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Bosentan Dispersible Tablets/Tracleer（全可利）
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Actelion Pharmaceuticals Ltd
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Siponimod Tablets/ Mayzent（万立能）
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Novartis Pharma Ag/Novartis Pharma Schweiz AG
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Siponimod Tablets/ Mayzent（万立能）
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Novartis Pharma Ag/Novartis Pharma Schweiz AG
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Darolutamide Tablets/ Nubeqa（诺倍戈）
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Bayer Healthcare Pharmaceuticals Inc.
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Multiple Electrolytes Injection/勃脉力A
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Dorzolamide Hydrochloride Timolol Maleate Eye Drops /Cosopt
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含多佐胺20mg/ml（2.0%）和噻吗洛尔5mg/ml（0.5%）
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Technetium[99mtc] Pentetate Injection / Draximage Dtpa
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Jubilant Draximage Inc Dba Jubilant Radiopharma
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Technetium[99mtc] Methylenediphosphonate Injection / Draximage Mdp-25
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Jubilant Draximage Inc Dba Jubilant Radiopharma
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Technetium[99mtc] Sestamibi Injection / Cardiolite
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Lantheus Medical Imaging Inc
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Angiotensin II Injection/Giapreza
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Sirolimus Protein-Bound Particles For Injectable Suspension （Albumin-Bound）/Fyarro
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Belinostat For Injection/ Beleodaq
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Spectrum Pharmaceuticals,Inc./Acrotech Biopharma Llc
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Amoxicillin;Omeprazole Magnesium;Rifabutin Enteric Capsules/Talicia
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奥美拉唑镁（相当于奥美拉唑10mg），阿莫西林250mg，利福布汀12.5mg
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Nitazoxanide For Oral Suspension/Alinia
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Multiple Electrolytes Injection, Type 1/ Plasma-Lyte A Injection PH7.4
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Baxter Healthcare Corporation
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Viloxazine Hydrochloride Extended-Release Capsules / Qelbree
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Viloxazine Hydrochloride Extended-Release Capsules / Qelbree
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Viloxazine Hydrochloride Extended-Release Capsules / Qelbree
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Alendronate Sodium Tablets Solution
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Hikma Pharmaceuticals Usa Inc
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Lidocaine Ointment/ Xylocaine
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Aspen Pharma Trading Limited
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Metronidazole Benzoateoral Suspension / Flagyl
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125mg甲硝唑/5ml（相当于200mg苯酰甲硝唑/5ml）
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Miconazole Nitrate Vaginal Cream
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Janssen/Johnson & Johnson
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Sodium Pertechnetate [99mtc] Injection / ウルトラテクネカウ
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0.925、1.85、2.78、3.70、4.63、5.55、7.40、11.1、14.8、18.5GBq（99Mo-99mTc发生器）
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富士フイルム富山化学株式会社/Pdrファーマ株式会社
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Vitamin D Oral Solution/Uvedose
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Multi-Trace Elements Injection (III)
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Icatibant Acetate Injection
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3ml: 30mg (按C59H89N19O13S计)
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Shire Pharmaceuticals Ireland Limited
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Rivaroxaban Granules For Oral Suspension/ Xarelto
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Rivaroxaban Granules For Oral Suspension/ Xarelto
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Ciclosporin Eye Drops(III)
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Alanyl Glutamine Injection/力太
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Olopatadine Hydrochloride Ophthalmic Solution/Pataday
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Low Magnesium, Low Calcium Peritoneal Dialysis Solution
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Fresenius Medical Care North America
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Low Magnesium, Low Calcium Peritoneal Dialysis Solution
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Fresenius Medical Care North America
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Low Magnesium, Low Calcium Peritoneal Dialysis Solution
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Fresenius Medical Care North America
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Tiotropium Bromide Powder For Inhalation/Spiriva
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18ΜG（按噻托铵计,相当于噻托溴铵一水合物22.5ΜG）
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Boehringer Ingelheim International Gmbh
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Methylthionine Chloride Injection/ Provayblue
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Paliperidone Extend-Release Tablets
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Janssen Pharmaceuticals, Inc.
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Bimatoprost Eye Drops/Lumigan
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Acetazolamide Extended-Release Capsules
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Cadila Healthcare Limited
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Budesonide And Formoterol Fumarate Powder For Inhalation (I) / Symbicort Mite Turbuhaler
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每支60吸，每吸含布地奈德80μg和富马酸福莫特罗4.5μg
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Budesonide And Formoterol Fumarate Powder For Inhalation (II) / Symbicort Turbuhaler
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每支60吸，每吸含布地奈德160μg和富马酸福莫特罗4.5μg
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Budesonide And Formoterol Fumarate Powder For Inhalation (II) / Symbicort Turbuhaler
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每支120吸，每吸含布地奈德160μg和富马酸福莫特罗4.5μg
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Budesonide And Formoterol Fumarate Powder For Inhalation (II) / Symbicort Forte Turbuhaler
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每支60吸，每吸含布地奈德320μg和富马酸福莫特罗9μg
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Cetirizine Dihydrochloride Oral Drops
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Clarithromycin Modified-Release Tablets / Klacid SR）/ Klacid RM/ KLACID UNIDÍA/ Klacid SR/ Klacid Uno/ Klacid LA/ Klacid SR/ Biclar Uno/ Klacid XL
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Mylan Healthcare B.V./ Mylan Italia S.R.L./ Mylan IRE Healthcare Limited/ MYLAN HEALTHCARE Gmbh/ Mylan Healthcare Sp. Z O.O./ Mylan IRE Healthcare Limited/ Mylan EPD Bvba/Sprl/ Mylan IRE Healthcare Limited
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Janssen/Johnson & Johnson
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Sildenafil Citrate Injection/Revatio
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Landiolol Hydrochloride For Injection/Onoact
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Landiolol Hydrochloride For Injection/Onoact
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Mitiglinide Calcium Tablets/Glufast
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Kissei Pharmaceutical Co.,Ltd./キッセイ薬品工業株式会社
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MOVICOL Chocolate 13.9g Sachet, Powder For Oral Solution/ MOVICOL
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Acetylcysteine Injection/Flumil /Fluimucil
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Zambon S.A.U /Zambon Gmbh
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Pasireotide Diaspeartate Injection
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Ursodeoxycholic Acid Tablets/ Delursan
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Ibuprofen Soft Capsules/Advil
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Pfizer Inc/ Glaxosmithkline Consumer Healthcare Holdings Us Llc
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增加持证商Glaxosmithkline Consumer Healthcare Holdings Us Llc
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Lithium Carbonate Tablets/TERALITHE
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Pentoxifylline Modified Release Tablets/Trental
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Aventis Pharma Limited/Sanofi/Sanofi-Produtos Farmaceuticos Lda
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增加持证商Sanofi-Produtos Farmaceuticos Lda
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Doxorubicin Hydrochloride Liposome Injection/Caelyx /Caelyx Pegylated Liposomal
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Janssen-Cilag International NV /Baxter Holding B.V.
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增加持证商Baxter Holding B.V.；增加商品名Caelyx Pegylated Liposomal
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Doxorubicin Hydrochloride Liposome Injection/Caelyx /Caelyx Pegylated Liposomal
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Janssen-Cilag International NV /Baxter Holding B.V.
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增加持证商Baxter Holding B.V.；增加商品名Caelyx Pegylated Liposomal
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Riemser Pharma Gmbh/Esteve Pharmaceuticals Gmbh
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持证商发生变更，增加变更后的持证商Esteve Pharmaceuticals Gmbh
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|
|
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Adapalene And Benzoyl Peroxide Gel/Epiduo
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0.1%;2.5%（包装规格：5g、15g、30g、45g、60g、90g/管和15g、30g、45g、60g/Pump）
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Galderma Nordic AB/ Galderma International S.A.S/ Galderma International/ Galderma Benelux B.V./ Galderma Laboratorium Gmbh/ Laboratorios Galderma S.A./ Galderma Italia S.P.A./ Galderma (UK) Limited
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增加持证商Galderma International S.A.S/ Galderma International/ Galderma Benelux B.V./ Galderma Laboratorium Gmbh/ Laboratorios Galderma S.A./ Galderma Italia S.P.A./ Galderma (UK) Limited
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Eli Lilly Nederland B.V./A. Menarini GmbH
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持证商变更，增加变更后持证商A. Menarini GmbH
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Eli Lilly Nederland B.V./A. Menarini GmbH
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持证商变更，增加变更后持证商A. Menarini GmbH
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Eli Lilly Nederland B.V./A. Menarini GmbH
|
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持证商变更，增加变更后持证商A. Menarini GmbH
|
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Eli Lilly Nederland B.V./A. Menarini GmbH
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持证商变更，增加变更后持证商A. Menarini GmbH
|
|
|
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Melphalan Hydrochloride for Injection/EVOMELA（迈维宁）
|
|
Spectrum Pharmaceuticals, Inc./ Acrotech Biopharma,LLC
|
|
持证商变更，增加变更后持证商Acrotech Biopharma,LLC
|
|
|
|
Mizolastine Sustained Release Tablets /Mizollen（皿治林）
|
|
Therabel Pharmaceuticals Limited/ Therabel Healthcare Limited
|
|
持证商变更，增加变更后持证商Therabel Healthcare Limited
|
|
|
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Entacapone Tablets/Comtan（珂丹）
|
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Orion Pharma AG/Orion Corporation
|
|
持证商变更，增加变更后持证商Orion Corporation
|
|
|
|
Amlodipine and Benazepril Hydrochloride Capsules/Lotrel
|
|
Novartis Pharmaceuticals Corp
|
|
英文名称更新为Amlodipine and Benazepril Hydrochloride Capsules
|
|
|
1.目录中所列尚未在国内上市品种的通用名、剂型等，以药典委核准的为准。
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。
3.欧盟上市的参比制剂包括其在英国上市的同一药品。
4.选择未进口参比制剂开展仿制药研究除满足其质量要求外，还需满足现行版《中国药典》和相关指导原则要求。
5.放射性药物不同于普通化学药物，具有一定的特殊性如放射性、时效性、按放射性活度给药等特点，参比制剂主要用于明确其研发目标和基本要求，可根据其药物特性同时结合参比制剂的可获得性进行研究。
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