H24004 ⫵⅖㉳ᅉ⳦䜢༶ྠᐃ䛩䜛䜸䞁䞉䝃䜲䝖᳨ᰝ䝅䝇䝔䝮䛾㛤Ⓨ Class ? ◊་ჾ䠄ᰴ䠅䚸䠄ᰴ䠅䝯䝍䝪䝇䜽䝸䞊䞁䚸ᮾி་⛉ ⫵⅖㉳ᅉ⳦䛾⣲᪩䛔䚸⡆౽䛺ྠᐃ䜈䛾せᮃ ౨௹ z ⫵⅖䛿ឤᰁṚ⪅ᩘ1䚸ᝈ⪅䛾95䠂䛜ධ㝔䠄ᖹᆒ15 ᪥䠅䚸ᖺ㛫་⒪㈝1600൨௨ୖ䚹 z ⫵⅖䜢ᘬ䛝㉳䛣䛩⳦䛾✀㢮䛿ከ䛟䚸䛭䜜䛮䜜␗䛺䜛ฎ⨨ 䛜ᚲせ䛷䛒䜛䛜ᝈ⪅䛾35䠂䛻ᑐ䛧䛶㉳ᅉ⳦䛜᫂䛾䜎䜎 ⒪䛜㛤ጞ䛥䜜䛶䛚䜚䚸㐺ษ䛺ฎ⨨䛾㐜䜜䛷㔜䜢ᣍ 䛝䛛䛽䛺䛔䛯䜑䚸㎿㏿䛺㉳ᅉ⳦䛾ྠᐃ䛜ồ䜑䜙䜜䛶䛔䜛䚹 ᚑ᮶2䡚3᪥䜢せ䛧䛯⫵⅖㉳ᅉ⳦ྠᐃ䜢䛭䛾ሙ䛷ᐇ z ᮏ䝅䝇䝔䝮䛷䛿䚸እ᮶ᝈ⪅䛾⫵⅖㉳ᅉ⳦䜢15ศ䛷ྠᐃ䚹 䜎䛯䚸ᚑ᮶䛾ᇵ㣴ἲ䜘䜚㧗⢭ᗘ䛺㑇ఏᏊ䝺䝧䝹䛾ྠᐃἲ 䜢⏝䚹 z ከᛁ䛺་⒪⌧ሙ䛻ྜ䛳䛯༢⣧᧯స䛾᳨ᰝ䜢ᐇ⌧䚹 z 㐺ษ䛷㎿㏿䛺ฎ⨨䛜ቑຍ䛧䚸QOL䛾ྥୖ䚸ධ㝔ᝈ⪅䚸ධ 㝔᪥ᩘ䛾ῶᑡ䠄་⒪⤒῭ⓗຠᯝ100൨௨ୖ䠅䛜ぢ㎸䜎 䜜䜛䚹 ౨˳ửේẲề رẾề μềử15Ў Ểኳʕ ἍἕἚẴỦ ౨Јݣᝋᓏᆔ ◊་ჾ䠄ᰴ䠅䠖⊂ᛶ䛻䛣䛰䜟䛳䛯〇ရ䜢ᒎ㛤 ◊✲㛤Ⓨᆺ་⒪ᶵჾ䝯䞊䜹䞊䛸䛧䛶䚸䛻㯞㓉㛵㐃䚸㝔ឤᰁ㜵Ṇ㛵 㐃〇ရ䛾◊✲䚸〇㐀㈍䜢⾜䛳䛶䛔䜛䚹ᮏ䝅䝇䝔䝮䛷䛿᳨ᰝ⨨ᮏయ 䛸᳨ᰝ䜻䝑䝖䠄ᾘ⪖ရ䠅䛾㈍䛻䜘䜚䚸ᅜෆୖ100൨௨ୖ䜢≺䛖䚹 䛾ឤᰁ䜈䛾ᒎ㛤䚸ᾏእᒎ㛤䜒≺䛖䚹 ⫵⅖⌫⳦䚸䠩䠮䠯䠝䚸㯤Ⰽ䝤䝗䜴⌫⳦䚸䝬䜲䝁 䝥䝷䝈䝬䚸⤖᰾⳦䚸䝺䝆䜸䝛䝷䚸ⓒ᪥တ䚸䜲䞁 䝣䝹䜶䞁䝄⳦䚸⫵⅖ᱰ⳦䚸⥳⮋⳦䚸䝰䝷䜽䝉 䝷 䝁䞁䝋䞊䝅䜰䝮 PMDA ➨୕⪅ㄆドᶵ㛵 ◊✲ᶵ㛵 ┦ㄯ䞉⏦ㄳ ᮾி་⛉Ꮫ ㄆド ᴗ⟶⌮ᶵ㛵 •㠀⮫ᗋヨ㦂 •⮫ᗋヨ㦂 䫔ᶨ䧖⋣䗪㨇☐墥忈屑⢚㤕䠄 27B1X00013䠅 ➨✀་⸆ရ〇㐀㈍ᴗ䛂ணᐃ䛃 ◊་ჾ䠄ᰴ䠅 ୰ •≉チㄪᰝ䞉⏦ㄳ •⨨タィ䞉㛤Ⓨ䞉⏕⏘ •䜻䝑䝖㈍ •㈍᥎㐍䞉ಖᏲ䞉䝃䞊䝡䝇 ་⸆ရ䠄యእデ᩿⏝་⸆ရ䛻 㝈䜛䠅〇㐀ᴗチྍ ༊ศ 䠎ྕ 䛂ணᐃ䛃 ୰ 䠄ᰴ䠅䝯䝍䝪䝇䜽䝸䞊 䞁 PL ㈍ ༺ᴗ䚸௦⌮ᗑ •䜻䝑䝖タィ䞉㛤Ⓨ䞉⏕⏘ 㢳ᐈ䠄ᅜෆ䚸ᾏእ䠅
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