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1、*06,+17,1*5,+17,+17,2,1*5+17,2MIVMM)0WZIV,3+17,1*5,+17,+17,+17+17,+-7,+17,+17,1*5,1,1,1,1,4,*06,+17+171*5+172MIVMM)0WZIV,1*5,5,+17,*06,6u,0;,0;,*06,0;,h,hv,+17;IJQVM-MZIM,+17,+17,+17,+17,+17+-7,+-7,+17,+17,+17,!+17,+17,7+17,*06,+171,+17,+17,-,+17,-,g,g,+17,1,8,*06,1,+17,1,+17,+17,1,1,+17,+17,1,9*06,
2、+17,1,1,+17-,+17,10,*06u*06hv*QZOQM,ZM_M CIO,Lgemiddelstyrelsen,Danish Medicines Agency,11*06,+17,12u,*06,vh,:XQVLMZ/WMT,+17)QZMT)NZQKI,8+,58,:.1,-,+17,+17,+17,-,13+17,+17,+-7,*,6,+17,+-7,*06,*06 1,*,6 1,+-7,+17+-7,23456,23456,14,*06,+17,1,*,6,*06,+17,+-7,g,+17,+-7,12345678,12345678,+-7,+-7,+17,15,+
3、17,+17,!,+17g,+17,g,+17,uBWT:IbWQ,+17 53*IVS BZ,vh,100%,h,90%,83%83%,+17,80%70%60%,68%,74%,75%68%,60%,64%60%,71%58%,66%57%,54%55%,!,50%,40%30%20%10%,33%,16,*06,+17,1,u,hv,+17,1,h,0;,+MbIZa 3WM_SQ,+17;STMXa 3WUNWZ;),+17,+17,+17,+17,1,+17,1,+17,1,17,+17,+17,18,*06,CIO,u,vh,CIO,CIO,QUIT/WMT-VMZOa 4L,1,
4、08+4-5QIT,CIO,CIO,CIO,IT,CIOIT,CIO,IT,19+17,+17,+17,+17,20,u,*06,vh,5IIPQSW 3WV,1,;UQWUW 5 4QUQMLu0;*TaKPM;IVQTI AZQMQKP+17/TIZWa,hv,21,1+17,1,152%,+17,1,28%,14%,6%,22,*06,+17,80%70%60%50%,40%,31%,28%,30%20%10%,23%23%,21%,19%,16%16%,14%12%,9%,8%,7%,7%,5%,23,u,:6(,960,960,h,3ITUIV IVPIT,+17 0-/ZWX PM
5、ZUWM,+17,+17,1,+17,+17,+17,+17,24,1,*06,8%10%,18%21%,74%69%,u,vh,+17,+17,+17,QW 7MZW,+17.MZZMaZW;),+17,+17,0;,h,1,+17,25,49%,0;,63%,42%,45%,29%,26,*06,1,1,1,1,1,1,1,1,-:8,27(RaV5VILS1)SbW6WJMT,1,8QMMZ;KPWMPQR1,!,)SbW6WJMT,+171,1,1,1,)SbW6WJMT,-:8,1,28,*06(SSPLK)LLYHNL.YVW)TTQML*MMZIOM/ZWX,!,)TTQML,)
6、TTQML,1,!,*ZQIV 5IZOWTQM,)TTQML,+17,!,1,1,u,1,!,1,*ZQIV 5IZOWTQM/ZWX,1+17,*)TTQML*MMZIOM,)TTQML,5IZOWTQM,?-*,29,1,1,30,*06,u,htv,s,2WPV/TIVQTTM,1LMIT;MTZIL/ZWX 1u,vh,0QZWaSQ AWPQUWW+17,+ITWVQK 3IVMQ+WZXWZIQWV,31,+17,1,+17,+17,27%,1,+17,32%27%,15%,32,*06,u,vh,+17,+17,+PMZaTM 2MVSQVWV,1X_QKP+Qa+WVKQT+
7、17,+17+17,+17,h,1,+17,0;,80%,+17,70%60%50%,62%,60%,58%58%,55%53%53%,52%,51%51%50%,46%45%45%45%,44%43%,40%29%30%20%10%,33,+17,1,+17,u,g0;,h,+17,1,2WPV 5K,MZUW,hvMZW+WZXWZIQWV+17,14%17%,20%18%,66%65%,+17,+17,u,v,1,34,*06,gu,vh,1,5IIPQSW ISMVISI,.ZSI_I;Sa)TUQVU+WZX,+17,+17,2%5%5%,16%,23%25%,82%72%71%,3
8、5,!,+17,h,!,+17,+17,u2WPV 5ZZIa+17-5;-,vh,+17,+17,-,+17,-,+17,+17,36,*06,+17,1,71%,+17,49%,45%,61%,110%29%,37,1,1,1,1,1,38,*06,:)(52,A-;*)63,0;2%,!A-;*)63,!,1,+17,=UMP 2IQV,A-;*)63,1,2IQVA-;*)63,1,!,1,39,40,u,*06,vh,2IXXM*TII_,+17,)QZ.ZIVKM 345,u,hv,5QSM*MVWV,+17,1:-+,41,+17,1,1,14%,+17,+17,26%34%,2
9、7%,42,*06,+17,+17,80%70%60%50%,40%,32%32%32%,30%29%,28%,30%20%,23%22%,20%19%,18%17%17%17%,14%14%13%13%,10%,43,+17,1,u,vh,-,?MJ,:.1,vh3MQV,IJVMa+17?MTT.IZOW?PWTMITM,QQQWV,+17,+17,+17,g+17,44,*06,+17,+17,56%1,70%68%65%,+17,+1780%,75%73%69%,45,+-7,u,h,!,+17,!,+17,vh-LIZLW:QW+17 5)6/7,+17,+17,1%4%,10%,1
10、5%,22%,39%,84%75%51%,46,*06,+17,+1723%,47%,+17,u3MVVa IQ,hv+17 1VMVMK)XXTQIVKM+WZX,58%,+17,+17+17,47,+17,+17,+17,64%,36%,47%,48,*06,1,1,+:5,?MJ,497LLYIVYVNO7XXWZVQa 8MMZJWZWOP 7XXWZVQa 8MMZJWZWOP,7XXWZVQa 8MMZJWZWOP,ZMWZ/QJWV,50,*06LTH)HUR,u,?MUI*IVS,!,?MUI*IVS+17,7TIaQVSI 7VQ,+17,7TIaQVSI 7VQ,1,)5,
11、1,?MUI*IVS,KIP WV PM OW,)5,7VQ?MJ?MUI*IVS,.IKMJWWS,)5,?MJ,.IKM*WWS,?MJ,51,1,52,*06,u,hv,u,hv,2MNNZMa*IZJMI,*IVS+WZXWZIQWV,*;*IVS,IM/TMLPQTT,53,+17,1,1,1,+17,8%14%,26%52%,54,*06,u)VOMTW.QOIZW,+17:MVIT LW*ZIQT,vh,+17,+17,+17,55,80%,70%60%50%,40%,35%,30%20%10%,21%21%20%20%,18%,15%,13%,11%10%10%,9%,9%,9
12、%,7%,6%,5%,3%,g,+17,1,1,+17,56,*06,+17,+17,16%,15%,68%,u,vh,16%,21%,27%+17,24%22%,25%,60%57%47%,2MIV,IVQMT:MVMMa8M 4L,:WKPM,QIOVWQK)QI 8IKQNQK,+17,57,69%,+17,+17,+17,54%,94%,31%,28%,u,60%,AIb lken,);QOWZI,hv+17,+77,+17,+17,!,+17,44%,193%15%,+17,58,*06,594;5,56,56 5WJQTM5WVMa 516,!,5WJQTM5WVMa,0WTTIZ
13、L 1VZIVKM,UQ 4QNM,516,516,+17 2aWQ,MIQ,516,60,*06HYPJR,4WZL 3UIZ*PIIKPIZaaI5IVNIKZQVO/ZWX,?5/,!,?IZ_QKS!?5/,2Ia*IT,?M 5QLTIVL+WTTIJWZIQM,+WUUMZKM 5IZSMXTIKM,*IT,61,e,62,*06,u0;,*06th,s,vhPM+W WXMZIQM/ZWX 1;NWZ.WWL:MIQT5IZS 0ITM,u+PIZTWM 2WVM,hv+17:MTQIVKM 8MZWTMU,*06,+17,63,+17+17,+17,+17,64,*06*06,
14、uUMZQKIV-TMKZQK 8W_MZ,v,+17 8IJTW MOI,+17,+17,1,+17,1,1,+17,+17,+17,+17*06*06*06*06,+17,*06,65,u,s,thv6);)+17 3MTTa+IZMZ,1,-,66,*06,+17,1*5,+17,+17,1*5,+17,8*,+17,+17,+17,1,+17,1,1,1,1,+17,67+17,+17,1,1,+17,+171,1,+17,16%,15%,22%,+17,1*5,43%,6%,26%,35%,12%,25%,68,*06,+17,+17+17,8MMZ 3WZMV,4QVLI*IV,;
15、MXPMV*ITTW3ZQQV*QZWV;UIVI,MJ:WJ/IZZMWV6QQV/QZWZI0MTMV 3Ia5QI 3WIK2TQM 1VTW_ 5VWb2WWVaWVO 4MM3IPTMMV 5IZQV2WVQ 5K,WVITL,IM 5K/WMZV;PIQTMP;QVPIQVKMVIVMI IV LM TQM,-Z_QV MZZIMTMV,4QI?MIZQVO,:WJaV*MVVM:MJMKKI*TMZWV-VOJMZMV5IZS-ZVM:QKP-XWQW/ZMOWZa/WTLMV3+/WWLUIV3MZZQM 0WTTMa+PZQQVM 3QVMZ0IZMa 3WMXXMT8MMZ
16、 3WZMV,*MQV 5IOQZM5I 8WZI:WL;UQP8IZQKS WWTM,5QSM?QVO,+17,1*5,69,1*5,1*5,1*5,1*5,!,70,*06,1*5,+IXQITQbQVO WV+WUXTMQa 1VQOP NZWU PM/TWJIT+PQMN,-MKQM 7NNQKMZ;La,KIXQITQbQVOWVKWUXTMQa,1*5,WQKM WN PM+17 1VQOP NZWU PM/TWJIT+PQMN,1VNWZUIQWV 7NNQKMZ;La+17,!,!WQKMWNPMKQW,1,+,QOQIT=VQMZM;La,-5+,1*5,+IXQITQbQV
17、O WV+WUXTMQa 1VQOP NZWU PM/TWJIT+PQMN,-MKQM 7NNQKMZ;La,KIXQITQbQVOWVKWUXTMQa,)JW)SbW6WJMT,)SbW6WJMT PX _ ISbWVWJMT KWU IJW,;:1 1VMWZ=XLIM;:1,)SbW6WJMT,PX _ ISbWVWJMT KWU aMU QUIOM,)SbW6WJMTG8IZQG;:1GZWILPW_GKU!XLN,)TTQML*MMZIOM/ZWX?MJ,PX _ ITTQMLJMMZIOM KWU,!,8W_MZ;aMU,?MJ,1*5,+75576,1*5 8W_MZ;aMU Q
18、,808?MJ,PX _ JI KWU VM_ 8,.1*5 8W_MZ;aMU Q,?MJ;WTQWV)_IZL NZWU+WUUWV!NWZ 808 JIML?MJQM XLN,A-;*IVS?MJ,PX _ aMJIVS QV QVLM RXVIQOIQWV=ZT%.A-;*IV,S:MXWQWZa.MV.)JW,1*5,+IXQITQbQVO WV+WUXTMQa 1VQOP NZWU PM/TWJIT+PQMN,-MKQM 7NNQKMZ;La,KIXQITQbQVOWVKWUXTMQa,8MMZJWZWOP IQU W JMKWUM=3 IQVIJTM KIXQIT 8MMZJWZ
19、WOP,+TQKS/ZMMV,PX _ KTQKSOZMMV WZO S VM_ VIQWVIT VM_ XMMZJWZWOP IQU W JM S IQVIJTM KIXQIT _QP IUJQQW VM_ XZWRMK PUT,*ZQMN 8ZWNQTM IJW?-5)*IVS XTK,?-5)*IVS,PX _ _MUIJIVS KWU 8IOM+WVMV IXQL%2J1=3*K O 2:A-X 8)8O L L TV%/a=T1 K;2-!?I YLJ.9 L L,PX _ UV KWU,3QU/IZa5WJQTM*IVSQVO QV)NZQKI)V 7MZQM_,PX _ UWJQ
20、TMUIZSMQVOIVLMKPVWTWOa KWU WXXW UWJQTM JIVSQVO QV INZQKI IV WMZQM_,!,-,71,8QWVMMZQVO PM _Ia,516/ZWX,56/PIVI TIVKPM UWJQTM UWVMa QVZIVKM 56/PIVI,VHSLSLJVT,PX _ WITMTM KWU QM_,IX+%1,%3QU/IZa5WJQTM*IVSQVO QV)NZQKI)V 7MZQM_,PX _ UWJQTMUIZSMQVOIVLMKPVWTWOa KWU WXXW UWJQTM JIVSQVO QV INZQKI IV WMZQM_,*MZI
21、;IT)NZQKI 56:IVSML+WVQVMV WX*ZIVL,516,HSS(MYPJH JVT,PX ITTINZQKI KWU WZQM PUT?5/PX _ _IZ_QKS IK S NIK KQ _UO IJW 6QMTMV*MMZTMa,Z 2Ia*IT QZIT-VMZXZQM 6M_WZS LMTQMZ ZMIT ZMZV 2Ia*IT,!,PX,LMQOVIVLQVVWIQWV_U JTWOXW KWU!LMQOVITS LZ RIa JIT LQOQIT TIJ PUT,+17,+17,+17,72,*06,1*5,QQJ(QJU KWU,1*5,1*51*5,QJU KWU,1VMZVIQWVIT*QVM 5IKPQVM+WZXWZIQWV1*5,1*5?MJ,+WXaZQOP IVL ZILMUIZS QVNWZUIQWV1*5,5WPI_S 7XQWV 8+?PQM+WXaZQOP 1*5+WZXWZIQWV)TT:QOP:MMZML+1-+6B0,*,
