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The 45th Batch of Reference Listed Drugs

No.	Product Name	Brand Name	Strength	MAH	Note 1	Note 2
45-1	Diclofenac Diethylamine Emulgel	Voltarol	2.32%（20g:0.464g, 30g:0.696g, 50g:1.16g, 100g:2.32g）	GlaxoSmithKline Consumer Healthcare (UK) Trading Limited	Original drug not imported to China	Sold in the UK
45-2	Entacapone,Levodopa and Carbidopa Tablets（Ⅱ）		Levodopa 100mg, Carbidopa 25mg, Entacapone 200mg	Orion Corporation	Original drug sold in China	Original drug imported to China
45-3	Structural Fat Emulsion Injection（C6~24）	Structolipid（力文）	250ml: structured triglyceride 50g	Fresenius Kabi AB	Original drug sold in China	Original drug imported to China
45-4	Structural Fat Emulsion Injection（C6~24）	Structolipid（力文）	500ml: structured triglyceride 100g	Fresenius Kabi AB	Original drug sold in China	Original drug imported to China
45-5	Sildenafil Citrate Injection	Revatio	12.5ml:10mg（0.8mg/ml）	Upjohn US 1 LLC	Original drug not imported to China	US Orange Book
45-6	Dapagliflozin And Metformin Hydrochloride Extended-Release Tablets	Xigduo XR	5mg/1000mg	AstraZeneca AB	Original drug not imported to China	US Orange Book
45-7	Dapagliflozin And Metformin Hydrochloride Extended-Release Tablets	Xigduo XR	10mg/1000mg	AstraZeneca AB	Original drug not imported to China	US Orange Book
45-8	Pheniramine Maleate Naphazoline Hydrochloride Eye Drops	Naphcon-A	Pheniramine Maleate 0.3%, Naphazoline Hydrochloride 0.025%	Alcon Laboratories Inc.	Original drug not imported to China	US Orange Book
45-9	Bismuth subcitrate potassium, Metronidazole and Tetracycline Hydrochloride Capsules	Pylera	Bismuth Potassium Subcitrate 140mg/ Tetracycline Hydrochloride 125mg/ Metronidazole 125mg	Allergan Sales LLC	Original drug not imported to China	US Orange Book
45-10	Paracetamol and Ibuprofen Tablets	Advil Dual Action With Acetaminophen	Each tablet contains acetaminophen 250mg, ibuprofen 125mg	Glaxosmithkline Consumer Healthcare Holdings US LLC	Original drug not imported to China	US Orange Book
45-11	Fluticasone Propionate Ointment		0.01%	Perrigo New York Inc	Internationally recognized to be equivalent to the original drug	US Orange Book
45-12	Perampanel oral suspension	Fycompa	0.5mg/ml	Eisai GmbH	Original drug not imported to China	Sold in the EU
45-13	Albuterol Sulfate Syrup	Ventolin	2mg/5ml	GlaxoSmithKline, S.A.	Original drug not imported to China	Sold in the EU
45-14	Palonosetron Hydrochloride Soft Capsules	Aloxi	0.5mg	Helsinn Birex Pharmaceuticals Ltd.	Original drug not imported to China	Sold in the EU
45-15	Gentamicin Sulfate Injection		1ml:40mg	Merck Gesellschaft Mbh/Merck Serono GmbH	Original drug not imported to China	Sold in the EU
45-16	Gentamicin Sulfate Injection		2ml:80mg	Merck Gesellschaft Mbh/Merck Serono GmbH	Original drug not imported to China	Sold in the EU
45-17	Ponatinib Tablets	Iclusig	15mg	大塚製薬株式会社	Original drug not imported to China	Sold in Japan
45-18	Carbazochrome Sodium Sulfonate Tablets	Adona	10mg	ニプロESファーマ株式会社	Original drug not imported to China	Sold in Japan
45-19	Carbazochrome Sodium Sulfonate Tablets	Adona	30mg	ニプロESファーマ株式会社	Original drug not imported to China	Sold in Japan
45-20	Pentazocine Injection		1ml：30mg	丸石製薬株式会社	Original drug not imported to China	Sold in Japan
45-21	Pentazocine Injection		1ml：15mg	丸石製薬株式会社	Original drug not imported to China	Sold in Japan
45-22	Terbutaline Sulfate Syrup		0.5mg/ml	アストラゼネカ株式会社/Astrazeneca	Original drug not imported to China	Sold in Japan
45-23	Calcium Polycarbophil Tablets	Polyful	500mg	マイランEPD合同会社	Original drug not imported to China	Sold in Japan
45-24	Thiamazole Tablets	Thyrozol（赛治）	10mg	Merck Serono GmbH	Original drug sold in China	Original drug imported to China
45-25	Rivaroxaban Tablets	Xarelto	2.5mg	Bayer AG	Original drug sold in China	Original drug imported to China
45-26	Olmesartan Medoxomil and Amlodipine Besylate Tablets		Each tablet contains olmesartan medoxomil 20mg and amlodipine besylate 5mg	DAIICHI SANKYO PHARMACEUTICAL(SHANGHAI)CO.,LTD	Manufactured by the approved original foreign company in China	Original drug locally manufactured in China
45-27	Ceftriaxone Sodium for Injection	罗氏芬	0.25g	Shanghai Roche Pharmaceutical Co., Ltd.	Manufactured by the approved original foreign company in China	Original drug locally manufactured in China
45-28	Ceftriaxone Sodium for Injection	罗氏芬	0.5g	Shanghai Roche Pharmaceutical Co., Ltd.	Manufactured by the approved original foreign company in China	Original drug locally manufactured in China
45-29	Ceftriaxone Sodium for Injection	罗氏芬	1.0g	Shanghai Roche Pharmaceutical Co., Ltd.	Manufactured by the approved original foreign company in China	Original drug locally manufactured in China
45-30	Rabeprazole Sodium Enteric-coated Tablets	Aciphex	20mg	Eisai INC	Original drug not imported to China	US Orange Book
45-31	Metformin Hydrochloride And Empagliflozin Tablets	Synjardy	Each tablet contains Metformin Hydrochloride 1000mg and Empagliflozin 5mg	Boehringer Ingelheim Pharmaceuticals Inc	Original drug not imported to China	US Orange Book
45-32	Metformin Hydrochloride And Empagliflozin Tablets	Synjardy	Each tablet contains Metformin Hydrochloride 1000mg and Empagliflozin 12.5mg	Boehringer Ingelheim Pharmaceuticals Inc	Original drug not imported to China	US Orange Book
45-33	Enzalutamide Tablets		80mg	Astellas Pharma US, Inc.	Original drug not imported to China	US Orange Book
45-34	Enzalutamide Tablets		40mg	Astellas Pharma US, Inc	Original drug not imported to China	US Orange Book
45-35	Bosentan Tablets	Tracleer	125mg	Actelion Pharmaceuticals Ltd	Original drug not imported to China	US Orange Book
45-36	Epinephrine Injection	Epinephrine（Copackaged）	1mg/10mL（0.1mg/mL）	Hospira Inc	Original drug not imported to China	US Orange Book
45-37	Pantoprazole Enteric-Coated Tablets		40mg	Takeda GmbH	Original drug not imported to China	Sold in the EU
45-38	Metformin Hydrochloride And Empagliflozin Tablets	Synjardy	Each tablet contains Metformin Hydrochloride 850mg and Empagliflozin 5mg	Boehringer Ingelheim International GmbH	Original drug not imported to China	Sold in the EU
45-39	Zoledronic Acid Concentrated Solution for Injection	Zometa	5ml:4mg	Novartis Europharm Limited	Original drug not imported to China	Sold in the EU
45-40	Temozolomide Capsules	Temodar	20mg	Merck Sharp & Dohme B.V.	Original drug not imported to China	Sold in the EU
45-41	Temozolomide Capsules	Temodar	100mg	Merck Sharp & Dohme B.V.	Original drug not imported to China	Sold in the EU
45-42	Dexrazoxane for Injection	Cardioxane	500mg	Clinigen Healthcare Ltd	Original drug not imported to China	Sold in the EU
45-43	Esmolol Hydrochloride Injection	Brevibloc	10ml：100mg	Baxter Deutschland GmbH	Original drug not imported to China	Sold in the EU
45-44	Bosentan Tablets	Tracleer	125mg	Janssen-Cilag International NV	Original drug not imported to China	Sold in the EU
45-45	Buprenorphine Hydrochloride and Naloxone Hydrochloride Sublingual Tablets		Buprenorphine 2mg/ Naloxone 0.5mg	Indivior Europe Limited	Original drug not imported to China	Sold in the EU
45-46	Buprenorphine Hydrochloride and Naloxone Hydrochloride Sublingual Tablets		Buprenorphine 8mg/ Naloxone 2mg	Indivior Europe Limited	Original drug not imported to China	Sold in the EU
45-47	Azelastine Hydrochloride Eye Drops	Allergodil	0.5mg/ml（6ml）	MEDA Pharma GmbH & Co. KG	Original drug not imported to China	Sold in the EU
45-48	Amoxicillin and Clavulanate Potassium Tablets	Augmentin	500mg/62.5mg(8:1)	GlaxoSmithKline S.p.A	Original drug not imported to China	Sold in the EU
45-49	Fluorouracil Injection		20ml：0.5g	Hospira UK Limited	Internationally recognized to be equivalent to the original drug	Sold in the EU
45-50	Latanoprost Eye Drops	Xalatan	0.01%	ファイザー株式会社	Original drug not imported to China	Sold in Japan
45-51	Flomoxef Sodium for Injection	Flumarin	1.0g	塩野義製薬株式会社	Original drug not imported to China	Sold in Japan

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