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医療機器の添付文書の記載要領に関するQ&Aについて [PDFファイル

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Contents

1.
2. 2 Q39 3 A39 0 7 MM Q40 AN IS ET
3. 11 MR Q50 A50 1 2 9 3 2
4. A22 A Aa BED RG 6 YA 4 3 1 ONO RR 8 0 A23
5. KM NN MM NR 2 a _ A37 II ce I EE ER A38 1
6. i A24 Q23 _5 WRN NOS ANN AT ES PAA ASN RR at oR Nt oda RAN A NEN ANTE RIRS T
7. A18 AU 3 A19 A20
8. Q amp A A68 i Ye TT CC OE OR oo 3 A69 1 NR A70
9. A33 1 NE NN Me A34 2 1 A35 NE a A36
10. 5 10mL F Q28 A28 1 UN 2 A29 A30 A3 1 2 3 O 3 2 6
11. RR I Se RR CC Ce oN gt I 1 Ne 3 8 1 2 2 6
12. A _ 6 A 7 Q amp A A 2 RO EE 1 0 A EM a 3 2 Ei 9 LAN RS 9 Q amp A A 3 3 Q 9 1 1 2
13. 3 5 12 Q51 3 6 3 A51 _18 RCC AS RI A AES INITIATING TAA NAVAS AS eS oA a oi 00D DD AAO A A A rst PRK YIO seta Noa ANAC NAD ID AR I Uk hatet eB Eten oe 0GHRBU NERS NIAAA TAI OE NI SAE SR ER HABR ot Gioe Zagteit oti dott A MO OIRO RISA RAAT EET RS RS ED
14. 1 13 1 Re RO 1 Se E 0 lt i EO 1 AA 2 1 3
15. PTCA
16. Ae A43 RN i SE A 2 CS A44 F 2 15 A45
17. 26 10 31 1031002 1031002 0 Q amp A 0 63 2 6 A 1 63 2 63 2 RO i Ni
18. A66 1 JMDN OO AB 123C i 3 7 SN 2 RR i ee NN A67
19. gt A57 A58 Q59 A59 Q60 A60 PMDA A61 EMI Ss 17
20. A73 1 1 2 22 Q74 REP 1 YET SS PT A Q75 A75 1
21. O 2 1 1 3 5 6 7 8 9 10 11 12
22. 2 2 1 TV a _ i 2
23. 00 1 14 21 Nt Z a i IT TT EE PIT TTT TT ET mwwew wrmrtt eto eo 2 2 FF
24. RN RR RR A55 5 fT 1 2 A56 O 15 3 Q57 3 10 2 1069
25. 10 47 6 1 495 2 TTT A RON ER 2 1 di ON a OO i CO IN CN UD CR Ot A z 1 2 2 Se _
26. MR NA WRN ote one Ne I yA ELAINE I AR Q46 A46 2 8 NR B OE ON 9 A47 10 20CWANSSGCQOWAYN012900ReWO Q48 A48
27. PC ht CO 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32
28. A62 URL 2 23 2 3 1 Re 4 i gt J o ON A63 18 Sis i RA A 3 A64 4208009 13 Q65 A65 RD A RN
29. 1 7 Q amp A 1 1 0 A 4 A71 A4 12 Q amp A OR IA 21 AA NIDA A NAMIE Sr ir MA SUI ded AA AOA SS I RA CN ome Ge edie oto ALLS olote dailoysess Ire dotted snideas osesn2ietEIISiE ESSELTE NE ES Ell SSSA EEO RAIA Db hbasabooe tdb gs do Nin EIU Rt ERI RA Std BOS Ia SIIENE A et ia bce ARGS Q73 BE 1 12 1
30. 26 10 31 Q amp A 26 10 2 1002 8 1002 1 1002 5 Q A 24 10 26
31. g 3 EMR A12 A13 3 Al4 Al5 Al6 27 4 8 0 RON RR A4 4 4
32. 1 5 RN a 7 9 i 0 E SC 6 3 A17 Oak p
33. I 0 N i ie A 3 Q27 A27 6 5 i even toi REC 9 8 DN
34. Q 3 1 Q amp A A 2 2 4 Ns 0 A _ 4 Q amp A A 2 A 3 gt A 5
35. Q amp A QA 25 84 8 A 8 26 10 2 1002 8 2 M0 5203 26 10 2 1002 1 26 10 2 1002 5
36. 49 X RIN Nt ON OO TOCT TN ZT TN TTT TTT OT OT TOP TORONTO TTS 8
37. A40 i A41 A42
38. IRA IARI Ronit te Q52 A52 Q53 A53 14 TOR ONTANASS APNE8 sSNA GRANIAANRRIRGERARND dA Rr NILE ORIG ASOT UE da RE bt CRAIGS EDOE SPREEAESRECD GSE OIG TCEN VANONIOIENONAIA TRS INABAG NLL RRA RNA ALE STIPE ot bar UNS RD SAA IAG ELIS AN EANAA SANIT dgSENER EBA SAE NO PAGSNS BRANES ee in NI Ps Q54 A54
39. ANTAIA TNS NA NE OAI EEE SHEETINGASSS EYER SI AR SA ERNENS RS NTRS CANE SAAN ASA Id NFER WRASSE RINT At RAATK OER IT ANNA DNA AG ER AA EER EY RE RS ir RN EY A St area ia Q25 A25 lt lt SS 6 w TRY TP eeeINNI0iaAAATteMthPneYeYA 2 MG sR dye gaa tae oR A Shees taneyeosee ts Wt a doses NA AANA A OYA ttn st Nt tt te te DAA OKANAGAN SAAR NITE ETARE IRR A26 i

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