªº·R´þ¯f·sÃÄTrogarzo¤W¥«¥Ó½Ð¤å¥ó»ô¥þ¡A¤w¶}©l¶i¦æ¼f¬d¡C¼f¬d¶}©l®É¶¡¬°9¤ë13¸¹¡A¨Ì·Ó§Ö³t¼f®Ö¸ê®æ¡AEMAÀ³¦b150¤Ñ¤º¼f¬d§¹²¦¡C ¡@Trogarzo¤w©ó¤µ¦~3¤ë6¸¹Àò±o¬ü°êFDAªº¤W¥«³\¥i¡C¦¹¦¸¦VEMA°e¥ó¬O¨Ï¥ÎFDA¤w®Ö¥iªº¬Û¦P¼Æ¾Ú¡C ¤¤¸Î·sÃĪí¥Ü¡AY¤@¤Á¶¶§Q¡A¨Ì·Ó§Ö³t¼f¬d®Éµ{¡B¦Ò¶q¦^µª°ÝÃD¤Îq»ùªº°Q½×¡A¦X²z±À´úTrogarzo¦b¼Ú¬w¤W¥«®É¶¡ÂI¬ù¦b108¦~©³¡A±©ÃÄÃÒ¹ê»Ú®Öã®É¶¡¤Îã»é»P§_¬°¥DºÞ¾÷Ãö¾Åv¡C |
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European Medicines Agency Validates Marketing Authorization Application for Trogarzo™ GlobeNewswire¡ESeptember 14, 2018 MONTREAL, Sept. 14, 2018 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (Theratechnologies) (TH.TO) is pleased to announce that the European Medicines Agency (¡§EMA¡¨) has confirmed the validity of the marketing authorization application for Trogarzo™ (ibalizumab) filed on August 28, 2018. The validation confirms the submission is complete, and begins the EMA¡¦s centralized review process. As a result, the start of procedure date has been set to September 13, 2018. The EMA will review the application for Trogarzo™ under the accelerated assessment procedure. The accelerated assessment procedure, which was granted in an earlier decision from the EMA, reduces the timeframe for a recommendation by the EMA to 150 review days from 210 review days for the normal procedure. Theratechnologies seeks to obtain approval for Trogarzo™ for the treatment of multidrug resistant Human Immunodeficiency Virus-1 (MDR HIV-1) in the European Union. The application is based on the same clinical trial data that was reviewed by the FDA to grant marketing authorization of Trogarzo™ in the United States. ¡§We are very pleased with the way the European file is progressing. We believe that Europe could also represent a substantial market for the drug if approved by the EMA. The market uptake in Europe could benefit from the positive reaction and prior experience with Trogarzo™ in the United States,¡¨ said Luc Tanguay, President and Chief Executive Officer, Theratechnologies Inc. |
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