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附件1化学仿制药参比制剂目录(第二十六批)(征求意见稿)序号药品通用名称英文名称/商品名规格剂型持证商备注1备注2丙酸氟替卡松乳膏Fluticasone Propionate Cream/Cutivate0.05%(15、30、50、100g)乳膏剂Glaxo Wellcome/Glaxosmithkline未进口原研药品欧盟上市枸橼酸芬太尼注射液Fentanyl Citrate Injection0.1mg(以芬太尼计)(2ml)注射剂ヤンセンファーマ株式会社未进口原研药品日本上市枸橼酸芬太尼注射液Fentanyl Citrate Injection0.25mg(以芬太尼计)(5ml)注射剂ヤンセンファーマ株式会社未进口原研药品日本上市枸橼酸芬太尼注射液Fentanyl Citrate Injection0.5mg(以芬太尼计)(10ml)注射剂ヤンセンファーマ株式会社未进口原研药品日本上市枸橼酸芬太尼注射液Fentanyl Citrate Injection/Sublimaze Preservative FreeEq 0.05mg Base/ml(2、5、10、20ml)注射剂Akorn Inc未进口原研药品美国橙皮书匹可硫酸钠口服溶液Sodium Picosulfate Oral Solution/Dulcolax5mg/5ml(以匹可硫酸钠计)(30、40、50、60、100、250、300ml)口服溶液剂Sanofi/Sanofi-Aventis/Aventis Pharma未进口原研药品欧盟上市乳酸喷他佐辛注射液Pentazocine Lactate Injection/Talwin30mg/ml(以喷他佐辛计)(1ml)注射剂Pfizer Canada未进口原研药品加拿大上市色甘酸钠滴眼液Sodium Cromoglicate Eye Drops/Opticrom; Lomudal;Alleoptical2%或20mg/ml(以色甘酸钠计)(5、10、13.5、0.3、0.35ml)滴眼剂Sanofi/Sanofi-Aventis未进口原研药品欧盟上市色甘酸钠滴眼液Sodium Cromoglicate Eye Drops/Lomudal40mg/ml(以色甘酸钠计)(0.35ml)滴眼剂Sanofi未进口原研药品欧盟上市色甘酸钠滴眼液Sodium Cromoglicate Eye Drops/Intal2%(以色甘酸钠计)(5ml)滴眼剂サノフィ株式会社未进口原研药品日本上市色甘酸钠滴眼液Sodium Cromoglicate Eye Drops/Intal UD2%(以色甘酸钠计)(0.35ml)滴眼剂サノフィ株式会社未进口原研药品日本上市氨甲环酸注射液Tranexamic Acid Injection/Transamin5%(250mg/5ml)注射剂第一三共株式会社未进口原研药品日本上市氨甲环酸注射液Tranexamic Acid Injection/Transamin10%(250mg/2.5ml、1g/10ml)注射剂第一三共株式会社未进口原研药品日本上市氨甲环酸注射液Tranexamic Acid Injection/Cyklokapron100mg/ml(5ml)注射剂Pfizer Corporation Austriages.M.B.H.未进口原研药品欧盟上市氨甲环酸注射液Tranexamic Acid Injection/Cyklokapron100mg/ml(10ml)注射剂Pharmacia and Upjohn Co未进口原研药品美国橙皮书司替戊醇干混悬剂Stiripentol Powder for Oral Suspension/Diacomit250mg干混悬剂Biocodex未进口原研药品欧盟上市司替戊醇干混悬剂Stiripentol Powder for Oral Suspension/Diacomit500mg干混悬剂Biocodex未进口原研药品欧盟上市维A酸乳膏Tretinoin Cream/Retin-A0.05%(20、45g)乳膏剂Valeant International Bermuda未进口原研药品美国橙皮书依折麦布瑞舒伐他汀钙片Ezetimibe and Rosuvastatin Calcium Tablets/Rosuzet依折麦布10mg/瑞舒伐他汀5mg片剂MSD株式会社未进口原研药品日本上市乙酰唑胺缓释胶囊Acetazolamide Extended-release Capsules500mg胶囊剂(缓释胶囊)Heritage Pharmaceuticals Inc国际公认的同种药品美国橙皮书阿加曲班注射液Argatroban Injection50mg/50ml(1mg/ml)注射剂Hikma Pharm Co Ltd未进口原研药品美国橙皮书阿加曲班氯化钠注射液Argatroban in Sodium Chloride Injection50mg/50ml(1mg/ml)注射剂Eagle Pharmaceuticals Inc未进口原研药品美国橙皮书酮咯酸氨丁三醇片Ketorolac Trometamol Tablets/Lixidol10mg片剂Atnahs Pharma Netherlands Bv未进口原研药品欧盟上市注射用甲磺酸齐拉西酮Ziprasidone Mesylate for Injection每瓶含30mg(以齐拉西酮计),441mg(磺丁基倍他环糊精钠)。临床应用时为20mg/ml(以齐拉西酮计)注射剂Pfizer Inc国内上市的原研药品原研进口丙戊酸钠注射液Sodium Valproate Injection/Ergenyl100mg/ml(以丙戊酸钠计)(4ml)注射剂Sanofi-Aventis Deutschland GmbH欧盟上市胞磷胆碱注射液Citicoline Injection/Nicholin2ml:250mg(以胞磷胆碱计)注射剂武田テバ薬品株式会社未进口原研药品日本上市胞磷胆碱注射液Citicoline Injection/Nicholin2ml:100mg(以胞磷胆碱计)注射剂武田テバ薬品株式会社未进口原研药品日本上市胞磷胆碱注射液Citicoline Injection/Nicholin10ml:500mg(以胞磷胆碱计)注射剂武田テバ薬品株式会社未进口原研药品日本上市胞磷胆碱注射液Citicoline Injection/Nicholin -H2ml:0.5g(以胞磷胆碱计)注射剂武田テバ薬品株式会社未进口原研药品日本上市胞磷胆碱注射液Citicoline Injection/Nicholin -H4ml:1g(以胞磷胆碱计)注射剂武田テバ薬品株式会社未进口原研药品日本上市胞磷胆碱钠注射液Citicoline Sodium Injection/Somazina4ml:1g(以胞磷胆碱计)注射剂Ferrer Internacional S.A.未进口原研药品欧盟上市胞磷胆碱钠注射液Citicoline Sodium Injection/Somazina4ml:500mg(以胞磷胆碱计)注射剂Ferrer Internacional S.A.未进口原研药品欧盟上市厄贝沙坦氨氯地平片Irbesartan and Amlodipine Tablets/Aimix厄贝沙坦100mg/氨氯地平5mg片剂大日本住友製薬株式会社未进口原研药品日本橙皮书厄贝沙坦氨氯地平片Irbesartan and Amlodipine Tablets/Aimix厄贝沙坦100mg/氨氯地平10mg片剂大日本住友製薬株式会社未进口原研药品日本橙皮书阿齐沙坦氨氯地平片Azilsartan and Amlodipine Tablets/Zacras阿齐沙坦20mg/氨氯地平2.5mg片剂武田薬品工業株式会社未进口原研药品日本橙皮书阿齐沙坦氨氯地平片Azilsartan and Amlodipine Tablets/Zacras阿齐沙坦20mg/氨氯地平5mg片剂武田薬品工業株式会社未进口原研药品日本橙皮书盐酸阿考替胺片Acotiamide Hydrochloride Tablets/Acofide100mg(以盐酸阿考替胺计)片剂ゼリア新薬工業株式会社/アステラス製薬株式会社未进口原研药品日本橙皮书盐酸异丙嗪注射液Promethazine Hydrochloride Injection/Phenergan25mg/ml(以盐酸异丙嗪计)(1、2ml)注射剂Aventis Pharma Limited未进口原研药品欧盟上市脂溶性维生素注射液(Ⅰ)Fat-Soluble Vitamin Injection(Ⅰ)/Vitalipide Enfants1ml:维生素A 69μg、维生素D2 1.0μg、维生素E 640μg、维生素K1 20μg。(10ml)注射剂Fresenius Kabi未进口原研药品欧盟上市脂溶性维生素注射液(Ⅱ)Fat-Soluble Vitamin Injection(Ⅱ)/Vitalipid Adult; Vitalipide Adultes1ml:维生素A 99μg、维生素D2 0.5μg、维生素E 910μg、维生素K1 15μg。(10ml)注射剂Fresenius Kabi未进口原研药品欧盟上市注射用高纯度尿促性素Highly Purified Menotrophin for Injection/Menopur(贺美奇)75IU FSH+75IU LH注射剂Ferring GmbH国内上市的原研药品原研进口注射用吲哚菁绿Indocyaninegreen for Injection/Ic-Green25mg注射剂Akorn Inc未进口原研药品美国橙皮书盐酸昂丹司琼注射液Ondansetron Hydrochloride Injection/Zophren; Zofran2mg/ml或4mg(以昂丹司琼计)(2ml)注射剂Novartis未进口原研药品欧盟上市盐酸昂丹司琼注射液Ondansetron Hydrochloride Injection/Zophren; Zofran2mg/ml或8mg(以昂丹司琼计)(4ml)注射剂Novartis未进口原研药品欧盟上市吲哚美辛凝胶贴膏剂Indometacin Cataplasm/Catlep每贴(14cm×10cm)含膏体14g,含吲哚美辛70mg贴膏剂帝國製薬株式会社未进口原研药品日本上市阿奇霉素滴眼液Azithromycin Ophthalmic Solution/Azasite1%(以阿奇霉素计)(2.5ml)眼用制剂Oka Pharmaceuticals Inc Subsidary Of Akorn Inc未进口原研药品美国橙皮书阿奇霉素滴眼液Azithromycin Eye Drops/Azyter15mg/G(以阿奇霉素二水合物计)(0.25g)眼用制剂Laboratoires Thea未进口原研药品欧盟上市倍他米松磷酸钠注射液Betamethasone Sodium Phosphate Injection/Rinderon0.4%(2mg:0.5ml)(以倍他米松计)注射剂塩野義製薬株式会社未进口原研药品日本上市倍他米松磷酸钠注射液Betamethasone Sodium Phosphate Injection/Rinderon0.4%(4mg:1ml)(以倍他米松计)注射剂塩野義製薬株式会社未进口原研药品日本上市倍他米松磷酸钠注射液Betamethasone Sodium Phosphate Injection/Rinderon0.4%(20mg:5ml)(以倍他米松计)注射剂塩野義製薬株式会社未进口原研药品日本上市奥氮平片Olanzapine Tablets/Zyprexa5mg片剂Eli Lilly and Co未进口原研药品美国橙皮书奥氮平片Olanzapine Tablets/Zyprexa5mg片剂日本イーライリリー株式会社未进口原研药品日本橙皮书奥氮平片Olanzapine Tablets/Zyprexa5mg片剂Eli Lilly Nederland B.V.未进口原研药品欧盟上市奥氮平片Olanzapine Tablets/Zyprexa10mg片剂Eli Lilly and Co未进口原研药品美国橙皮书奥氮平片Olanzapine Tablets/Zyprexa10mg片剂日本イーライリリー株式会社未进口原研药品日本橙皮书奥氮平片Olanzapine Tablets/Zyprexa10mg片剂Eli Lilly Nederland B.V.未进口原研药品欧盟上市奥氮平口崩片Olanzapine Orally Disintegrating Tablets/Zyprexa2.5mg片剂(口崩片)日本イーライリリー株式会社未进口原研药品日本橙皮书奥氮平口崩片Olanzapine Orally Disintegrating Tablets/Zyprexa Zydis5mg片剂(口崩片)Eli Lilly and Co未进口原研药品美国橙皮书奥氮平口崩片Olanzapine Orally Disintegrating Tablets/Zyprexa5mg片剂(口崩片)日本イーライリリー株式会社未进口原研药品日本橙皮书奥氮平口崩片Olanzapine Orodispersible Tablets/Zyprexa Velotab5mg片剂(口崩片)Eli Lilly Nederland B.V.未进口原研药品欧盟上市奥氮平口崩片Olanzapine Orally Disintegrating Tablets/Zyprexa Zydis10mg片剂(口崩片)Eli Lilly and Co未进口原研药品美国橙皮书奥氮平口崩片Olanzapine Orally Disintegrating Tablets/Zyprexa10mg片剂(口崩片)日本イーライリリー株式会社未进口原研药品日本橙皮书奥氮平口崩片Olanzapine Orodispersible Tablets/Zyprexa Velotab10mg片剂(口崩片)Eli Lilly Nederland B.V.未进口原研药品欧盟上市奥氮平口崩片Olanzapine Orally Disintegrating Tablets/Zyprexa Zydis15mg片剂(口崩片)Eli Lilly and Co未进口原研药品美国橙皮书奥氮平口崩片Olanzapine Orodispersible Tablets/Zyprexa Velotab15mg片剂(口崩片)Eli Lilly Nederland B.V.未进口原研药品欧盟上市奥氮平口崩片Olanzapine Orally Disintegrating Tablets/Zyprexa Zydis20mg片剂(口崩片)Eli Lilly and Co未进口原研药品美国橙皮书奥氮平口崩片Olanzapine Orodispersible Tablets/Zyprexa Velotab20mg片剂(口崩片)Eli Lilly Nederland B.V.未进口原研药品欧盟上市阿哌沙班片Apixaban Tablets/Eliquis2.5mg片剂Bristol-Myers Squibb Co Pharmaceutical Research Institude未进口原研药品美国橙皮书阿奇霉素细粒剂Azithromycin Fine Granules for Pediatric Use 10%/Zithromac10%(以阿奇霉素计)(1g/包、100g/瓶)细粒剂ファイザー株式会社(辉瑞)未进口原研药品日本橙皮书精氨酸布洛芬颗粒Arginine and Ibuprofen Granules/Spedifen; Spididol200mg(以布洛芬计)颗粒剂Zambon未进口原研药品欧盟上市精氨酸布洛芬颗粒Arginine and Ibuprofen Granules/Spedifen; Spididol400mg(以布洛芬计)颗粒剂Zambon未进口原研药品欧盟上市精氨酸布洛芬颗粒Arginine and Ibuprofen Granules/Spedifen; Spididol600mg(以布洛芬计)颗粒剂Zambon未进口原研药品欧盟上市注射用醋酸西曲瑞克Cetrorelix Acetate for Injection/Cetrotide(思则凯)0.25mg(以西曲瑞克计)注射剂Merck Europe B.V.国内上市的原研药品原研进口注射用醋酸西曲瑞克Cetrorelix Acetate for Injection/Cetrotide0.25mg(以西曲瑞克计)注射剂Emd Serono Inc未进口原研药品美国橙皮书阿达帕林过氧苯甲酰凝胶Adapalene and Benzoyl Peroxide Gel/Epiduo forte0.3%;2.5%(15、30、45、60、70gram Pump)凝胶剂Galderma Laboratories.未进口原研药品美国橙皮书氨溴特罗口服溶液Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution/Spasmo-Mucosolvan Saft1ml:盐酸氨溴索1.5mg与盐酸克仑特罗1μg(100、250、1000ml)口服溶液剂Sanofi-Aventis Deutschland GmbH.未进口原研药品欧盟上市酮康唑洗剂Ketoconazole Shampoo/Nizoral A-D1%(125、200ml)洗剂Kramer Laboratories Inc.未进口原研药品美国橙皮书富马酸酮替芬口服溶液Ketotifen Fumarate Oral Solution/Zaditen0.02%(以酮替芬计)(500ml)糖浆剂サンファーマ株式会社未进口原研药品日本上市富马酸酮替芬口服溶液Ketotifen Fumarate Oral Solution/Zaditen1mg/5ml(以酮替芬计)(100、150、200、300ml)口服溶液/糖浆剂Alfasigma S.P.A.未进口原研药品欧盟上市注射用头孢孟多酯钠Cefamandole Nafate for Injection/Mandol1.0g(以头孢孟多计)注射剂Eurocept Bv未进口原研药品欧盟上市注射用头孢孟多酯钠Cefamandole Nafate for Injection/Mandol2.0g(以头孢孟多计)注射剂Eurocept Bv未进口原研药品欧盟上市去氧孕烯炔雌醇片Desogestrel and Ethinylestradiol Tablets/-每片含去氧孕烯0.15mg和炔雌醇20μg片剂N.anon国内上市的原研药品原研进口去氧孕烯炔雌醇片Desogestrel and Ethinylestradiol Tablets/Mercilon每片含去氧孕烯0.15mg和炔雌醇20μg片剂N.anon/MSD未进口原研药品欧盟上市盐酸利多卡因注射液Lidocaine Hydrochloride Injection/Xylocaine; Xylocain1%或10mg/ml(以盐酸利多卡因计)(5、10、20ml)注射剂Aspen未进口原研药品欧盟上市盐酸利多卡因注射液Lidocaine Hydrochloride Injection/Xylocaine Injection Polyamp1%(以盐酸利多卡因计)(5、10ml)注射剂アスペンジャパン株式会社未进口原研药品日本上市盐酸利多卡因注射液Lidocaine Hydrochloride Injection/Xylocaine2%(以盐酸利多卡因计)(2、5、10ml)注射剂Fresenius Kabi USA LLC未进口原研药品美国橙皮书盐酸利多卡因注射液Lidocaine Hydrochloride Injection/Xylocaine2%(以盐酸利多卡因计)(5、10ml)注射剂アスペンジャパン株式会社未进口原研药品日本上市盐酸利多卡因注射液Lidocaine Hydrochloride Injection/Xylocaine0.5%(以盐酸利多卡因计)(50ml)注射剂Fresenius Kabi USA LLC未进口原研药品美国橙皮书盐酸利多卡因注射液Lidocaine Hydrochloride Injection/Xylocaine Injection Polyamp0.5%(以盐酸利多卡因计)(5、10ml)注射剂アスペンジャパン株式会社未进口原研药品日本上市盐酸利多卡因注射液Lidocaine Hydrochloride Injection/Xylocaine0.5%或5mg/ml(以盐酸利多卡因计)(10、20ml)注射剂Aspen未进口原研药品欧盟上市盐酸利多卡因注射液Lidocaine Hydrochloride Injection/Xylocaine1.5%(以盐酸利多卡因计)(50ml)注射剂Fresenius Kabi USA LLC未进口原研药品美国橙皮书盐酸鲁拉西酮片Lurasidone Hydrochloride Tablets/Latuda40mg(以盐酸鲁拉西酮计)片剂Sunovion Pharmaceuticals Inc未进口原研药品美国橙皮书盐酸帕洛诺司琼注射液Palonosetron Hydrochloride Injection/Aloxi0.25mg/5ml(0.05mg/ml)注射剂Helsinn Healthcare SA未进口原研药品美国橙皮书盐酸帕洛诺司琼注射液Palonosetron Hydrochloride Injection/Aloxi250μg/5ml(以帕洛诺司琼计)注射剂Helsinn Birex Pharmaceuticals Ltd.未进口原研药品欧盟上市盐酸帕洛诺司琼注射液Palonosetron Hydrochloride Injection/Aloxi5ml:0.25mg(以帕洛诺司琼计算)注射剂Lee’s Pharmaceutical(HK)Ltd国内上市的原研药品原研进口盐酸帕洛诺司琼注射液Palonosetron Hydrochloride Injection/Aloxi0.075mg/1.5ml(以帕洛诺司琼计)注射剂Lee’s Pharmaceutical(HK)Ltd国内上市的原研药品原研进口熊去氧胆酸颗粒Ursodeoxycholic Acid Granules/Urso5%,1g颗粒剂田辺三菱製薬株式会社未进口原研药品日本橙皮书西咪替丁注射液Cimetidine Injection/Tagamet2ml:0.2g注射剂大日本住友製薬株式会社未进口原研药品日本上市盐酸氨溴索滴剂Ambroxol Hydrochloride Drops/Mucosolvan30mg/2ml(50ml、100ml)滴剂Sanofi-Aventis Deutschland GmbH未进口原研药品欧盟上市盐酸非索非那定口服混悬液Fexofenadine Hydrochloride Oral Suspension/Children's Allegra Allergy30mg/5ml口服混悬剂Sanofi AventisUS LLC未进口原研药品美国橙皮书奥扎格雷钠注射液Ozagrel Sodium Injection/Cataclot,Xanbon20mg/2.5ml注射剂丸石製薬株式会社/キッセイ薬品工業株式会社未进口原研药品日本上市奥扎格雷钠注射液Ozagrel Sodium Injection/Cataclot,Xanbon40mg/5ml注射剂丸石製薬株式会社/キッセイ薬品工業株式会社未进口原研药品日本上市注射用盐酸万古霉素Vancomycin Hydrochloride for Injection/Vancocin(稳可信)500mg注射剂Eli Lilly Italia S.P.A.国内上市的原研药品原研进口注射用乌司他丁Ulinastatin for Injection/Miraclid2.5万单位注射剂持田製薬株式会社未进口原研药品日本上市注射用乌司他丁Ulinastatin for Injection/Miraclid5万单位注射剂持田製薬株式会社未进口原研药品日本上市注射用乌司他丁Ulinastatin for Injection/Miraclid10万单位注射剂持田製薬株式会社未进口原研药品日本上市琥珀酸多西拉敏片Doxylamine Succinate Tablets/Unisom25mg片剂Chattem Inc未进口原研药品美国橙皮书聚维酮碘滴眼液Povidone-Iodine Ophthalmic Solution/Betadine5%(30ml)眼用制剂Alcon Pharmaceuticals Ltd未进口原研药品美国橙皮书富马酸喹硫平缓释片Quetiapine Fumarate Extended-release Tablets/Seroquel Xr150mg片剂(缓释片)Astrazeneca Uk Ltd/Astrazeneca Pharmaceuticals Lp未进口原研药品美国橙皮书富马酸喹硫平缓释片Quetiapine Fumarate Extended-release Tablets/Seroquel Xr50mg片剂(缓释片)Astrazeneca Uk Ltd/Astrazeneca Pharmaceuticals Lp未进口原研药品美国橙皮书富马酸喹硫平缓释片Quetiapine Fumarate Extended-release Tablets/Seroquel Xr200mg片剂(缓释片)Astrazeneca Uk Ltd/Astrazeneca Pharmaceuticals Lp未进口原研药品美国橙皮书富马酸喹硫平缓释片Quetiapine Fumarate Extended-release Tablets/Seroquel Xr300mg片剂(缓释片)Astrazeneca Uk Ltd/Astrazeneca Pharmaceuticals Lp未进口原研药品美国橙皮书富马酸喹硫平缓释片Quetiapine Fumarate Extended-release Tablets/Seroquel Xr400mg片剂(缓释片)Astrazeneca Uk Ltd/Astrazeneca Pharmaceuticals Lp未进口原研药品美国橙皮书硫辛酸片Thioctic Acid Tablets/Thioctacid0.2g片剂Meda Pharma GmbH & Co. Kg未进口原研药品欧盟上市羟考酮纳洛酮缓释片Oxycodone Hydrochlorideand Naloxone Hydrochloride Dehydrate Prolonged release Tablets/Targin5mg/2.5mg片剂(缓释片)Mundipharma Gmbh未进口原研药品欧盟上市羟考酮纳洛酮缓释片Oxycodone Hydrochlorideand Naloxone Hydrochloride Dehydrate Prolonged release Tablets/Targin10mg/5mg片剂(缓释片)Mundipharma Gmbh未进口原研药品欧盟上市羟考酮纳洛酮缓释片Oxycodone Hydrochlorideand Naloxone Hydrochloride Dehydrate Prolonged release Tablets/Targin20mg/10mg片剂(缓释片)Mundipharma Gmbh未进口原研药品欧盟上市羟考酮纳洛酮缓释片Oxycodone Hydrochlorideand Naloxone Hydrochloride Dehydrate Prolonged release Tablets/Targin40mg/20mg片剂(缓释片)Mundipharma Gmbh未进口原研药品欧盟上市依折麦布阿托伐他汀钙片Ezetimibe and AtorvastatinCalcium Trihydrate Tablets10mg/10mg片剂Merck Sharp & Dohme未进口原研药品欧盟上市依折麦布阿托伐他汀钙片Ezetimibe and AtorvastatinCalcium Trihydrate Tablets10mg/20mg片剂Merck Sharp & Dohme未进口原研药品欧盟上市二十碳五烯酸乙酯软胶囊Ethyl Iosapentate Capsules/Epadel300mg胶囊剂(软胶囊)Mochida Pharmaceutical Co., Ltd. 未进口原研药品日本橙皮书伏立康唑片Voriconazole Tablets/Vfend50mg片剂Pfizer Europe Ma EEIG未进口原研药品欧盟上市伏立康唑干混悬剂Voriconazole for Oral Suspension/Vfend200mg/5ml口服混悬剂(干混悬剂)Pf Prism CV未进口原研药品美国橙皮书伏格列波糖口崩片Voglibose Orally Dispersing Tablets/Basen0.2mg片剂(口崩片)Teva Takeda Yakuhin Ltd.未进口原研药品日本橙皮书恩扎卢胺软胶囊Enzalutamide Soft Capsules/Xtandi40mg胶囊剂Astellas Pharma Europe B.V.未进口原研药品欧盟上市克林霉素磷酸酯注射液Clindamycin Phosphate Injection/Dalacin S300mg/2ml注射剂ファイザー株式会社未进口原研药品日本上市丁丙诺啡透皮贴剂Buprenorphine Transdermal Patches/Norspan5μg/h贴剂Mundipharma A/S/Mundipharma GmbH未进口原研药品欧盟上市丁丙诺啡透皮贴剂Buprenorphine Transdermal Patches/Norspan10μg/h贴剂Mundipharma A/S/Mundipharma GmbH未进口原研药品欧盟上市丁丙诺啡透皮贴剂Buprenorphine Transdermal Patches/Norspan20μg/h贴剂Mundipharma A/S/Mundipharma GmbH未进口原研药品欧盟上市丁丙诺啡透皮贴剂Buprenorphine Transdermal Patches/Transtec35μg/h贴剂Gr?Nenthal GmbH/Gr?Nenthal GesmbH未进口原研药品欧盟上市丁丙诺啡透皮贴剂Buprenorphine Transdermal Patches/Transtec52.5μg/h贴剂Gr?Nenthal GmbH/Gr?Nenthal GesmbH未进口原研药品欧盟上市丁丙诺啡透皮贴剂Buprenorphine Transdermal Patches/Transtec70μg/h贴剂Gr?Nenthal GmbH/Gr?Nenthal GesmbH未进口原研药品欧盟上市克霉唑乳膏Clotrimazole Cream/Canesten10%(5g)乳膏剂Bayer plc未进口原研药品欧盟上市地西泮灌肠液Diazepam Rectal Solution/--5mg/2.5ml灌肠剂Desitin Arzneimittel GmbH未进口原研药品欧盟上市醋酸氟氢可的松片Fludrocortisone Acetate Tablets/Florinef0.1mg片剂アスペンジャパン株式会社/Aspen Japan K.K.未进口原研药品日本橙皮书加巴喷丁胶囊Gabapentin Capsules/Neurontin100mg胶囊剂Pfizer Pharmaceuticals Ltd未进口原研药品美国橙皮书加巴喷丁胶囊Gabapentin Capsules/Neurontin300mg胶囊剂Pfizer Pharmaceuticals Ltd未进口原研药品美国橙皮书加巴喷丁胶囊Gabapentin Capsules/Neurontin400mg胶囊剂Pfizer Pharmaceuticals Ltd未进口原研药品美国橙皮书酒石酸阿福特罗雾化吸入用溶液Arformoterol Tartrate Inhalation Solution/Brovana0.015mg/2ml吸入用溶液剂Sunovion Pharmaceuticals Inc未进口原研药品美国橙皮书拉考沙胺糖浆Lacosamide Syrup/Vimpat 10mg/ml Syrup10mg/ml(200ml/瓶)糖浆剂UCB Pharma S.A.未进口原研药品欧盟上市拉考沙胺干糖浆Lacosamide Dry Syrup/Vimpat Dry Syrup 10%10%(100g/瓶)干糖浆剂ユーシービージャパン株式会社(UCB株式会社)未进口原研药品日本橙皮书拉考沙胺干糖浆Lacosamide Dry Syrup/Vimpat Dry Syrup 10%10%(500g/瓶)干糖浆剂ユーシービージャパン株式会社(UCB株式会社)未进口原研药品日本橙皮书利奈唑胺干混悬剂Linezolid for Suspension/Zyvox100mg/5ml口服混悬剂(干混悬剂)Pharmacia and Upjohn Co未进口原研药品美国橙皮书硫酸鱼精蛋白注射液Protamine Sulfate Injection10mg/ml(5ml)注射剂Fresenius KabiUSA LLC国际公认的同种药品美国橙皮书腺苷注射液Adenosine Injection/Adenoscan Injection60mg(20ml)注射剂第一三共株式会社未进口原研药品日本上市注射用达托霉素Daptomycin for Injection/Cubicin500mg/Vial注射剂Cubist Pharmaceuticals, LLC/Merck & Co., Inc.未进口原研药品美国橙皮书钆喷酸葡胺注射液Gadopentetic Acid Dimeglumine Salt Injection/Magnevist(马根维显)469.01mg/ml(10ml)注射剂Bayer Inc.国内上市的原研药原研进口钆喷酸葡胺注射液Gadopentetic Acid Dimeglumine Salt Injection/Magnevist(马根维显)469.01mg/ml(15ml)注射剂Bayer Inc.国内上市的原研药原研进口钆喷酸葡胺注射液Gadopentetic Acid Dimeglumine Salt Injection/Magnevist(马根维显)469.01mg/ml(20ml)注射剂Bayer Inc.国内上市的原研药原研进口甲硝唑凝胶Metronidazolegel/Metrogel0.75%(45g)凝胶剂Galderma Laboratories Lp未进口原研药品美国橙皮书甲硝唑凝胶Metronidazolegel/Metrogel1%(60,55g)凝胶剂Galderma Laboratories Lp未进口原研药品美国橙皮书卡泊三醇倍他米松软膏Calcipotriol and Betamethasone Ointment1g:卡泊三醇50mg;倍他米松0.5mg软膏剂Leo Pharma A/S国内上市的原研药原研进口硫酸吗啡盐酸纳曲酮缓释胶囊Morphine Sulfate and Naltrexone Hydrochloride Extended-release Capsules/Embeda20mg;0.8mg胶囊剂(缓释胶囊)Alpharma Pharmaceuticals LLC未进口原研药品美国橙皮书硫酸吗啡盐酸纳曲酮缓释胶囊Morphine Sulfate and Naltrexone Hydrochloride Extended-release Capsules/Embeda30mg;1.2mg胶囊剂(缓释胶囊)Alpharma Pharmaceuticals LLC未进口原研药品美国橙皮书硫酸吗啡盐酸纳曲酮缓释胶囊Morphine Sulfate and Naltrexone Hydrochloride Extended-release Capsules/Embeda50mg;2mg胶囊剂(缓释胶囊)Alpharma Pharmaceuticals LLC未进口原研药品美国橙皮书硫酸吗啡盐酸纳曲酮缓释胶囊Morphine Sulfate and Naltrexone Hydrochloride Extended-release Capsules/Embeda60mg;2.4mg胶囊剂(缓释胶囊)Alpharma Pharmaceuticals LLC未进口原研药品美国橙皮书硫酸吗啡盐酸纳曲酮缓释胶囊Morphine Sulfate and Naltrexone Hydrochloride Extended-release Capsules/Embeda80mg;3.2mg胶囊剂(缓释胶囊)Alpharma Pharmaceuticals LLC未进口原研药品美国橙皮书硫酸吗啡盐酸纳曲酮缓释胶囊Morphine Sulfate and Naltrexone Hydrochloride Extended-release Capsules/Embeda100mg;4mg胶囊剂(缓释胶囊)Alpharma Pharmaceuticals LLC未进口原研药品美国橙皮书琥珀酸普芦卡必利片Prucalopride Succinate Tablets/Resolor1mg片剂Shire Pharmaceuticals Ireland Limited未进口原研药品欧盟上市链霉蛋白酶颗粒Pronase Granules/Promase Ms0.5g:20000单位颗粒剂科研製薬株式会社未进口原研药品日本橙皮书格隆溴铵注射液Glycopyrrolate Injection/Glycopyrrolate1ml:0.2mg注射剂Hikma Farmaceutica(Portugal)Sa国际公认的同种药品美国橙皮书格隆溴铵注射液Glycopyrrolate Injection/Glycopyrrolate2ml:0.4mg注射剂Hikma Farmaceutica(Portugal)Sa国际公认的同种药品美国橙皮书甲钴胺注射液Mecobalamin Injection/弥可保1ml:0.5mg注射剂卫材(中国)药业有限公司经审核确定的国外原研企业在中国境内生产的药品原研地产化盐酸氨溴索口服溶液Ambroxol Hydrochloride Oral Solution/Mucosolvan Kindersaft/ Mucosolvan Hustensaft100ml:0.6g(100ml)口服溶液剂Sanofi-Aventis Deutschland GmbH未进口原研药品欧盟上市维生素K1注射液(胶束注射液)Vitamin K1 Injection/Konakion MM 10mg1ml:10mg注射剂Cheplapharm Arzneimittel GmbH/Roche Pharma AG未进口原研药品欧盟上市维生素K1注射液Vitamin K1 Injection1ml:10mg注射剂Hospira Inc国际公认的同种药品美国橙皮书盐酸左西替利嗪口服滴剂Levocetirizine Dihydrochloride Oral Drops,Solution0.5%(10ml,15ml,20ml)口服溶液剂UCB Pharma S.P.A.未进口原研药品欧盟上市玻璃酸钠滴眼液Sodium Hyaluronate Eye Drops/Hialid(爱丽)5ml:5mg(分子量范围:50万~149万)眼用制剂参天制药(中国)有限公司经审核确定的国外原研企业在中国境内生产的药品原研地产化玻璃酸钠滴眼液Sodium Hyaluronate Eye Drops/Hialid(爱丽)5ml:15mg(分子量范围:50万~149万)眼用制剂参天制药(中国)有限公司经审核确定的国外原研企业在中国境内生产的药品原研地产化玻璃酸钠滴眼液Sodium Hyaluronate Eye Drops/Hycosan(海露)0.1%(10ml)(分子量范围:200万~300万)(无防腐剂)眼用制剂Eusan GmbH国内上市的原研药品原研进口布地奈德缓释片Budesonide Extended release Tablets/Uceris9mg片剂(缓释片)Salix Pharmaceuticals Inc未进口原研药品美国橙皮书帕拉米韦注射液Peramivir Injection/Rapiacta300mg(60ml)注射剂塩野義製薬株式会社未进口原研药品日本上市蛋白琥珀酸铁口服溶液Iron Proteinsuccinylate Oral Solution/Ferplex(菲普利)15ml:40mg(以铁计)口服溶液剂Italfarmaco S.A.国内上市的原研药品原研进口盐酸甲哌卡因注射液Mepivacaine Hydrochloride Injection/Scandonest(斯康杜尼)1.8ml:54mg注射剂Septodont国际公认的同种药品国际公认进口盐酸甲哌卡因/肾上腺素注射液Mepivacaine Hydrochloride and AdrenalineInjection/Scandonest(斯康杜尼)1.8ml/支注射剂Septodont国内上市的原研药品原研进口盐酸罗沙替丁醋酸酯缓释胶囊Roxatidine Acetate Hydrochloride Sustained Release Capsules/ALTAT75mg胶囊剂あすか製薬株式会社未进口原研日本上市盐酸西替利嗪滴眼液Cetirizine Ophthalmic Solution/Zerviate0.24%(5ml)滴眼剂Eyevance PharmaceuticalsLlc未进口原研药品美国橙皮书盐酸西替利嗪滴眼液Cetirizine Ophthalmic Solution/Zerviate0.24%(7.5ml)滴眼剂Eyevance PharmaceuticalsLlc未进口原研药品美国橙皮书注射用盐酸表柔比星Epirubicin Hydrochloride for Injection/Farmorubicin10mg注射剂ファイザー株式会社未进口原研药品日本上市盐酸格拉司琼注射液Granisetron Hydrochloride Injection/Kytril3mg/3ml注射剂Roche/Atnahs Pharma Netherlands B.V.未进口原研药品欧盟上市盐酸多巴胺注射液Dopamine Hydrochloride Injection/Inovan2.5ml:50mg注射剂協和発酵キリン株式会社未进口原研药品日本上市盐酸多巴胺注射液Dopamine Hydrochloride Injection/Inovan5ml:100mg注射剂協和発酵キリン株式会社未进口原研药品日本上市盐酸多巴胺注射液Dopamine Hydrochloride Injection/--5ml:200mg注射剂Hospira Uk Limited未进口原研药品欧盟上市泮托拉唑钠肠溶干混悬剂Pantoprazole Sodium for Suspension, Delayed Release/Protonix40mg口服混悬剂Wyeth Pharmaceuticals Inc未进口原研药品美国橙皮书帕立骨化醇胶囊Paricalcitol Capsule/Zemplar1mg胶囊剂Abbvie Inc.未进口原研药品美国橙皮书帕立骨化醇胶囊Paricalcitol Capsule/Zemplar2mg胶囊剂Abbvie Inc未进口原研药品美国橙皮书替格瑞洛分散片Ticagrelor Orodispersible Tablet/Brilique90mg片剂Astrazeneca AB未进口原研药品欧盟上市盐酸妥洛特罗片Chlobamolie Hydrochloride Tablets/Berachin1mg片剂ニプロESファーマ株式会社未进口原研药品日本橙皮书盐酸妥洛特罗片Chlobamolie Hydrochloride Tablets/Hokunalin1mg片剂マイランEPD合同会社未进口原研药品日本橙皮书妥洛特罗贴剂Tulobuterol Patch/Hokunalin0.5mg/贴贴剂マイランEPD合同会社未进口原研药品日本上市妥洛特罗贴剂Tulobuterol Patch/Hokunalin1mg/贴贴剂マイランEPD合同会社未进口原研药品日本上市妥洛特罗贴剂Tulobuterol Patch/Hokunalin2mg/贴贴剂マイランEPD合同会社未进口原研药品日本上市普瑞巴林缓释片Pregabalin Extended release Tablets/Lyrica Cr82.5mg片剂(缓释片)Pf Prism CV未进口原研药品美国橙皮书普瑞巴林缓释片Pregabalin Extended release Tablets/Lyrica Cr165mg片剂(缓释片)Pf Prism CV未进口原研药品美国橙皮书普瑞巴林缓释片Pregabalin Extended release Tablets/Lyrica Cr330mg片剂(缓释片)Pf Prism CV未进口原研药品美国橙皮书苏沃雷生片Suvorexant Tablets/Belsomra10mg片剂MSD株式会社未进口原研药品日本橙皮书苏沃雷生片Suvorexant Tablets/Belsomra15mg片剂MSD株式会社未进口原研药品日本橙皮书苏沃雷生片Suvorexant Tablets/Belsomra20mg片剂MSD株式会社未进口原研药品日本橙皮书盐酸布比卡因注射液Bupivacaine Hydrochloride Injection/Marcaine Hydrochloride Preservative Free0.5%(10ml:50mg)注射剂Hospira Inc未进口原研药品美国橙皮书盐酸布比卡因注射液Bupivacaine Hydrochloride Injection/Marcaine Hydrochloride Preservative Free0.75%(10ml:75mg)注射剂Hospira Inc未进口原研药品美国橙皮书依利格鲁司他胶囊Eliglustat Capsules/Cerdelga84mg胶囊剂Genzyme Europe B.V.未进口原研药品欧盟上市注射用乳糖酸红霉素Erythromycin Lactobionate for Injection/Erythrocin500mg/VIAL(普通西林瓶)注射剂Hospira Inc未进口原研药品美国橙皮书盐酸奥洛他定颗粒Olopatadine Hydrochloride Granules/Allelock0.5%(0.5g/袋)颗粒剂協和キリン株式会社未进口原研药品日本橙皮书盐酸溴己新细粒剂Bromhexine Hydrochloride Fine Granules/Bisolvon2%(100g/瓶)细粒剂サノフィ株式会社未进口原研药品日本橙皮书注射用尼可地尔Nicorandil for Injection/Sigmart2mg注射剂中外製薬株式会社未进口原研药品日本上市注射用尼可地尔Nicorandil for Injection/Sigmart12mg注射剂中外製薬株式会社未进口原研药品日本上市注射用尼可地尔Nicorandil for Injection/Sigmart48mg注射剂中外製薬株式会社未进口原研药品日本上市注射用哌拉西林钠Piperacillin Sodium for Injection/Pentcillin1g注射剂富士フイルム富山化学株式会社未进口原研药品日本上市注射用哌拉西林钠Piperacillin Sodium for Injection/Pentcillin2g注射剂富士フイルム富山化学株式会社未进口原研药品日本上市莫匹罗星软膏Mupirocin Ointment/Bactroban2%(15g/支)软膏剂Beecham/GlaxoSmithKline未进口原研药品欧盟上市欧米加-3-酸乙酯软胶囊Omega-3-Acid Ethyl Esters Soft Capsules/Lovaza1GM CONTAINS ATLEAST 900mg OFTHE ETHYL ESTERSOF OMEGA-3 FATTYACIDS胶囊剂(软胶囊)Smithkline Beecham/GlaxoSmithKline未进口原研药品美国橙皮书盐酸托莫西汀口服溶液Atomoxetine Hydrochloride Oral Solution100ml:400mg,4mg/ml(以C17H21NO计)口服溶液剂Eli Lilly & Company Limited国内上市的原研药品原研进口盐酸托莫西汀口服溶液Atomoxetine Hydrochloride Oral Solution/Strattera100ml:400mg,4mg/ml(以C17H21NO计)口服溶液剂Lilly未进口原研药品欧盟上市塞来昔布片Celecoxib Tablets/Celecox100mg片剂Astellas Pharma Inc.未进口原研药品日本橙皮书塞来昔布片Celecoxib Tablets/Celecox200mg片剂Astellas Pharma Inc.未进口原研药品日本橙皮书西格列汀二甲双胍缓释片Sitagliptin and Metformin Hydrochloride Extended-release Tablets/Janumet Xr以西格列汀/盐酸二甲双胍计50mg/500mg片剂(缓释片)Merck Sharp and Dohme Corp未进口原研药品美国橙皮书西格列汀二甲双胍缓释片Sitagliptin and Metformin Hydrochloride Extended-release Tablets/Janumet Xr以西格列汀/盐酸二甲双胍计50mg/1000mg片剂(缓释片)Merck Sharp and Dohme Corp未进口原研药品美国橙皮书西格列汀二甲双胍缓释片Sitagliptin and Metformin Hydrochloride Extended-release Tablets/Janumet Xr以西格列汀/盐酸二甲双胍计100mg/1000mg片剂(缓释片)Merck Sharp and Dohme Corp未进口原研药品美国橙皮书注射用头孢呋辛钠Cefuroxime Sodium for Injection/Zinacef以头孢呋辛(C16H16N4O8S)计250mg注射剂GlaxoSmithKline UK未进口原研药品欧盟上市(上市国英国)注射用头孢呋辛钠Cefuroxime Sodium for Injection/Zinacef以头孢呋辛(C16H16N4O8S)计1.5g注射剂GlaxoSmithKline UK未进口原研药品欧盟上市(上市国英国)硝呋太尔片Nifuratel Tablets/Macmiror(麦咪诺)200mg片剂Polichem S.R.L.国内上市的原研药品原研进口柳氮磺吡啶口服混悬液Sulfasalazine Oral Suspension250mg:5ml口服混悬剂Rosemont Pharmaceuticals Ltd欧盟上市盐酸普拉克索缓释片Pramipexole Dihydrochloride Extended release Tablets/Mirapex ER0.375mg片剂Boehringer Ingelheim Pharmaceuticals Inc未进口原研药品美国橙皮书盐酸普拉克索缓释片Pramipexole Dihydrochloride Extended release Tablets/Mirapex ER1.5mg片剂Boehringer Ingelheim Pharmaceuticals Inc未进口原研药品美国橙皮书盐酸普拉克索缓释片Pramipexole Dihydrochloride Prolonged-release Tablets/Sifrol0.26mg片剂Boehringer Ingelheim International GmbH未进口原研药品欧盟上市盐酸普拉克索缓释片Pramipexole Dihydrochloride Prolonged-release Tablets/Sifrol1.05mg片剂Boehringer Ingelheim International GmbH未进口原研药品欧盟上市盐酸普拉克索缓释片Pramipexole Dihydrochloride Prolonged-release Tablets/Sifrol2.1mg片剂Boehringer Ingelheim International GmbH未进口原研药品欧盟上市盐酸普拉克索缓释片Pramipexole Dihydrochloride Prolonged-release Tablets/Sifrol3.15mg片剂Boehringer Ingelheim International GmbH未进口原研药品欧盟上市盐酸美金刚片Memantine Hydrochloride Tablets/Namenda5mg片剂Allergan Sales LLC未进口原研药品美国橙皮书盐酸美金刚片Memantine Hydrochloride Tablets/Namenda10mg片剂Allergan Sales LLC未进口原研药品美国橙皮书盐酸美金刚口服溶液Memantine Hydrochloride Oral Solution/Axura每掀0.5ml,含盐酸美金刚5mg,50ml/瓶口服溶液剂Merz Pharmaceuticals GmbH未进口原研药品欧盟上市盐酸美金刚口服溶液Memantine Hydrochloride Oral Solution/Axura每掀0.5ml,含盐酸美金刚5mg,100ml/瓶口服溶液剂Merz Pharmaceuticals GmbH未进口原研药品欧盟上市盐酸美金刚口服溶液Memantine Hydrochloride Oral Solution/Memantine Hydrochloride2mg/ml(360ml)口服溶液剂Lannett Co Inc国际公认的同种药品美国橙皮书依折麦布片Ezetimibe Tablets/Zetia10mg片剂MSD International GmbH未进口原研药品美国橙皮书碘帕醇注射液Iopamidol Injection/Isovue-37076%(以碘帕醇计,批准的所有装量)注射剂Bracco Diagnostics Inc未进口原研药品美国橙皮书碘帕醇注射液Iopamidol Injection/Isovue M-300/Isovue -30061%(以碘帕醇计,批准的所有装量)注射剂Bracco Diagnostics Inc未进口原研药品美国橙皮书碘帕醇注射液Iopamidol Injection/Isovue-25051%(以碘帕醇计,批准的所有装量)注射剂Bracco Diagnostics Inc未进口原研药品美国橙皮书碘帕醇注射液Iopamidol Injection/Isovue M-200/Isovue-20041%(以碘帕醇计,批准的所有装量)注射剂Bracco Diagnostics Inc未进口原研药品美国橙皮书氨磺必利片Amisulpride Tablets/Solian50mg片剂Sanofi/Aventis未进口原研药品欧盟上市氨磺必利片Amisulpride Tablets/Solian100mg片剂Sanofi/Aventis未进口原研药品欧盟上市氨磺必利片Amisulpride Tablets/Solian200mg片剂Sanofi/Aventis未进口原研药品欧盟上市氨磺必利片Amisulpride Tablets/Solian400mg片剂Sanofi/Aventis未进口原研药品欧盟上市吸入用硫酸沙丁胺醇溶液Salbutamol Sulfate Inhalation Solution/Ventolin5mg/ml(以沙丁胺醇计)(10、20ml)吸入溶液剂Glaxosmithkline/Glaxo Wellcome未进口原研药品欧盟上市吸入用硫酸沙丁胺醇溶液Albuterol Sulfate Inhalation Solution/Accuneb0.021%或0.63mg/3ml(以沙丁胺醇计)吸入溶液剂Mylan Specialty Lp未进口原研药品美国橙皮书吸入用硫酸沙丁胺醇溶液Albuterol Sulfate Inhalation Solution/Accuneb0.042%或1.25mg/3ml(以沙丁胺醇计)吸入溶液剂Mylan Specialty Lp未进口原研药品美国橙皮书吸入用硫酸沙丁胺醇溶液Albuterol Sulfate Inhalation Solution/-0.083%或2.5mg/3ml(以沙丁胺醇计)吸入溶液剂Nephron Corp国际公认的同种药品美国橙皮书盐酸二甲双胍缓释片Metformin Hydrochloride Sustained-release Tablets/Glucophage Unidie500mg片剂(缓释片)Bruno Farmaceutici S.P.A未进口原研药品欧盟上市他达拉非片Tadalafil Tablets/Cialis5mg片剂Eli Lilly Nederland B.V.未进口原研药品欧盟上市他达拉非片Tadalafil Tablets/Cialis10mg片剂Eli Lilly Nederland B.V.未进口原研药品欧盟上市他达拉非片Tadalafil Tablets/Cialis20mg片剂Eli Lilly Nederland B.V.未进口原研药品欧盟上市他达拉非片Tadalafil Tablets/Cialis5mg片剂Lilly USA, LLC 未进口原研药品美国橙皮书他达拉非片Tadalafil Tablets/Cialis10mg片剂Lilly USA, LLC 未进口原研药品美国橙皮书他达拉非片Tadalafil Tablets/Cialis20mg片剂Lilly USA, LLC 未进口原研药品美国橙皮书阿仑膦酸钠片Alendronate Sodium Tablets/Fosamax10mg片剂Merck and Co Inc未进口原研药品美国橙皮书阿仑膦酸钠片Alendronate Sodium Tablets/Fosamax70mg片剂Merck and Co Inc未进口原研药品美国橙皮书阿戈美拉汀片Agomelatine Tablets/Valdoxan; Thymanax25mg片剂Les Laboratoires Servier.未进口原研药品欧盟上市恩替卡韦片Entecavir Tablets/Baraclude0.5mg片剂Bristol-Myers Squibb Pharma EEIG未进口原研药品欧盟上市恩替卡韦片Entecavir Tablets/Baraclude1mg片剂Bristol-Myers Squibb Pharma EEIG未进口原研药品欧盟上市左氧氟沙星片Levofloxacin Tablets/Cravit250mg片剂第一三共株式会社未进口原研药品日本橙皮书左氧氟沙星片Levofloxacin Tablets/Tavanic250mg片剂Sanofi未进口原研药品欧盟上市左氧氟沙星片Levofloxacin Tablets/Cravit500mg片剂第一三共株式会社未进口原研药品日本橙皮书左氧氟沙星片Levofloxacin Tablets/Tavanic500mg片剂Sanofi未进口原研药品欧盟上市阿立哌唑片Aripiprazole Tablets/Abilify30mg片剂Otsuka Pharmaceutical Co Ltd未进口原研药品美国橙皮书备注1.未在国内上市品种,需参照原总局2015年第230号公告等的相关要求开展研究,通用名、剂型等经药典委核准后为准。2.参比制剂目录公示后,未正式发布的品种将进行专题研究,根据研究结果另行发布。附件2未通过审议的参比制剂品种目录序号药品通用名称英文名称/商品名规格剂型持证商备注1匹多莫德口服溶液Pidotimod Oral Solution/Polimod(普利莫)400mg/7ml/瓶口服溶液剂Polichem S.R.L.经一致性评价专家委员会审议,根据《总局关于匹多莫德口服液启动临床有效性试验的通知》食药监药化管函〔2018〕31号,本品临床有效性证据不足2甲氨蝶呤注射液Methotrexate Injection/Trexject50mg/ml(0.5ml、0.45ml、0.40ml、0.35ml、0.30ml、0.25ml)注射剂Link Medical Products Pty Ltd T/A Link Pharmaceuticals经一致性评价专家委员会审议,已公示原研作为参比制剂3阿加曲班注射液Argatroban Injection20ml: 10mg注射剂沢井製薬株式会社经一致性评价专家委员会审议,本品为改规格品种,已发布原研进口为参比制剂,原研无此规格4阿卡波糖咀嚼片Acarbose Chewable Tablets50mg咀嚼片经一致性评价专家委员会审议,本品为改剂型品种,原研无此剂型5阿卡波糖口崩片Acarbose Chewable Tablets50mg口崩片经一致性评价专家委员会审议,本品为改剂型品种,原研无此剂型6泮托拉唑钠肠溶胶囊Pantoprazole Sodium Enteric-Coated Capsules20mg胶囊剂经一致性评价专家委员会审议,本品为改剂型品种,原研无此剂型7泮托拉唑钠肠溶胶囊Pantoprazole Sodium Enteric-Coated Capsules40mg胶囊剂经一致性评价专家委员会审议,本品为改剂型品种,原研无此剂型8对乙酰氨基酚干混悬剂Paracetamol for Suspension1.01g:0.3g干混悬剂经一致性评价专家委员会审议,本品为改剂型品种,原研无此剂型9注射用脂溶性维生素(Ⅰ)Fat-Soluble Vitamin(I)for Injection复方制剂注射剂经一致性评价专家委员会审议,本品为改剂型品种,原研无此剂型10注射用脂溶性维生素(II)Fat-Soluble Vitamin(II)for Injection复方制剂注射剂经一致性评价专家委员会审议,本品为改剂型品种,原研无此剂型11阿奇霉素颗粒Azithromycin Granules0.1g颗粒剂经一致性评价专家委员会审议,本品为改剂型品种,原研无此剂型12阿奇霉素颗粒Azithromycin Granules0.25g颗粒剂经一致性评价专家委员会审议,本品为改剂型品种,原研无此剂型13盐酸妥洛特罗片Chlobamolie Hydrochloride Tablets1mg片剂经一致性评价专家委员会审议,本品为改规格品种,原研无此规格14帕拉米韦氯化钠注射液Peramivir and Sodium Chloride Injection100ml:帕拉米韦(以C15H28N4O4计)0.15g与氯化钠0.9g注射剂经一致性评价专家委员会审议,本品为改规格品种,原研无此规格15帕拉米韦氯化钠注射液Peramivir and Sodium Chloride Injection100ml:帕拉米韦(以C15H28N4O4计)0.3g与氯化钠0.9g注射剂经一致性评价专家委员会审议,本品为改规格品种,原研无此规格16克霉唑乳膏Clotrimazole Cream3%乳膏剂经一致性评价专家委员会审议,本品为改规格品种,原研无此规格17复方盐酸伪麻黄碱缓释胶囊Compound Pseudoephedrine Hydrochloride Sustained release Capsules每粒含盐酸伪麻黄碱90mg,马来酸氯苯那敏4mg缓释胶囊剂经一致性评价专家委员会审议,本品为改规格品种,原研无此规格18胞磷胆碱钠注射液Citicoline Sodium Injection2ml:0.2g注射剂经一致性评价专家委员会审议,本品为改规格品种,原研无此规格19胞磷胆碱钠注射液Citicoline Sodium Injection5ml:0.5g注射剂经一致性评价专家委员会审议,本品为改规格品种,原研无此规格20胞磷胆碱钠注射液Citicoline Sodium Injection5ml:1g注射剂经一致性评价专家委员会审议,本品为改规格品种,原研无此规格21开塞露(含甘油)Glycerine Enema含甘油42.5%(G:G)灌肠剂经一致性评价专家委员会审议,本品为改规格品种,原研无此规格22倍他米松磷酸钠注射液Betamethasone Sodium Phosphate Injection1ml:2.63mg(相当于倍他米松2mg)注射剂经一致性评价专家委员会审议,本品为改规格品种,原研无此规格 ................
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