- 發文/公布日期：1988-03-15
- 文件類別：公告
- 文號：衛署藥字第718283號
- 分類：安全資訊風險溝通表
- 點閱次數：270
主旨：
- 為配合藥品生體可用率及生體相等性試驗之施行，檢送截至76年12月31日止經
列入監視中新藥成分75種，計147品目之名單一份 (如附件) 請查照。
說明：
- 一、依據本署76.11.27.衛署藥字第700917號公告說明四辦理。
二、嗣後經列入監視中新藥之名單將陸續函告。
附 件：
┌──┬───────────────┬─────────────┬───┐
│核准│ 成 分 名 稱 │ 品 目 │ 監視 │
│編號│ │ │ 期限 │
├──┼───────────────┼─────────────┼───┤
│134 │ACEMETACIN │RANTUDIL 60 MG CAP. │790119│
│ 58 │ACLARUBICIN HCL │ACLACINON INJ. │761027│
│ 28 │ACYCLOVIR │ZOVIRAX OPH. OINT. │750620│
│ 29 │ACYCLOVIR │ZOVIRAX IV. │750620│
│ 49 │ACYCLOVIR │ZOVIRAX TAB. │760730│
│ 80 │ACYCLOVIR │ZOVIRAX CREAM │770607│
│ 67 │ALPRAZOLAM │XANAX TAB. 0.25 MG │761203│
│ 68 │ALPRAZOLAM │XANAX TAB. 0.5 MG │761203│
│ 87 │ALPRAZOLAM │XANAX TAB. 1 MG │761203│
│ 82 │AMBROXOL HCL │MUCOSOLVAN LIQ. 3 MG/ML │790119│
│ 71 │AMBROXOL HCL │MUCOSOLVAN TAB. 30 MG │790119│
│121 │AMRINONE LACTATE │INOCOR LACTATE INJ. │781022│
│ 57 │ASTEMIZOLE │HISMANAL │761011│
│ 94 │ASTEMIZOLE │HISMANAL ORAL SUSP.1 MG/ML│761011│
│ 70 │ATRACURIUM BESYLATE │TRACRIUM INJ. │770114│
│ 59 │AURANOFIN │"RIDAURA" TILTAB TAB. 3MG │761106│
│147 │BETAXOLOL HCL │BETOPTIC STERILE OPH. SOLN│790910│
│135 │BIFONAZOLE │MYCOSPOR CREAM │790304│
│ 1 │CAPTOPRIL │CAPOTEN TAB. 25 MG │740722│
│ 2 │CAPTOPRIL │CAPOTEN TAB. 50 MG │740722│
│ 3 │CAPTOPRIL │CAPOTEN TAB. 100 MG │740722│
│132 │CARTEOLOL HCL │ARTEOPTIC 2% OPH. SOLN. │781211│
│133 │CARTEOLOL HCL │ARTEOPTIC 1% OPH. SOLN. │781211│
│ 77 │CEFMENOXIME HEMIHYDROCHLORIDE │BESTCALL IV. 1 GM │770524│
│ 79 │CEFMENOXIME HEMIHYDROCHLORIDE │BESTCALL IM. 0.5GM │770524│
│ 78 │CEFMENOXIME HEMIHYDROCHLORIDE │BESTCALL IV. 0.5 GM │770524│
│ 84 │CEFONICID SODIUM │MONOCID 1 GM INJ. │771001│
│ 85 │CEFONICID SODIUM │MONOCID 500 MG INJ. │771001│
│131 │CEFOTETAN 0.25 GM,IV │YAMATETAN FOR IV INJ.0.25G│781215│
│128 │CEFOTETAN 0.5 GM,IM │YAMATETAN FOR IM INJ.0.5 G│781215│
│130 │CEFOTETAN 0.5 GM,IV │YAMATETAN FOR IV INJ.0.5 G│781215│
│129 │CEFOTETAN 1 GM,IV │YAMATETAN FOR IV INJ. 1 G │781215│
│ 7 │CEFOTIAM 2HCL │PANSPORIN IV. 0.5 GM │741006│
│ 8 │CEFOTIAM 2HCL │PANSPORIN IM. 1 GM │741006│
│ 9 │CEFOTIAM 2HCL │PANSPORIN IM 0.25 GM │741006│
│118 │CEFROXADINE │ORASPOR 250 MG CAP. │780829│
│119 │CEFROXADINE │ORASPOR 125 MG CAP. │780829│
│ 10 │CEFSULODIN SODIUM │TAKESULIN IV. 0.5 GM │741006│
│ 11 │CEFSULODIN SODIUM │TAKESULIN IM. 0.5 GM │741006│
│ 89 │CEFTAZIDIME │FORTUM FOR INJ. 500 MG │771204│
│ 90 │CEFTAZIDIME │FORTUM FOR INJ. 2 GM │771204│
│ 96 │CEFTAZIDIME │FORTUM INJ. IV.INFUSION 2G│771204│
│ 39 │CEFTIZOXIME SODIUM │EPOCELIN FOR IM. 0.5 GM │751122│
│ 40 │CEFTIZOXIME SODIUM │EPOCELIN FOR IV. 1 GM │751122│
│ 42 │CEFTIZOXIME SODIUM │EPOCELIN FOR IM. 0.25 GM │751122│
│ 41 │CEFTIZOXIME SODIUM │EPOCELIN FOR IV. 0.5 GM │751122│
│107 │CEFTRIAXONE DISODIUM │ROCEPHIN FOR IV. 1 GM │780520│
│104 │CEFTRIAXONE DISODIUM │ROCEPHIN FOR IV. 2 GM │780520│
│105 │CEFTRIAXONE DISODIUM │ROCEPHIN FOR IV. 250 MG │780520│
│106 │CEFTRIAXONE DISODIUM │ROCEPHIN FOR IV. 500 MG │780520│
│108 │CEFTRIAXONE DISODIUM │ROCEPHIN FOR IM. 1 GM │780520│
│112 │CEFTRIAXONE DISODIUM │ROCEPHIN FOR IM. 500 MG │780520│
│113 │CEFTRIAXONE DISODIUM │ROCEPHIN FOR IM. │780520│
│ 20 │CICLOPIROX OLAMINE │BATRAFEN SOLN. │750510│
│ 21 │CICLOPIROX OLAMINE │BATRAFEN CREAM │750510│
│150 │CLOBETASONE BUTYRATE 0.5 MG/GM│EUMOVATE OINT. │791208│
│ 62 │CYCLOSPORIN SANDIMMUN DRINK SOLN 100MG/ML│761127│
│ 63 │CYCLOSPORIN │SANDIMMUN CONC. FOR IV INJ│761127│
│ 30 │DESMOPRESSIN ACETATE 3H2O │MINIRIN DDAVP INTRANASAL RESORPTION
│ │ │ │750630│
│ 44 │DESMOPRESSIN ACETATE 3H2O │MINIRIN DDAVP INJ. 4UG/ML │751116│
│139 │ENALAPRIL MALEATE │RENITEC TAB. 20 MG │790309│
│142 │ENALAPRIL MALEATE │RENITEC TAB. 10 MG │790309│
│143 │ENALAPRIL MALEATE │RENITEC TAB. 5 MG │790310│
│148 │ENOXACIN │FLUMARK F.C. TAB. 100 MG │791008│
│149 │ENOXACIN │FLUMARK F.C. TAB. 200 MG │791008│
│ 93 │EPIRUBICINE │PRARMORUBICIN INJ. 10 MG │771228│
│ 95 │EPIRUBICINE │PRARMORUBICIN INJ. 50 MG │771228│
│ 47 │ESTRAMUSTINE PHOSPHATE │ESTRACYT CAP. 140 MG │760620│
│ 98 │ETOPOSIDE │VAPESID IV INFUSION 100 MG│780224│
│144 │ETOPOSIDE │VAPESID CAP. 50 MG │790420│
│145 │ETOPOSIDE │VAPESID CAP. 100 MG │790420│
│ 24 │ETRETINATE │TIGASON CAP. 10 MG │750603│
│ 25 │ETRETINATE │TIGASON CAP. 25 MG │750603│
│122 │FAMOTIDINE │GASTER TAB. 20 MG │781024│
│140 │FAMOTIDINE │GASTER INJ. │790328│
│102 │FENOFIBRATE │LIPANTHYL CAP. │780224│
│141 │FLUTAMIDE │FUGEREL TAB. │790414│
│ 33 │FOSFOMYCIN SODIUM │FOSMICIN FOR INJ. 2 GM │750902│
│ 48 │FOSFOMYCIN SODIUM │FOSMICIN FOR INJ. │750902│
│ 54 │GEMFIBROZIL │LOPID CAP. 300 MG │780730│
│ 23 │GUANFACINE HCL │ESTULIC TAB. 1 MG │750523│
│ 43 │GUANFACINE HCL │ESTULIC TAB. 2 MG │750523│
│ 97 │GUANFACINE HCL │ESTULIC TAB. 0.5 MG │750523│
│103 │INDORAMINE │WYDORA TAB. 50 MG │780428│
│114 │INDORAMINE │WYDORA TAB. 25 MG │780428│
│ 91 │IOHEXOL │OMNIPAQUE 300 MG/I/ML │771210│
│ 92 │IOHEXOL │OMNIPAQUE 350 MG/I/ML │771210│
│116 │IOPAMIDOL │IOPAMIRE 200 │770115│
│137 │IOPAMIDOL 300 │IOPAMIRE 300 │770115│
│138 │IOPAMIDOL 370 │IOPAMIRE 370 │770115│
│109 │ISOTRETINOIN │ROACCUTANE SOFT CAP. │780604│
│110 │ISOTRETINOIN │ROACCUTANE SOFT CAP. │780604│
│111 │ISOTRETINOIN │ROACCUTANE SOFT CAP. │780604│
│ 37 │KETAZOLAM │SOLATRAN CAP. 15 MG │751121│
│ 38 │KETAZOLAM │SOLATRAN CAP. 30 MG │751121│
│ 16 │KETOCONAZOLE │NIZORAL TAB. 200 MG │741223│
│117 │KETOCONAZOLE │NIZORAL CREAM │800827│
│ 12 │LATAMOXEF SODIUM │SHIOMARIN IV. INJ 250 MG │741014│
│ 13 │LATAMOXEF SODIUM │SHIOMARIN IV. INJ 500 MG │741014│
│ 14 │LATAMOXEF SODIUM │SHIOMARIN IV. INJ 1 GM │741014│
│ 15 │LATAMOXEF SODIUM │SHIOMARIN IM. INJ 500 MG │741014│
│126 │LEUPROLIDE ACETATE │LUPRON │781204│
│ 73 │LISURIDE HYDROGEN MALEATE │DOPERGIN │770130│
│101 │MEDROGESTONE │COLPRONE TAB. │780418│
│ 65 │MEGLUMINE IOGLICATE │RAYVIST 180 │761130│
│ 66 │MEGLUMINE IOGLICATE │RAYVIST 300 │761130│
│ 74 │MEGLUMINE IOGLICATE │RAYVIST 350 │761130│
│ 81 │MESNA │UROMITEXAN INJ. │770619│
│ 35 │METRIZAMIDE │AMIPAQUE 3.75 GM │750919│
│ 36 │METRIZAMIDE │AMIPAQUE 6.75 GM │750919│
│ 83 │MITOXANTRON │NOVANTRONE INJ │770913│
│ 31 │MOPERONE HCL │LUVATRENE TAB. 5 MG │750708│
│ 32 │MOPERONE HCL │LUVATRENE RETARD TAB. │750708│
│ 4 │NETILMICIN SULFATE │NETROMYCIN INJ. 25MG/ML │741005│
│ 5 │NETILMICIN SULFATE │NETROMYCIN INJ. 50MG/ML │741005│
│ 6 │NETILMICIN SULFATE │NETROMYCIN INJ. 100 MG/ML │741005│
│124 │NICARDIPINE HCL │PERDIPINE TAB. 20 MG │781117│
│125 │NICARDIPINE HCL │PERDIPINE TAB. 10 MG │781117│
│ 69 │NORETHISTERONE OENANTHATE │NORISTERAT │761217│
│ 72 │NORFLOXACIN │BACCIDAL TAB. │770125│
│ 34 │PENBUTOLOL SULFATE │BETAPRESSIN F.C. TAB. │750824│
│ 99 │PIRPROFEN │RENGASIL CAP. 200 MG │780314│
│100 │PIRPROFEN │RENGASIL CAP. 400 MG │780314│
│ 19 │PIZOTIFEN HYDROGEN MALEATE │SANDOMIGRAN S.C. TAB │750425│
│ 52 │POTASSIUM CLAVULANATE │AUGMENTIN DISP. TAB 375MG │760907│
│ 53 │POTASSIUM CLAVULANATE │AUGMENTIN TAB. 375MG │760907│
│115 │POTASSIUM CLAVULANATE │AUGMENTIN SYRUP │780716│
│ 88 │PROCATELOL HCL │MEPTIN LIQ. │761009│
│ 55 │PROCATELOL HCL HEMIHYDRATE │MEPTIN-MINI TAB. │761009│
│ 56 │PROCATELOL HCL HEMIHYDRATE │MEPTIN TAB. │761009│
│ 26 │RANITIDINE HCL │ZANTAC TAB. │750603│
│ 27 │RANITIDINE HCL │ZANTAC INJ. │750729│
│ 86 │RANITIDINE HCL │ZANTAC TAB. 300 MG │750603│
│ 45 │ROSOXACIN │ERADACIL CAP. │760510│
│ 50 │SODIUM MECLOFENAMATE │MECLOMEN CAP. 100 MG │770323│
│136 │TENIPOSIDE │VUMEN IV. INFUSION │790309│
│ 64 │TERFENADINE │TELDANE TAB. │761130│
│120 │TERFENADINE │TELDANE SUSPENSION │761130│
│ 51 │TIOCONAZOLE │TROSYD DERMAL CREAM 1% │780515│
│ 46 │TOLFENAMIC ACID │CLOTAN CAP. 100 MG │760511│
│146 │TRAMADOL HCL │TRAMAL 50 INJ. │790827│
│127 │TRIGLYCYL LYSINE VASSOPRESSIN │GLYPRESSIN 1 MG │781208│
│123 │TRILOSTANE │TRIWINOL CAP. │781009│
│ 61 │TROMANTADINE HCL │VIRU-MERZ SEROL │761109│
│ 17 │VANCOMYCIN HCL │VANCOCIN HCL IV. INJ. │750331│
│ 18 │VANCOMYCIN HCL │VANCOCIN HCL ORAL SUSP. │750702│
│ 60 │VECURONIUM BROMIDE │NORCURON INJ. │761107│
└──┴───────────────┴─────────────┴───┘