banner

Knowledges

The 59th Batch of Reference Listed Drugs

No. Drug Name/ Brand Name Strength MAH Note 1 Note 2
59-1 Iron Isomaltoside Injection/ MonoFer® 按Fe计1ml:100mg Pharmacosmos A/S Original drug locally manufactured in China Original drug imported to China
59-2 Iron Isomaltoside Injection/ MonoFer® 按Fe计5ml:500mg Pharmacosmos A/S Original drug locally manufactured in China Original drug imported to China
59-3 Iron Isomaltoside Injection/ MonoFer® 按Fe计10ml:1000mg Pharmacosmos A/S Original drug locally manufactured in China Original drug imported to China
59-4 Deutetrabenazine Tablets/安泰坦 6mg Teva Branded Pharmaceutical Products R&D Inc. Original drug locally manufactured in China Original drug imported to China
59-5 Deutetrabenazine Tablets/安泰坦 9mg Teva Branded Pharmaceutical Products R&D Inc. Original drug locally manufactured in China Original drug imported to China
59-6 Deutetrabenazine Tablets/安泰坦 12mg Teva Branded Pharmaceutical Products R&D Inc. Original drug locally manufactured in China Original drug imported to China
59-7 Doravirine Tablets/Pifeltro(沛卓) 100mg Merck Sharp & Dohme B.V. Original drug locally manufactured in China Original drug imported to China
59-8 Doravirine, Lamivudine and Tenofovir Disoproxil Fumarate Tablets/Delstrigo 每片含多拉韦林100mg、拉米夫定300mg和富马酸替诺福韦二吡呋酯300mg Merck Sharp & Dohme B.V. Original drug locally manufactured in China Original drug imported to China
59-9 Macrogol Sodium Potassium Powder/Movicol(默维可) 13.8g/包 Bridging Pharma Limited Original drug locally manufactured in China Original drug imported to China
59-10 Multiple Electrolytes Injection(Ⅱ) 500ml B. Braun Melsungen AG Original drug locally manufactured in China Original drug imported to China
59-11 Ethosuximide Capsules / Zarontin 250mg Parke Davis Div Warner Lambert Co Original drug not imported to China US Orange Book
59-12 Paroxetine Hydrochloride Oral Suspension/Paxil 10mg/5ml Apotex Corp. Original drug not imported to China US Orange Book
59-13 Calcipotriol Cream /Dovonex 0.01% Leo Pharma As Original drug not imported to China US Orange Book
59-14 Oxymetazoline Hydrochloride Ophthalmic Solution/Upneeq 0.1%(0.3ml:0.3mg) Rvl Pharmaceuticals Inc Original drug not imported to China US Orange Book
59-15 Lactated Ringer's Injection/Lactated Ringer's In Plastic Container 500ml Baxter Healthcare Corp Original drug not imported to China US Orange Book
59-16 Finerenone Tablet/Kerendia 10mg Bayer Healthcare Pharmaceuticals Inc Original drug not imported to China US Orange Book
59-17 Finerenone Tablet/Kerendia 20mg Bayer Healthcare Pharmaceuticals Inc Original drug not imported to China US Orange Book
59-18 Ciclesonide Inhalation Aerosol/Alvesco 0.08MG/INH Covis Pharma Gmbh Original drug not imported to China US Orange Book
59-19 Ciclesonide Inhalation Aerosol/Alvesco 0.16MG/INH Covis Pharma Gmbh Original drug not imported to China US Orange Book
59-20 Vancomycin Hydrochloride Capsules/Vancocin 125mg ANI Pharmaceutical Inc Original drug not imported to China US Orange Book
59-21 Vancomycin Hydrochloride Capsules/Vancocin 250mg ANI Pharmaceutical Inc Original drug not imported to China US Orange Book
59-22 Sorbitol Mannitol Irrigation Solution 3000ml Icu Medical Inc Original drug not imported to China US Orange Book
59-23 Sodium Bicarbonate Injection 0.5MEQ/ML Exela Pharma Sciences Llc Internationally recognized to be equivalent to the original drug US Orange Book
59-24 Biphozyl Solution for haemodialysis / haemofiltration/Biphozyl 22 mmol/l 5000ml(250ml/4750ml) Baxter Holding B.V. Original drug not imported to China Sold in the EU
59-25 Prismasol 2 mmol/l Potassium solution for haemodialysis/haemofiltration/Prismasol 2 mmol/l Potassium 5000ml(250ml/4750ml) Baxter Holding B.V. Original drug not imported to China Sold in the EU
59-26 Dolutegravir and Rilpivirine Tablets 50mg/25mg ViiV Healthcare BV Original drug not imported to China Sold in the EU
59-27 Sterofundin ISO solution for infusion/ Sterofundin ISO 250ml B. Braun Melsungen AG Original drug not imported to China Sold in the EU
59-28 Helicobacter Test Infai 75mg/瓶 Infai GmbH Original drug not imported to China Sold in the EU
59-29 Clotrimazole Vaginal Cream/ Canesten 10% Bayer plc Original drug not imported to China Sold in the EU
59-30 Deferiprone Oral Solution/Ferriprox 1ml:100mg Chiesi Farmaceutici S.p.A. Original drug not imported to China Sold in the EU
59-31 Galanthamine Hydrobromide Oral Solution/Reminyl 4mg/ml Janssen-Cilag AB Original drug not imported to China Sold in the EU
59-32 Ketoprofen 10% Cutaneous Spray/ Ketospray 100mg/ml;12.5ml/瓶和25ml/瓶 Cyathus Exquirere Pharmaforschungs GmbH   Sold in the EU
59-33 Esflurbiprofen Patches /Loqoa Tape 40 mg/贴 (10cm×14cm) 大正製薬株式会社 Original drug not imported to China Sold in Japan
59-34 Arasena-A For Intravenous Infusion 300mg 300mg/瓶 持田製薬株式会社 Original drug not imported to China Sold in Japan
59-35 Anamorelin Hydrochloride Tablets /Adlumiz 50mg 小野薬品工業株式会社 Original drug not imported to China Sold in Japan
59-36 Brexpiprazole Orally Disintegrating Tablets/Rexulti®OD Tablets 0.5mg 大塚製薬株式会社(Otsuka Pharmaceutical Co., Ltd.) Original drug not imported to China Sold in Japan
59-37 Brexpiprazole Orally Disintegrating Tablets/Rexulti®OD Tablets 1mg 大塚製薬株式会社(Otsuka Pharmaceutical Co., Ltd.) Original drug not imported to China Sold in Japan
59-38 Brexpiprazole Orally Disintegrating Tablets/Rexulti®OD Tablets 2mg 大塚製薬株式会社(Otsuka Pharmaceutical Co., Ltd.) Original drug not imported to China Sold in Japan
59-39 Sodium Acetate Ringer's Injection/Veen F Inj. 500ml:氯化钠3.0g,氯化钾0.15g,氯化钙(二水合物)0.10g,醋酸钠(三水合物)1.90g 扶桑薬品工業株式会社 Original drug not imported to China Sold in Japan
59-40 Sodium Potassium Magnesium Calcium and Glucose Injection/Physio 140 250ml 株式会社大塚製薬工場 Original drug not imported to China Sold in Japan
59-41 Sodium Bicarbonate Ringer’s Injection/Bicanate 1000ml 大塚製薬株式会社 Original drug not imported to China Sold in Japan
59-42 Amphotericin B for Oral Suspension /Fungizone 100mg/mL クリニジェン株式会社 Original drug not imported to China Sold in Japan
59-43 Clemastine Fumarate/Tavegal 0.01% 日新製薬株式会社 Original drug not imported to China Sold in Japan
59-44 Powder for Concentrate for Solution for Infusion Clarithromycin/ Klaricid 500mg Mylan Products Limited   Sold in the UK
59-45 Lidocaine Spray/Xylocaine 10mg Spray 10mg/喷,50ml/瓶 Aspen Pharma Trading Limited Original drug not imported to China Sold in the UK
59-46 Movicol Paediatric Chocolate Flavour 6.9g Sachet, Powder For Oral Solution / Movicol 6.9g/袋,含聚乙二醇3350 6.563g;氯化钠:0.1754g;碳酸氢钠:0.0893g;氯化钾:0.0159g Norgine Pharmaceuticals Limited Original drug not imported to China Sold in the UK
59-47 Zonisamide Oral Suspension/Desizon 20mg/ml (250ml:5g) Desitin Arzneimittel GmbH   Sold in the UK
59-48 Strontium [89Sr] Chloride Injection /Metastron(美他特龙) 150MBq(4mCi)/4mL Ge Healthcare Limited Original drug locally manufactured in China Original drug imported to China
59-49 Trazodone Hydrochloride Sustained-release Tablets 150mg Az.Chim.Riun.Angelini Francesco Acraf S.P.A. Original drug locally manufactured in China Original drug imported to China
59-50 Ritonavir Tablets/Norvir 100mg Abbvie Inc Original drug not imported to China US Orange Book
59-51 Sterile Irrigating Solution(balanced salt solution) / BSS 15mL/支每毫升含氯化钠0.64%,氯化钾0.075%,二水合氯化钙0.048%,六水合氯化镁0.030%,三水合醋酸钠0.39%,二水合枸橼酸钠0.17% Alcon Laboratories, Inc Original drug not imported to China US Orange Book
59-52 Dasatinib Tablets/Sprycel 70mg Bristol Myers Squibb Co Original drug not imported to China US Orange Book
59-53 Olopatadine Hydrochloride Ophthalmic solution/Pataday 0.70% Alcon Laboratories Inc Original drug not imported to China US Orange Book
59-54 Empagliflozin and Metformin Hydrochloride Tablets/Synjardy 每片含盐酸二甲双胍500mg和恩格列净12.5mg Boehringer Ingelheim Pharmaceuticals Inc Original drug not imported to China US Orange Book
59-55 Fludeoxyglucose F18 Injection 20-400mCi/ml Feinstein Institute Medical Research Original drug not imported to China US Orange Book
59-56 Naproxen Sodium Tablets /Aleve 200mg(以萘普生计) Bayer Vital Gmbh/ Bayer BV / Bayer (Schweiz) AG Original drug not imported to China Sold in the EU
59-57 Doxofylline Injection 10ml:0.1g Abc Farmaceutici S.P.A Original drug not imported to China Sold in the EU
59-58 Polyethylene Glycol 3350 Electrolytes Powder/Moviprep Orange 抗坏血酸4.7g、聚乙二醇3350 100g、氯化钾1.015g、抗坏血酸钠5.9g、氯化钠2.691g、无水硫酸钠7.5g Norgine B.V. Original drug not imported to China Sold in the EU
59-59 Risperidone Oral Solution/Risperdal 0.1% (100mL:100mg) Janssen Cilag SpA Original drug not imported to China Sold in the EU
59-60 Idarubicin Hydrochloride For Injection 5mg ファイザー株式会社(辉瑞公司) Original drug not imported to China Sold in Japan
59-61 Palbociclib Tablets/イブランス 25mg ファイザー株式会社 Original drug not imported to China Sold in Japan
59-62 Palbociclib Tablets/イブランス 125mg ファイザー株式会社 Original drug not imported to China Sold in Japan
59-63 Dutasteride Soft Capsules/Zagallo Capsules 0.1mg グラクソ・スミスクライン株式会社 Original drug not imported to China Sold in Japan
59-64 Cefteram Pivoxil Tablets/Tomiron 100mg 富士フイルム富山化学株式会社 Original drug not imported to China Sold in Japan
59-65 Cefteram Pivoxil Tablets/Tomiron 50mg 富士フイルム富山化学株式会社 Original drug not imported to China Sold in Japan
59-66 Acetylcysteine Injection/Fluimucil 25ml:5g Zambon Switzerland Ltd Original drug not imported to China Sold in Switzerland
59-67 Acetylcysteine Injection/Fluimucil 3ml:300mg Zambon Switzerland Ltd/Zambon Svizzera SA Original drug not imported to China Sold in Switzerland
10-132 Pravastatin Sodium Tablets/Sanaprav /Prareduct 40mg Daiichi Sankyo Italia S.P.A./Daiichi Sankyo Belgium S.A. Sold in the EU Increase License Holder - Daiichi Sankyo Belgium S.A.
10-272 Phenoxymethylpenicillin Potassium Tablets 0.5g(80万单位) Sandoz GmbH/Sandoz Inc US Orange Book Increase License Holder - Sandoz Inc
23-167 Lidocaine Hydrochloride Topical Solution/Xylocaine Solution 4%(以C14H22N2O·HCl计)(20ml、100ml) アスペンジャパン株式会社/サンドファーマ株式会社 Original drug not imported to China Increase License Holder - サンドファーマ株式会社
45224 Brivaracetam Solution for Injection/Briviact 10mg/ml(5ml) UCB Pharma S.A./UCB Pharma Limited Original drug not imported to China Increase License Holder - UCB Pharma Limited
27-231 Lisdexamfetamine Dimesylate capsules/Vyvanse 30mg Shire Development INC/Takeda Pharmaceuticals USA INC Original drug not imported to China Increase License Holder - Takeda Pharmaceuticals USA INC
27-232 Lisdexamfetamine Dimesylate capsules/Vyvanse 50mg Shire Development INC/Takeda Pharmaceuticals USA INC Original drug not imported to China Increase License Holder - Takeda Pharmaceuticals USA INC
27-233 Lisdexamfetamine Dimesylate capsules/Vyvanse 70mg Shire Development INC/Takeda Pharmaceuticals USA INC Original drug not imported to China Increase License Holder - Takeda Pharmaceuticals USA INC
27-269 Clonazepam Injection/Rivotril 1ml:1mg Roche Pharma AG /Roche/Cheplapharm Arzneimittel Gmbh Original drug not imported to China Increase License Holder - Cheplapharm Arzneimittel Gmbh
29-125 Amoxicillin and Clavulanate Potassium Tablets/Augmentin 0.625g(C16H19N3O5S 0.5g:C8H9NO5 0.125g) Beecham Group /Beecham Group Plc Original drug not imported to China Increase License Holder - Beecham Group Plc
32-16 Compound Sodium Valproate and Valproic Acid Sustained Release Tablets/ Depakine Chrono/Ergenyl chrono 500mg(以丙戊酸钠计) Sanofi Aventis France/Sanofi-Aventis Deutschland GmbH/Sanofi S.p.A. Original drug not imported to China Increase License Holder - Sanofi-Aventis Deutschland GmbH/Sanofi S.p.A.
47-21 Phenoxymethylpenicillin Potassium Tablets 250mg Sandoz GmbH/Sandoz Inc US Orange Book Increase License Holder - Sandoz Inc
10-15 Baclofen Tablets/Lioresal 10mg Novartis Pharma Schweiz AG/Hemony Pharmaceutical Switzerland GmbH Original drug imported to China Licensee change, Increase License Holder - Hemony Pharmaceutical Switzerland GmbH
23-76 Tiotropium Bromide Powder For Inhalation/Spiriva(思力华) 18μg(按噻托铵计,相当于噻托溴铵一水合物22.5μg) Boehringer Ingelheim International GmbH Original drug locally manufactured in China Revised specifications and generic names of drugs