À̹ø °è¾àÀº Áö³ 5¿ù ¾à 1600¾ï¿ø ±Ô¸ðÀÇ °ø±Þ °è¾à¿¡ À̾î 2ºÐ±â ÁøÇàµÈ µÎ ¹ø° ´ë±Ô¸ð °ø±Þ°è¾àÀÌ´Ù. ¹Ì±¹°ú À¯·´ µî¿¡¼ Áö¼ÓÀûÀ¸·Î ´Ã¾î³ª´Â Ç×ü ¹ÙÀÌ¿À½Ã¹Ð·¯ ¼ö¿ä¿Í ÃÖ±Ù À¯·´ÀǾàǰû(EMA, European Medicines Agency) »êÇÏ ¾à¹°»ç¿ëÀÚ¹®À§¿øȸ(CHMP, Committee for Medicinal Products for Human Use)·ÎºÎÅÍ ÆǸŠ½ÂÀÎ ±Ç°í¸¦ ¹ÞÀº ¾Æ¹Ù½ºÆ¾ ¹ÙÀÌ¿À½Ã¹Ð·¯ º£±×Á©¸¶ÀÇ ½Å¼ÓÇÑ ±Û·Î¹ú °ø±Þ¿¡ ´ëóÇϱâ À§ÇØ Ã¼°áµÆ´Ù.
½ÃÀå Á¶»ç±â°ü ½ÉÆ÷´ÏÇコ µ¥ÀÌÅÍ¿¡ µû¸£¸é ·¥½Ã¸¶´Â ¼¼°è ÃÖ´ë ¹ÙÀÌ¿ÀÀǾàÇ° ½ÃÀåÀÎ ¹Ì±¹¿¡¼ Áö³ 4¿ù ±âÁØ Á¡À¯À² 29.4%¸¦ ±â·ÏÇß´Ù. ÀÌ´Â Àü³âµµ 4¿ù ´ëºñ 1³â ¸¸¿¡ ¾à 13.7%Æ÷ÀÎÆ®(p) Áõ°¡ÇÑ ¼öÄ¡·Î ºü¸¥ Á¡À¯À² ¼ºÀåÀ» º¸ÀÌ°í ÀÖ´Ù.
·¥½Ã¸¶ÀÇ ÇÇÇÏÁÖ»ç Á¦ÇüÀÎ ·¥½Ã¸¶SC°¡ ÇöÀç ¹Ì±¹ ½ÃÀå »ó¾÷ȸ¦ ¸ñÇ¥·Î ÀÓ»ó 3»óÀ» ÁøÇà ÁßÀÎ ¸¸Å ·¥½Ã¸¶ÀÇ ²ÙÁØÇÑ Á¡À¯À² »ó½ÂÀº ÇâÈÄ ·¥½Ã¸¶SCÀÇ ¹Ì±¹ ½ÃÀå ÁøÃâ¿¡µµ ±àÁ¤ÀûÀ¸·Î ÀÛ¿ëÇÒ °ÍÀ¸·Î ±â´ëµÈ´Ù.
¼¿Æ®¸®¿ÂÀº À¯·´ ³» Çã°¡°¡ ÀÓ¹ÚÇÑ º£±×Á©¸¶ÀÇ ±Û·Î¹ú ½ÃÀå ÁøÃâµµ ¼µÎ¸£°í ÀÖ´Ù. ¾Æ¹Ù½ºÆ¾ ¹ÙÀÌ¿À½Ã¹Ð·¯ º£±×Á©¸¶´Â Áö³ 24ÀÏ(ÇöÁö ½Ã°¢) À¯·´ CHMP·ÎºÎÅÍ ÆǸŠ½ÂÀÎ ±Ç°í¸¦ ȹµæÇØ À¯·´¿¬ÇÕ ÁýÇàÀ§¿øȸ(EC, European Commission)ÀÇ ÃÖÁ¾ ÆǸŠÇã°¡¸¦ ±â´Ù¸®°í ÀÖ´Ù.
¶Ç ¹Ì±¹ ½ÄÇ°ÀǾ౹(FDA, U.S. Food and Drug Administration)¿¡µµ ÆǸŠÇã°¡¸¦ ½ÅûÇÑ »óÅ·Π¿¬³» ½ÂÀÎÀ» ±â´ëÇÏ°í ÀÖ´Ù.
¼¿Æ®¸®¿ÂÀº ÀÌ¹Ì º£±×Á©¸¶ÀÇ ¿À¸®Áö³Î ÀǾàÇ° °³¹ß»ç¿Í ±Û·Î¹ú ƯÇã ÇÕÀǵµ ¿Ï·áÇÑ »óÅ·ΠÀ¯·´°ú ¹Ì±¹ ³» Çã°¡°¡ ¿Ï·áµÇ¸é ºü¸£°Ô Á¦Ç°À» Ãâ½ÃÇÑ´Ù´Â °èȹÀÌ´Ù.
¼¿Æ®¸®¿Â °ü°èÀÚ´Â "±âÁ¸ ¹ÙÀÌ¿À½Ã¹Ð·¯ Ç°¸ñÀÇ °ø±Þ È®´ë¿Í ÇÔ²² ±Û·Î¹ú ½ÃÀå Ãâ½Ã¸¦ ¸ñÀü¿¡ µÐ Ç°¸ñÀÌ Ãß°¡µÇ¸é¼ ¾ÈÁ¤Àû ¼ºÀåÀ» À̾ ¼ö ÀÖ°Ô µÆ´Ù"¸ç "ÇϹݱ⿡µµ Á¦Ç°º° Çã°¡¿Í Ãâ½Ã Áö¿ª È®´ë°¡ ¿¹»óµÇ´Â ¸¸Å ¼ºÀå¿¡ ¼Óµµ¸¦ ³¾ ¼ö ÀÖµµ·Ï ÃÖ¼±À» ´ÙÇÏ°Ú´Ù"°í ¸»Çß´Ù.