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Knowledges

The 60th Batch of Reference Listed Drugs

No. Drug Name/ Brand Name Strength MAH Note 1 Note 2
60-1 Lamivudine and Dolutegravir Sodium Tablets/多伟托 50 mg of dolutegravir and 300 mg of lamivudine ViiV Healthcare B.V. Original drug sold in China Original drug imported to China
60-2 Hemofiltration Replacement Fluid of Sodium Bicarbonate and Phosphate 5000ml(250ml/4750ml) Gambro Lundia AB Original drug sold in China Original drug imported to China
60-3 Miconazole Buccal Tablet/ 诺弥可 50 mg VECTANS PHARMA Original drug sold in China Original drug imported to China
60-4 Lumateperone tosylate capsule/Caplyta 42 mg Intra-Cellular Therapies Inc Original drug not imported to China US Orange Book
60-5 Multiple Electrolytes Injection/Plasma-Lyte A 500ml Baxter Healthcare Corp Original drug not imported to China US Orange Book
60-6 Sodium Bicarbonate Injection 0.9MEQ/ML(7.5%) Exela Pharma Sciences LLC Internationally recognized to be equivalent to the original drug US Orange Book
60-7 Sodium Bicarbonate Injection 1MEQ/ML(8.4%) Exela Pharma Sciences LLC Internationally recognized to be equivalent to the original drug US Orange Book
60-8 Finerenone Tablets/Kerendia 10mg Bayer Healthcare Pharmaceuticals INC Original drug not imported to China US Orange Book
60-9 Finerenone Tablets/Kerendia 20mg Bayer Healthcare Pharmaceuticals INC Original drug not imported to China US Orange Book
60-10 Tafamidis soft Capsules /Vyndamax 61mg Foldrx Pharmaceuticals LLC A Wholly Owned Sub Of Pfizer INC Original drug not imported to China US Orange Book
60-11 Aminocaproic Acid Oral Solution /Amicar 0.25 g/ml Akorn Operating CO LLC Original drug not imported to China US Orange Book
60-12 Vericiguat Tablets/Verquvo 2.5mg Merck Sharp And Dohme Corp Original drug not imported to China US Orange Book
60-13 Vericiguat Tablets/Verquvo 5mg Merck Sharp And Dohme Corp Original drug not imported to China US Orange Book
60-14 Vericiguat Tablets/Verquvo 10mg Merck Sharp And Dohme Corp Original drug not imported to China US Orange Book
60-15 Doxercalciferol Capsules /Hectorol 2.5μg Sanofi Genzyme Original drug not imported to China US Orange Book
60-16 Doxercalciferol Capsules /Hectorol 1μg Sanofi Genzyme Original drug not imported to China US Orange Book
60-17 Doxercalciferol Capsules /Hectorol 0.5μg Sanofi Genzyme Original drug not imported to China US Orange Book
60-18 Prednisolone Sodium phosphate Oral solution/ Pediapred 5mg/5ml Seton Pharmaceutical LLC Original drug not imported to China US Orange Book
60-19 Cyclophosphamide Injection 500mg/2.5ml(200mg/ml) Ingenus Pharmaceuticals,LLC Original drug not imported to China US Orange Book
60-20 Cyclophosphamide Injection 1g/5ml(200mg/ml) Ingenus Pharmaceuticals,LLC Original drug not imported to China US Orange Book
60-21 Cyclophosphamide Injection 2g/10ml(200mg/ml) Ingenus Pharmaceuticals,LLC Original drug not imported to China US Orange Book
60-22 Tofacitinib Citrate Oral Solution 1mg/ml,240ml Pfizer Inc. Original drug not imported to China US Orange Book
60-23 Finasteride and Tadalafil Capsules / Entadfi 5mg/5mg Veru Inc Original drug not imported to China US Orange Book
60-24 Etomidate Injection/Amidate 10ml∶20mg Hospira INC Original drug not imported to China US Orange Book
60-25 Baloxavir Marboxil for Suspension/Xofluza 2mg/ml Genentech Inc. Original drug not imported to China US Orange Book
60-26 Sarecycline Hydrochloride Tablet/Seysara 60mg Almirall LLC Original drug not imported to China US Orange Book
60-27 Sarecycline Hydrochloride Tablet/Seysara 100mg Almirall LLC Original drug not imported to China US Orange Book
60-28 Sarecycline Hydrochloride Tablet/Seysara 150mg Almirall LLC Original drug not imported to China US Orange Book
60-29 Telavancin Hydrochloride for Injection/Vibativ 750 mg Cumberland Pharmaceuticals Inc. Original drug not imported to China US Orange Book
60-30 Tropicamide Ophthalmic Solution/ Mydriacyl 0.50% Sandoz INC Original drug not imported to China US Orange Book
60-31 Amifampridine phosphate tablets/Firdapse 10mg SERB S.A. Original drug not imported to China Sold in the EU
60-32 Bilastine Oral Solution 2.5mg/ml Menarini International Operations Luxembourg S.A./FAES Farma, S.A. Original drug not imported to China Sold in the EU
60-33 Barnidipine Hydrochloride Sustained-Release Capsules / Libradin 10mg Alfasigma S.p.A. Original drug not imported to China Sold in the EU
60-34 Quinagolide Hydrochloride Tablets/Norprolac 25μg Ferring Arzneimittel GmbH Original drug not imported to China Sold in the EU
60-35 Quinagolide Hydrochloride Tablets/Norprolac 50μg Ferring Arzneimittel GmbH Original drug not imported to China Sold in the EU
60-36 Quinagolide Hydrochloride Tablets/Norprolac 75μg Ferring Arzneimittel GmbH Original drug not imported to China Sold in the EU
60-37 Quinagolide Hydrochloride Tablets/Norprolac 150μg Ferring Arzneimittel GmbH Original drug not imported to China Sold in the EU
60-38 Tofacitinib Citrate Oral Solution 1mg/ml,240ml Pfizer Europe MA EEIG Original drug not imported to China Sold in the EU
60-39 Methylthioninium Chloride Enteric-coated Sustained-Release Tablets / Lumeblue 25mg Alfasigma S.p.A.   Sold in the EU
60-40 Isoconazole Nitrate and Diflucortolone Valerate Cream /Travocort®Cream 1%,0.1% LEO Pharma A/S   Sold in the EU
60-41 Mebeverine Hydrochloride Tablets / Colofac 135mg Mylan Products Ltd. Original drug not imported to China Sold in the EU
60-42 Chloral Hydrate Enemas/ Escre 1.34g:0.5g 久光製薬株式会社 Original drug not imported to China Sold in Japan
60-43 Polyethylene Glycol Electrolytes Powder (II)/Niflec 137.155g/packet EAファーマ株式会社 Original drug not imported to China Sold in Japan
60-44 Isoconazole Nitrate Cream/Adestan Cream 1% バイエル薬品株式会社 Original drug not imported to China Sold in Japan
60-45 Lanreotide Acetate Sustained-release Injection (a pre-filled syringe) 60mg Ipsen Pharma Original drug sold in China Original drug imported to China
60-46 Lanreotide Acetate Sustained-release Injection (a pre-filled syringe) 90mg Ipsen Pharma Original drug sold in China Original drug imported to China
60-47 Lanreotide Acetate Sustained-release Injection (a pre-filled syringe) 120mg Ipsen Pharma Original drug sold in China Original drug imported to China
60-48 Alfacalcidol Soft Capsules / Etalpha 1μg CHEPLAPHARM Arzneimittel GmbH Original drug sold in China Original drug imported to China
60-49 Baloxavir Marboxil Tablets/Xofluza(速福达) 40mg Roche Pharma (Schweiz) AG Original drug sold in China Original drug imported to China
60-50 Clopidogrel Hydrogen Sulphate Tablets/Plavix 75mg 赛诺菲(杭州)制药有限公司 Manufactured by the approved original foreign company in China Original drug locally manufactured in China
60-51 Cefoperazone Sodium and Sulbactam Sodium for Injection/舒普深 1.5g(C25H27N9O8S2 1.0g与C8H11NO5S 0.5g) 辉瑞制药有限公司 Manufactured by the approved original foreign company in China Original drug locally manufactured in China
60-52 Cefoperazone Sodium and Sulbactam Sodium for Injection/舒普深 1.0g(C25H27N9O8S2 0.5g与C8H11NO5S 0.5g) 辉瑞制药有限公司 Manufactured by the approved original foreign company in China Original drug locally manufactured in China
60-53 Nilotinib Capsules/Tasigna 50mg Novartis Pharmaceuticals Corp Original drug not imported to China US Orange Book
60-54 Nilotinib Capsules/Tasigna 150mg Novartis Pharmaceuticals Corp Original drug not imported to China US Orange Book
60-55 Nilotinib Capsules/Tasigna 200mg Novartis Pharmaceuticals Corp Original drug not imported to China US Orange Book
60-56 Ketorolac Tromethamine Injection 15mg/ml(1ml:15mg) Hospira INC. Internationally recognized to be equivalent to the original drug US Orange Book
60-57 Ciclosporin Soft Capsules/ Neoral 100mg Novartis Pharmaceuticals Corporation Original drug not imported to China US Orange Book
60-58 Budesonide Suspension For Inhalation/ Pulmicort Respules 2ml:0.5mg Astrazeneca Pharmaceuticals LP Original drug not imported to China US Orange Book
60-59 Budesonide Suspension For Inhalation/ Pulmicort Respules 2ml:1mg Astrazeneca Pharmaceuticals LP Original drug not imported to China US Orange Book
60-60 Hydrochlorothiazide;Olmesartan Medoxomil /Benicar Hct 20mg/12.5mg Daiichi Sankyo Inc Original drug not imported to China US Orange Book
60-61 Ibuprofen Injection/Caldolor 800MG/8ML (100MG/ML) Cumberland Pharmaceuticals Inc Original drug not imported to China US Orange Book
60-62 Faslodex 250 mg solution for injection/Faslodex 5ml:0.25g AstraZeneca AB/AstraZeneca UK Limited Original drug not imported to China Sold in the EU
60-63 Tafamidis Meglumine Soft Capsules/Vyndaqel 20mg Pfizer Europe MA EEIG Original drug not imported to China Sold in the EU
60-64 Entacapone Tablets /Comtess 200mg Orion Pharma GmbH Original drug not imported to China Sold in the EU
60-65 Canagliflozin Tablets/Invokana 300mg Janssen-Cilag International NV, Original drug not imported to China Sold in the EU
60-66 Hydroxychloroquine Sulfate Tablets/Plaquenil 0.2g Sanofi-Aventis Original drug not imported to China Sold in the EU
60-67 Selenium Sulfide Lotion/Selsun 2.50% Sanofi-Aventis Netherlands B.V./ Opella Healthcare France SAS Original drug not imported to China Sold in the EU
60-68 Sevelamer Carbonate Powder for oral suspension/Renvela 0.8g Genzyme Europe B.V. Original drug not imported to China Sold in the EU
60-69 Sevelamer Carbonate Powder for oral suspension/Renvela 2.4g Genzyme Europe B.V. Original drug not imported to China Sold in the EU
60-70 Dalteparin Sodium Injection/Fragmin 0.2ml:2500IU Pfizer Pharma Pfe GmbH Original drug not imported to China Sold in the EU
60-71 Bisacodyl Enteric-coated Tablets/Dulcolax 5mg Opella Healthcare France SAS Original drug not imported to China Sold in the EU
60-72 Venlafaxine Hydrochloride Sustained-Release Capsules/Efexor XL 75mg venlafaxine Upjohn UK Limited Original drug not imported to China Sold in the EU
60-73 Venlafaxine Hydrochloride Sustained-Release Capsules/Efexor XL 150mg venlafaxine Upjohn UK Limited Original drug not imported to China Sold in the EU
60-74 Calcitriol Injection/Rocaltrol 1ml:0.5μg 協和キリン株式会社 Original drug not imported to China Sold in Japan
60-75 Calcitriol Injection/Rocaltrol 1ml:1μg 協和キリン株式会社 Original drug not imported to China Sold in Japan
5-43 Paroxetine Hydrochloride Tablets/Paxil 20mg Apotex Technologies Inc/Apotex Inc Original drug not imported to China Increase License Holder - Apotex Inc
10-132 Pravastatin Sodium Tablet/Sanaprav 40mg DAIICHI SANKYO ITALIA S.p.A./Daiichi Sankyo Belgium S.A/Daiichi Sankyo Europe Gmbh Sold in the EU Increase License Holder - Daiichi Sankyo Belgium S.A/Daiichi Sankyo Europe Gmbh
10-194 Trazodone Hydrochloride Tablets/RESLIN 25mg MSD K.K./オルガノン株式会社 JP Orange Book Increase License Holder - オルガノン株式会社
10-195 Trazodone Hydrochloride Tablets/RESLIN 50mg MSD K.K./オルガノン株式会社 JP Orange Book Increase License Holder - オルガノン株式会社
23-166 Lidocaine Hydrochloride Injection 2%(以C14H22N2O• HCL计)(5ml、10ml、20ml) Aspen/Aspen Pharma Trading Limited Original drug not imported to China Increase License Holder - Aspen Pharma Trading Limited
26-167 Dopamine Hydrochloride Injection/Inovan 2.5ml:50mg 協和発酵キリン株式会社/協和キリン株式会社 Original drug not imported to China Increase License Holder - 協和キリン株式会社
26-168 Dopamine Hydrochloride Injection/Inovan 5ml:100mg 協和発酵キリン株式会社/協和キリン株式会社 Original drug not imported to China Increase License Holder - 協和キリン株式会社
26-1 Fluticasone Propionate Cream/Cutivate 0.05% (15、30、50、100g) Glaxo Wellcome/GlaxoSmithKline/GlaxoSmithKline(Ireland)Limited Original drug not imported to China Increase License Holder - GlaxoSmithKline(Ireland)Limited
26-106 Ezetimibe and Atorvastatin Calcium Trihydrate Tablets 10mg/10mg Merck Sharp & Dohme/Organon Healthcare GmbH /Organon France Original drug not imported to China Increase License Holder - Organon France
26-107 Ezetimibe and Atorvastatin Calcium Trihydrate Tablets 10mg/20mg Merck Sharp & Dohme/Organon Healthcare GmbH /Organon France Original drug not imported to China Increase License Holder - Organon France
27-237 Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection/Voluven Fresenius hydroxyethyl starch130/0.4:60g/L,sodium chloride:9.0g/L(250ml,500ml) Fresenius Kabi Deutschland GmbH/Fresenius Kabi Italia S.r.l./Fresenius Kabi Pharma Portugal, Lda Original drug not imported to China Increase License Holder - Fresenius Kabi Pharma Portugal, Lda,
27-268 Clonazepam Injection 1ml:1mg Roche Pharma(Schweiz)AG/CPS Cito Pharma Services GmbH Original drug not imported to China Increase License Holder - CPS Cito Pharma Services GmbH
27-372 Paroxetine Hydrochloride Tablets/Paxil 40mg Apotex Technologies Inc/Apotex Inc Original drug not imported to China Increase License Holder - Apotex Inc
30-149 Epinephrine Injection/ADRENALIN 1ml:1mg Par Pharmaceutical, Inc/Par Sterile Products Llc Original drug not imported to China Increase License Holder - Par Sterile Products Llc
33-24 Acetylcysteine Oral Solution 2%(50ml、100ml、200ml) Zambon GmbH Original drug not imported to China  
42-48 Paroxetine Hydrochloride Tablets/Paxil 10mg Apotex Technologies Inc/Apotex Inc Original drug not imported to China Increase License Holder - Apotex Inc
42-49 Paroxetine Hydrochloride Tablets/Paxil 30mg Apotex Technologies Inc/Apotex Inc Original drug not imported to China Increase License Holder - Apotex Inc
42-51 Fluticasone Propionate Cream 0.05% Perrigo Israel Pharmaceuticals Ltd / Padagis Israel Pharmaceuticals Ltd Internationally recognized to be equivalent to the original drug Increase License Holder - Padagis Israel Pharmaceuticals Ltd