2009 6 28 () 8 7 5 III 9 18 16 14 12 10 8 6 4 2 0 12 6 () 3 4 5 6 11 5 () 2 2 1 1 1 1 1 1 1
1 8 4 ( 6) 2 Servier Valdoxan/Thymanax(agomelatine) Otsuka Samska(tolvaptan)me-too ( 5) 2 Cephalon armodafinil(nuvigil) Trion Pharma Removabtriomab-1(catumaxomab)( 3) 2 ( 2) 1 1 5(>100 ) 3 Servier Valdoxan/Thymanax(agomelatine)Otsuka Samska(tolvaptan) HanAll Cozaar XQ/Amosartan()GlaxoSmithKline lamictal ODT 4( 50100 ) 3( 2050 ) 2( 520 ) 1 2 1 2009 6 / () agomelatine Thymana x/valdoxa n Servier -1-2 5- () tolvaptan Samska Otsuka -2 () 2
/ () armodafinil Me-too Nuvigil Cephalon Alpha ( ) catumaxoma b Me-too Removabt riomab-1 Trion Pharma CD3 ( ) + amlodipine+l osartan / Amosarta n Cozaar XQ HanAll Pharmac eutical II 1 () lamotrigine / lamictal ODT GlaxoSmi thkline Lennox- Gastaut () mu tapentadol, IR Nucynta IR Gruenent hal () fumarate Fumader m Biogen Idec () 2 7 1 ( 6) 1 Novartis Muckle-Wells Ilaris(canakinumab) 1 ( 2)( 3) 5(>100 3
) 1 Novartis Muckle-Wells Ilaris(canakinumab) 4( 50100 ) 2 Xanodyne Zipsor Cumberland Amelior/Caldolor 23( 2050 ) 2 2009 6 / () Muckle-W canakinu mab Ilaris Novarti s ells 1b ( ) diclofenac potassium / Zipsor Xanody ne 1 2 ( ) lamotrigin e / Lamictal XR GlaxoS mithkli ne ( ) ibuprofen / Amelior Caldolor Cumber land Pharma ceutical s 1 2 ( ) taltirelin hydrate ODT / Ceredist OD Tablets 5 Mitsubi shi Tanabe Pharma () tocofersol an Vedrop Recorda ti E E ( ) ferumoxyt ol Feraheme AMAG Pharma ceutical s () 4
3 5 3 ( 6) 1 Theratechnologies tesamorelin acetate( 3) POZEN Vimovo(+) 5(>100 )Abbott Certriad() 4 ( 50100 ) 2( 520 ) 9 6 ( 6) 1 me-too ( 5) 2 ( 4) 1 ( 3) 1 3 50100 ( 4) 3 50100 ( 3) 1 2( 520 ) 2 1( 05 ) 2 1 3 2009 6 / () tesamorelin acetate Theratechn ologies ( ) / Fenofibrate+ rosuvastatin- 2 Abbott HMGCoA () 5
/ alpha-1 / antitrypsin, iv, Kamada Kamada / pramipexole- Boehringer ER Ingelheim Naproxen+ / esomeprazol e, POZEN POZEN Amicus migalastat Therapeutic hydrochloride s azilsartan Takeda Me-too fimasartan Boryung Me-too Zydus ZYH-1 Cadila apatinib Advenchen travoprost Alcon Avid florbetapir Radiophar maceuticals Serenity SER-120 Pharmaceu ticals diclofenac Fidia sodium α1 D3 H+ K+ ATP Alpha-galactosida () α-1 ( ) ( ) ( ) se stimulant Fabry ( ) II 1 ( II ) II ( ) alphagamma () VEGFR-2 RET ( ) (VEGF) F2 alpha FP () () () 1 2 ( ) 6
1 59 24 ( 19 ) 33 ( 30 ) 2 19 13 () 4 2009 6 SFDA 7
33 (30 ) 5 2009 6 SFDA 8
2 6 2009 6 SFDA 2 82 ( 49 ) 7 2009 6 SFDA The United Laboratories Ltd. AstraZeneca Pharmaceuticals LP 9
Pharmazeutische Fabrik Evers Mobic GmbH & Co.KG Difene Hanmi Pharmaceutical Co.,Ltd. Ventolin AstraZeneca AB Weidar Chem. & Pharm. Co., Ltd. Zyvox SANOFI INDUSTRIE WINTHROP Uni-Amocin Hanmi Pharm. Co.,Ltd. Novo Tazocin / Nordisk A/S Schering GmbH & Co. Produktions KG Wyeth Piperacillin Div. of Wyeth Targocid Holdings Corporation IMOVAX Gruppo Lepetit S.r.l. POLIO Arimidex Aventis Pharma Dagenham Aromasin Sanofi-Synthelabo VietNam Leunase Hanlim Pharmaceutical Co., Ltd. Sanofi-Aventis Deutschland GmbH TAXOTERE R.P. Scherer GmbH & Co.KG Taxol Sandimmun SANOFI Neoral PASTEUR S.A. Thymoglobuline GLAXO WELLCOME,S.A. Levemir Sanofi-Aventis S.p.A. LANTUS Pfizer Pharmaceuticals LLC LANTUS 10
Humatrope Hanmi Fine Chemical Co.,Ltd. / Glaxo Wellcome S.A. Istituto De Angeli S.R.L. Spinax Schering GmbH & Co. Produktions KG Propess Temmler Werke GmbH -35 Diane-35 Hospira Australia Pty Ltd Mirena Genzyme Polyclonals S.A.S. CESRA Triquilar ARZNEIMITTEL GMBH () CO. KG Fresenius Kabi Deutschland Androcur GmbH Novartis Pharma AG Pfizer Italia S.r.l DAGES Kyowa Hakko Kogyo Co.,Ltd. Fuji Plant Lacipil Bristol Myers Squibb SRL Tritace Eli Lilly and Company Microcellulose Weissenborn GmbH + Co.KG (Subsidiary of J. Clexane Rettenmaier & Sohne GmbH + Co.KG) Lactacyd FH DSM Nutritional Products, Inc. Mallinckrodt Inc. biomerieux bv 11
A International Medication Systems, LTD (TP) Fresubin / (C8-24Ve) Lipofundin MCT/LCT Sasol Germany GmbH (15) (2) Glamin Mallinckrodt Inc. () 350 Optiray Fresenius Kabi Austria GmbH 320 Optiray DELPHARM LILLE SAS Controlled Therapeutics (Scotland) Limited Fluorescite Bayer Schering Pharma Oy 3 115 62 53 53 43 4 6 3 3 8 2009 6 3 3 1.1 1.1 2 3.1 3.1 3.1 12
3.1 3.1 3.1 3.1 3.1 3.1 3.1 3.1 3.1 3.2 3.2 3.3 62 52 6 4 3 3 9 2009 6 3 3 1 1 1 1.1 1.1 1.1 1.1 1.2 2 3.1 13
3.1 3.1 3.1 3.1 3.1 3.1 3.1 3.1 3.1 3.2 3.2 3.2 3.2 3.2 3.2 3.2 3.3 3.3 3.4 4 46 35 11 11 ( 8 ) 14
10 2009 6 35 (25 ) 30 4 1 11 2009 6 BI 1356 NIM811 () Pazopanib Tablets (GW786034B) 15
VIII SCV-07 16