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1 DA DA Talk Paper2004/03/02 DA Plans to Evaluate Results of Women's ealth Initiative Study for Estrogen-Alone Therapy DA WI estrogen Iational Institutes of ealthwi estrogen estrogen estrogen Estrogen estrogen Estrogen 11,000 WI estrogen+progestin Estrogen+progestin DA WIMSWI memory substudy65 estrogen+progestin Estrogen+progestin DA Estrogen estrogen+progestin WI WIMS DA estrogen estrogen+progestin DA estrogen 1
2 DA estrogen estrogen DA DA I estrogen 2 DA a 3 S C 3 a 3 S C 3 a 3 S Conjugated Estrogens C 3 C 3 3 C C 3 3 C C 3 Medroxyprogesterone Acetate / PhaseIII 2003/ /03/11 2. DA ews2004/03/03 DA Launches ew Easy-to-Use Drug Information Web Site DADA DAhttp:// TC DACDER 2
3 DA Mark B. Mcellan DA CDER DA TC 3. MedWatchweb 2004/03/03 Summary View: Safety Labeling Changes Approved By DA Center for Drug Evaluation and ResearchCDERDecember 2003 CCTRAIDICATISBWBXED WARIG WWARIGSPPRECAUTISARADVERSE REACTIS C BW W P AR Estradiol Valerate Injection Delestrogen Demeclocycline ydrochloride Declomycin Tablets Sodium Polystyrene Sulfonate Kayexalate Powder Lidocaine ydrochloride and 5% Dextrose Injection Lidocaine ydrochloride and 5% Dextrose Injection Tazarotene Tazorac Gel 3
4 Theophylline in 5% Dextrose Injection Theophylline in 5% Dextrose Injection C BW W P AR evirapine Viramune Tablets and ral Suspension luorauracil Cream Carac ozapine ozaril Tablets Escitalopram xalate Lexapro Tablets and ral Solution Estradiol and orgestimate Prefest Tablets 3% Amino Acid and 3% Glycerin Injection with Electrolytes ProcalAmine Thioguanine Tabloid Tablets Topiramate Topamax Tablets and Sprinkle Amoxicillin Capsules, Tablets, Chewable Tablets, and Powder for ral Suspension Capsules Amoxil Triamcinolone Acetonide Azmacort Inhalation Aerosol Terbutaline Sulfate Bethine Injection and Tablets Cefadroxil Monohydrate Duricef Capsules and ral Suspension Erythromycin Delayed-Release Eryc Capsules Diflorasone Diacetate Cream lorone Dalteparin Sodium Injection ragmin Imatinib Mesylate Gleevec Tablets Saquinavir Mesylate Invirase Capsules Lopinavir/Ritonavir Kaletra Capsules and ral Solution Leuprolide Acetate Lupron Injection Atovaquone and Proguanil ydrochloride Malarone Tablets and Pediatric Tablets Busulfan Myleran Tablets Triamcinolone Acetonide asacort AQ asal Spray Ciclopirox Penlac ail Lacquer Topical Solution Pantoprazole Protonix Delayed-Release Tablets 0.9% Sodium Chloride Injection 0.9% Sodium Chloride Injection Voriconazole Vfend I.V., Tablets, and ral Suspension 4
5 C BW W P AR Iodixonal Visipaque Injection rlistat Xenical Capsules Azithromycin Zithromax Tablets and ral Suspension Mometasone uroate Monohydrate asonex asal Spray Montelukast Sodium Singulair Tablets, Chewable Tablets, and ral Granules 4. MedWatchweb 2004/03/11 Summary View: Safety Labeling Changes Approved By DA Center for Drug Evaluation and ResearchCDERJanuary 2004 CCTRAIDICATISBWBXED WARIG WWARIGSPPRECAUTISARADVERSE REACTIS C BW W P AR Synthetic Conjugated Estrogens, A Cenestin Tablets Estradiol Transdermal System imara Amino-Acid, Electrolyte, and Glucose Infusion inimix - Sulfite ree inimix E - Sulfite ree Injection Chlorpropamide Diabinese Tablets orethindrone Estradiol Tablets Acetate/Ethinyl emhrt Estradiol Vivelle Estradiol Vivelle-Dot Methotrexate Sodium for Injection Methotrexate Sodium Injection Methotrexate Sodium for Injection Methotrexate Sodium Injection Aspirin/Extended-Release Aggrenox Capsules Dipyridamole Cefazolin for Injection Ancef 5
6 C BW W P AR Pamidronate Disodium Injection Aredia Celecoxib Celebrex Capsules indamycin ydrochloride Capsules indamycin Injection indamycin Injection, in 5% Dextrose eocin eocin Phosphate Sterile Solution eocin Phosphate IV Sterile Solution Indinavir Sulfate Crixivan Capsules xaliplatin Eloxatin for Injection Cephalexin Keflex Pulvules Lamotrigine Lamictal Tablets and Chewable Dispersible Tablets Terbinafine ydrochloride Tablets Lamisil Busulfan Myleran Tablets Amlodipine Besylate orvasc Tablets xiconazole itrate xistat Cream and Lotion Promethazine ydrochloride and Dextromethorphan ydrobromide Phenergan with Dextromethorphan Syrup Pantoprazole Protonix Delayed-Release Tablets Albuterol Sulfate Proventil A Inhalation Aerosol Modafinil Provigil Tablets Silver Sulfadiazine Cream Silvadene Cream Gatifloxacin Tequin Tablets and Injection Didanosine Videx Chewable/Dispersible Tablets Videx Buffered Powder for ral Solution Videx Pediatric Powder for ral Solution Videx Delayed-Release Capsules Enteric Coated Beadlets Azithromycin for Injection Zithromax IV Azithromycin Zithromax for ral Suspension and Linezolid Desloratadine Desloratadine Disintegrating Rapidly Tablets Zyvox IV Injection, Tablets and ral Suspension arinex Tablets arinex Reditabs Tablets Tolterodine Tartrate Detrol Tablets Tolterodine Tartrate Detrol LA Extended Release Capsules Aprepitant Emend Capsules Levonorgestrel Implants orplant System Paroxetine ydrochloride Paxil CR Controlled-Release Tablets 6
7 C BW W P AR Pantoprazole Sodium Protonix I.V. for Injection Zolmitriptan Zomig and Zomig-ZMT Tablets 5. CDER2004/03/16 Summaries of Medical and inical Pharmacology Reviews of Pediatric Studies as of March 16, 2004 Alendronate osamax Merck Atovaquone and Proguanil Malarone GlaxoSmithKline Benazepril Lotensin ovartis Budesonide Pulmicort AstraZeneca Ciprofloxacin Ciloxan Alcon Esmolol Brevibloc Baxter entanyl Duragesic ALZA exofenadine Allegra Aventis ludarabine ludara Berlex luticasone lonase GlaxoSmithKline luticasone lovent GlaxoSmithKline osinopril Monopril Bristol-Myers Squibb Glyburide and Metformin Glucovance Bristol-Myers Squibb Leflunomide Arava Aventis floxacin cuflox Allergan rlistat Xenical offmann-la Roche xybutynin Ditropan Johnson &Johnson Temozolomide Temodar Schering Topotecan ycamtin GlaxoSmithKline Venlafaxine Effexor Wyeth Ayerst web 7
8 6. Subject: Worsening Depression and Suicidality in Patients being Treated with Antidepressant Medications2004/03/22 DA [ Prozac ] fluoxetine [ Zoloft ] sertraline[ Paxil ]paroxetine[ Luvox ] fluvoxamine[ Celexa ]citalopram [ Lexapro ]escitalopram[ Wellbutrin ]bupropion[ Effexor ]venlafaxine[ Serzone ] nefazodone[ Remeron ]mirtazapine DA DA 8
9 [ Prozac ]fluoxetine [ Prozac ]fluoxetine [ Zoloft ] sertraline[ Luvox ] fluvoxamine PDACPsychopharmacological Drugs Advisory Committee Peds ACPediatric Subcommittee of the Anti-Infective Drugs Advisory Committee 2 DA DA Talk Paper DA Public ealth Advisory DA DA PDAC Peds AC DA 9 C 3 C 3 luoxetine ydrochloridessriphase III 2003/05/16 Sertraline ydrochloride SSRI2003/12/ C3 C 2 2 C 2 Paroxetine ydrochloride SSRI luvoxamine MaleateSSRI 9
10 C C 3 C3 C C 3 C 3 Br C 2 C 2 Citalopram ydrobromidessri Phase II 1996/ /03/11 3 C C 3 C 3 C 3 Bupropion ydrochloride Phase I /03/10 3 C efazodone ydrochloride Serotonin 2antagonist/reuptake inhibitorsari Phase II 2003/08/ /03/10 Escitalopram oxalate, SSRI Phase I 2004/04/08 3 C C 3 C3 Venlafaxine ydrochloridesri Phase III2003/11/28 3 C Mirtazapineoradrenergic and Specific Serotonergic Antidepressant assa 2004/03/10 7. DA Talk Paper2004/03/22 DA Issues Public ealth Advisory on Cautions for Use of Antidepressants in Adults and Children DA Public ealth Advisory 10
11 [ Paxil ]paroxetineda DA DA 10 bupropioncitalopramfluoxetinefluvoxaminemirtazapine nefazodoneparoxetinesertralineescitalopram venlafaxine [ Prozac ]fluoxetine [ Zoloft ]sertraline [ Prozac ]fluoxetine[ Luvox ]fluvoxamine[ Luvox ] (fluvoxamine) DA PDAC Peds AC DA DA Public ealth Advisory Talk Paper T03-70 DA Public ealth Advisory DA DA 11
12 8. MedWatchWeb 2004/03/ /03/ Safety Alert: Zyprexa olanzapine Re: Safety data on [Zyprexa]olanzapine yperglycemia and Diabetes Eli Lilly and Company [ Zyprexa ] olanzapine DA Lilly [ Zyprexa ] [ Zyprexa ][ ozaril ] clozapineovartis [ Risperdal ]risperidonejanssen [ Seroquel ]quetiapine AstraZeneca [ Geodon ] ziprasidonepfizer [ Abilify ]aripiprazolebristol Myers Squibb tsuka American Pharmaceutical [ Zyprexa ] [ Zyprexa ]
13 S C 3 C 3 lanzapine MARTAmulti acting receptor targeted agents C 3 ozapinemarta multi acting receptor targeted agents 2004/04/08 C 3 RisperidoneSDA serotonin-dopamine antagonist S 2 2 C C 2 Quetiapine umaratemartamulti acting receptor targeted agents S Ziprasidone ydrochloride ydrate SDAserotonin-dopamine antagonist Phase II 2004/04/08 Aripiprazole 2004/04/08 9. MedWatchweb 2004/03/23 Summary View: Safety Labeling Changes Approved By DA Center for Drug Evaluation and ResearchCDERebruary
14 CCTRAIDICATISBWBXED WARIG WWARIGSPPRECAUTISARADVERSE REACTIS C BW W P AR Sulfadoxine and Pyrimethamine ansidar Tablets Methadone ydrochloride Injection Methadone ydrochloride Injection 200mg Ibuprofen Advil Liqui-Gels Advil Migraine Capsules Dextrose Injections Dextrose Injections Trandolapril Mavik Tablets Zoledronic Acid Zometa Injection Risedronate Sodium Actonel Tablets Etidronate Disodium Didronel Tablets Coated Doxycycline yclate Pellets Doryx Ethacrynic Acid Edecrin Tablets Ethacrynate Sodium Intravenous Sodium Edecrin Erythromycin Base Eryc Delayed-Release Capsules Alendronate Sodium osamax Tablets osamax ral Solution rda rigin Glucagon for Injection ydroxyurea Capsules ydrea Cromolyn Sodium Inhalation Intal Inhaler Aerosal Cromolyn Sodium Inhalation Intal ebulizer Solution Solution Manganese Chloride Injection Manganese Chloride Injection Phytonadione Mephyton Tablets Mexiletine ydrochloride Mexitil Capsules Mechlorethamine for Injection Mustargen Cyclosporine Capsules Cyclosporine ral Solution eoral Soft Gelatin Capsules eoral ral Solution Modified Erythromycin Ethylsuccinate and Pediazole ral Suspension Sulfisoxazol Acetyl for ral Suspension Sevelamer ydrochloride Renagel Tablets and Capsules Cyclosporine Injection Cyclosporine ral Solution Cyclosporine Soft Gelatin Capsules Sandimmune Injection Sandimmune ral Solution Sandimmune Soft Gelatin Capsules Acrivastine and Pseudoephedrine Semprex-D Capsules Ivermectin Stromectal Tablets edocromil Sodium Tilade Inhaler Voriconazole Agenerase Capsules and ral Solution Vfend I.V. for Injection Vfend Tablets and ral Suspension Agenerase Capsules and ral Solution 14
15 C BW W P AR Cilostazol Pletal Tablets CDER2004/03/29 Summaries of Medical and inical Pharmacology Reviews of Pediatric Studies as of March 29, 2004 Medical inical Pharmacology Alendronate osamax Merck Atovaquone and Proguanil Malarone GlaxoSmithKline Benazepril Lotensin ovartis Budesonide Pulmicort AstraZeneca Ciprofloxacin Ciloxan Alcon Ciprofloxacin Cipro Bayer Esmolol Brevibloc Baxter enoldopam Corlopam Abbott entanyl Duragesic ALZA exofenadine Allegra Aventis ludarabine ludara Berlex luticasone lonase GlaxoSmithKline luticasone lovent GlaxoSmithKline osinopril Monopril Bristol-Myers Squibb Glyburide and Metformin Glucovance Bristol-Myers Squibb Leflunomide Arava Aventis elfinavir Viracept Agouron orgestimate and Ethinyl RT Johnson & Johnson Estradiol TRI-CYCLE floxacin cuflox Allergan rlistat Xenical offmann-la Roche xybutynin Ditropan Johnson &Johnson Temozolomide Temodar Schering Topotecan ycamtin GlaxoSmithKline Venlafaxine Effexor Wyeth Ayerst web 15
16 11. DA MedWatchWeb 2004/04/ /03/ Safety Alert : [Abilify]aripiprazole DA [Abilify]aripiprazole [Abilify] [Abilify] [Abilify] [Abilify] [Abilify] [Abilify] [Abilify] [Abilify][Abilify] 1 1kg MS TD [Abilify] aripiprazole [Abilify] [Abilify] 0.1 [Abilify] 16
17 [Abilify] 10 [Abilify] 32% vs 25%25% vs 24%24% vs 19% 14% vs 10%12% vs 7%11% vs 8%11% vs 7% 10% vs 7%10% vs 8% Aripiprazole 2004/04/08 17
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Vol.1 o.38 (2003. 12.26) IGIV FDA.1 2003 12 17 FDA.4 Ciprofloxacin.4 floxacin.5 rlistat.7 - Health Canada.9 - Health Canada.10 Health Canada.10 MHRA FDA 1. Immune Globulin Intravenous (Human) (IGIV); Required
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Vol.2 No.12 (2004/06/24) I [ Crestor ] rosuvastatin 40mg MHRA.2 domperidone FDA FDA.2 [ Crestor ] rosuvastatin FDA FDA.3 2004 6 9 FDA.4 Health Canada SSRI Health Canada.5 SSRI Health Canada.6 Australian
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Vol.2 o.8 (2004/04/22) 2004 [ Clozaril ] clozapine DA.1 2004 [ Abilify ] aripiprazole DA.3 ealth Canada.4 Canadian Adverse Reaction ewsletter Vol.14 o.2 April 2004 ealth Canada Sterol sterolin.5 2003.6.7.8
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医薬品安全性情報 Vol.1 o.19 (2003. 8. 15) 国立医薬品食品衛生研究所安全情報部 目次各国規制機関情報 FDA/CDER による安全性に関する表示改訂の概要 (2003 年 3 月 ) 米 FDA p.1 更新: 潜伏結核感染の rifampin,pyrazinamide 併用療法に関する有害事象データおよび米国胸部学会 /CDC の勧告 米 CDC p.3 ホルモン補充療法の専門家諮問グループ代表によるアドバイス
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Vol.1 o.20 (2003. 8. 22) RT Million Women Study MRA.1 pyrazinamide rifampin FDA.4 FDA/CDER 2003 4 FDA.4 Salmeterol FDA.9 ADEC TGA.10 MRA 2003.8.8 ormone replacement therapy RTand breast cancer results
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23 3 23 3 15 3.7 21 44,612 22 46,28 3.4 21 1,185 22 1,53 9,283 2 4,435 6 8.1 21 35,956 22 38,864 67.1 21 379 22 633 12,745 2.6 1.1 No.84 15 6 24 1 11 1 21 22 3.2 1.4 2291 22 4 2 5 15 1 6 5 1998 1999 11
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Vol.2 o.10 (2004/05/27) MRA.1 [ Desyrel ] trazodone hydrochloride FDA.2 [ Zelnorm ] tegaserod hydrogen maleate ealth Canada.3 ealth Canada.5 [ Viread ] tenofovir disoproxil fumarate ealth Canada.5 [ rthoclone
医薬品安全情報Vol.3 No.8 (2005/04/28)
Vol.3 No.8 2005/04/28 [ Bextra ] valdecoxib MHRA.1 FDA COX-2 NSAID FDA.2 FDA NSAID FDA.6 FDA.7 2005 [ Trileptal ] oxcarbazepine FDA.8 FDA/CDER 2005 2 FDA.9 gefitinib NIH.11 Health Canada [ Bextra ] valdecoxib
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医薬品安全性情報 Vol.1 No.13(2003. 7. 04) 国立医薬品食品衛生研究所安全情報部 目 次 各国規制機関情報 小児臨床試験の医学的および臨床薬理学的評価の概要より(Budesonide) 米 FDA p.1 FDA/CDER による安全性に関する表示改訂の概要 (2003 年 1 月 ) 米 FDA p.2 Miconazole と warfarin の相互作用に対する注意を喚起
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Vol.3 No.3 2005/02/10 Co-proxamol paracetamol/dextropropoxyphene MHRA.1 2005 1 28 FDA.3 FDA/CDER 2004 11 FDA.3 MCI[ Reminyl ] galantamine Health Canada.5 [ Lariam ] mefloquine Health Canada.5 [ Humira
Kobe University Repository : Kernel タイトル Title 著者 Author(s) 掲載誌 巻号 ページ Citation 刊行日 Issue date 資源タイプ Resource Type 版区分 Resource Version 権利 Rights DOI JaLCDOI URL グローバル市場における後発医薬品との競争 : 内資系大手製薬企業 4 社の事例研究
USP 最新通知事項 2018年4月
USP 通知事項 2018 年 4 1 新しい標準品の情報です Catalog # Description 容量ロット 1098570 Celecoxib Related Compound D 25 mg F083E0 1133558 Choline Fenofibrate 50 mg F088G0 1175784 Desvenlafaxine Related Compound A 25 mg F076C0
USP 最新通知事項 2018年5月.xlsx
USP 通知事項 2018 年 5 1 新しい標準品の情報です Catalog # Description 容量ロット 1012288 Carotenes 3 x 100 mg F059U0 1046213 Azelastine Related Compound F 20 mg F077B0 1175784 Desvenlafaxine Related Compound A 25 mg F076C0
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Vol.3 No.7 2005/04/14 2005 4 7 MHRA FDA Health Canada EMEA [ Bextra ] valdecoxib 2005 [ Avonex ] interferon beta-1a FDA.2 2005 [ Xigris ] drotrecogin alfa FDA.3 2005 [ Trecator ] ethionamide USP FDA.4
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医薬品安全性情報 Vol.1 No.17(2003. 8. 1) 国立医薬品食品衛生研究所安全情報部 目次各国規制機関情報 製品承認情報- 服薬ガイド [ Roferon-A ](interferonα -2a) 米 FDA p.1 FDA/CDER による安全性に関する表示変更の概要 (2003 年 2 月 ) 米 FDA p.2 [ Topamax ](topiramate) 投与患者における乏汗症
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Brown Alpert Medical School 6, M4 :Brown Alpert Medical School :Memorial Hospital of Rhode Island :2016/09/22 2016/10/ :2016/09/26 2016/10/21 :Internal Medicine / Family Medicine : / Dr. John Miscovsky
政策研ニュースNo27
Views and Actions Points of View IMS World Review IMS Health Pfizer Johnson & Johnson Merck & Co Abbott Eli Lilly Amgen Wyeth Bristol Myers Squibb Schering Plough ForestBaxterMylanGlaxoSmithKline Novartis
第１章 製薬産業を取り巻く環境変化
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国立医薬品食品衛生研究所安全情報部目次各国規制機関情報 重要な警告 :[ Herceptin ](trastuzumab) 米 FDA...2 FDA/CDER による安全性に関する表示改訂の概要 (2005 年 7 月 ) 米 FDA...4 [ Adderall XR ](amphetamine 塩類 ) と重篤な有害事象 カナダ Health Canada...6 Thioridazine の販売停止
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Vol.1 o.27 (2003. 10. 10) [ Reductil ] sibutramine MRA.1 [ Celance ] pergolide MRA.2 SAIDs MRA.3 MRA.3 [ Prandin ] repaglinide FDA.4 FD&C Blue o.1 FDA.5 [BDDrFVIII] [ ReFacto ] moroctocog- ealth Canada.6
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第 32 回日本臨床薬理学会年会新規うつ病治療薬の開発状況 2011 年 12 月 3 日独立行政法人医薬品医療機器総合機構新薬審査第三部中林哲夫 はじめに 既に本学会利益相反委員会に申告しましたように 本演題発表に関連して 開示すべき COI 関係にある企業等はありません これまでの臨床と PMDA( 医薬品医療機器総合機構 ) での新薬の承認審査関係の業務関わった経験に基づき 個人の考えとして発表するものです
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第１部 一般的コメント
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はじめに 本演題発表に関連して 開示すべき COI 関係にある企業等はありません これまでの臨床と PMDA( 医薬品医療機器総合機構 ) での新薬の承認審査関係の業務関わった経験に基づき 個人の考えとして発表するものです 公開情報をもとに説明しますが 職務上の守秘義務により ご説明出来ない事もあり
第 22 回日本臨床精神神経薬理学会 第 42 回日本神経精神薬理学会合同年会シンポジウム 12 これからの臨床試験のスタイル 精神神経疾患領域における臨床試験の動向と課題 2012 年 10 月 20 日独立行政法人医薬品医療機器総合機構新薬審査第三部大阪大学臨床医工学融合研究教育センター招へい教授中林哲夫 はじめに 本演題発表に関連して 開示すべき COI 関係にある企業等はありません これまでの臨床と
第１章 国民年金における無年金
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国立医薬品食品衛生研究所安全情報部目次 http://www.nihs.go.jp/dig/sireport/index.html 各国規制機関情報 英 MHRA(Medicines and Healthcare products Regulatory Agency) Abacavir,didanosine: 心臓発作のリスク評価にはさらに多くのデータが必要と結論...2 Enoxaparin sodium[
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国立医薬品食品衛生研究所安全情報部目次 http://www.nihs.go.jp/dig/sireport/index.html I. 各国規制機関情報 英 MHRA(Medicines and Healthcare products Regulatory Agency) Tiotropium: [ Spiriva Respimat ] の安全性試験... 2 米 FDA(U. S. Food and
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