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35
34,,()。
。
:()
/ | 1 | 2 | ||||
---|---|---|---|---|---|---|
| Pinaverium Bromide Tablets/ Dicetel | 50mg | Abbott Laboratories Limited | |||
| Amorolfine Hydrochloride Cream/Loceryl() | 0. 25% | Galderma Laboratorium GmbH | |||
| Isepamicin Sulfate Injection/Exacin() | 2ml:400mg((C22H43N5O12)) | Asahi Kasei Pharma Corporation | |||
| Isepamicin Sulfate Injection/Exacin() | 2ml:200mg((C22H43N5O12)) | Asahi Kasei Pharma Corporation | |||
| Memantine Hydrochloride Extended-release and Donepezil Hydrochloride Capsules/Namzaric | 7mg/10mg | Allergan Sales LLC | No imported original research drugs | American Orange Book | |
| Memantine Hydrochloride and Donepezil Sustained Release Capsules | Memantine Hydrochloride Extended-release and Donepezil Hydrochloride Capsules/Namzaric | 14mg/10mg | Allergan Sales LLC | No imported original research drugs | American Orange Book |
| Memantine Hydrochloride and Donepezil Sustained Release Capsules | Memantine Hydrochloride Extended-release and Donepezil Hydrochloride Capsules/Namzaric | 21mg/10mg | Allergan Sales LLC | No imported original research drugs | American Orange Book |
| Memantine Hydrochloride and Donepezil Sustained Release Capsules | Memantine Hydrochloride Extended-release and Donepezil Hydrochloride Capsules/Namzaric | 28mg/10mg | Allergan Sales LLC | No imported original research drugs | American Orange Book |
| Lysinoprofen injection | Ibuprofen Lysine Injection/NeoProfen | 20mg/2ml | Recordati Rare Diseases Inc. | No imported original research drugs | American Orange Book |
| Bendamustine Hydrochloride Injection | Bendamustine Hydrochloride Injection/Belrapzo | 100mg/4ml (25mg/ml) | Eagle Pharmaceuticals, Inc. | No imported original research drugs | American Orange Book |
| Midotulin Capsules | Midostaurin Capsules/Rydapt | 25mg | Novartis Pharmaceuticals Corporation | No imported original research drugs | American Orange Book |
| Minocycline Hydrochloride Sustained Release Tablets | Minocycline Hydrochloride Extended Release Tablets/Solodyn | 55mg | Medicis Pharmaceutical Corp | No imported original research drugs | American Orange Book |
| Minocycline Hydrochloride Sustained Release Tablets | Minocycline Hydrochloride Extended Release Tablets/Solodyn | 65mg | Medicis Pharmaceutical Corp | No imported original research drugs | American Orange Book |
| Minocycline Hydrochloride Sustained Release Tablets | Minocycline Hydrochloride Extended Release Tablets/Solodyn | 80mg | Medicis Pharmaceutical Corp | No imported original research drugs | American Orange Book |
| Minocycline Hydrochloride Sustained Release Tablets | Minocycline Hydrochloride Extended Release Tablets/Solodyn | 105mg | Medicis Pharmaceutical Corp | No imported original research drugs | American Orange Book |
| Minocycline Hydrochloride Sustained Release Tablets | Minocycline Hydrochloride Extended Release Tablets/Solodyn | 115mg | Medicis Pharmaceutical Corp | No imported original research drugs | American Orange Book |
| Phenylephrine Hydrochloride Eye Drops | Phenylephrine Hydrochloride Ophthalmic Solution | 2. 5% | Akorn Operating Co Llc | No imported original research drugs | American Orange Book |
| Phenylephrine Hydrochloride Eye Drops | Phenylephrine Hydrochloride Ophthalmic Solution | 10% | Akorn Operating Co Llc | No imported original research drugs | American Orange Book |
| Orlistat Chewable Tablets | Orlistat Chewable Tablet/Alli | 27mg | GlaxoSmithKline (Ireland) Limited | No imported original research drugs | EU listing |
| Edaravone injection | Edaravone Injection | 100ml: 30mg | Mitsubishi Tanabe Pharma Corporation | Original research drugs marketed in China | Original research import |
| Avatropol maleate tablets | Avatrombopag Maleate Tablets/Doptelet (Su Kexin) | 20mg | AkaRx Inc. | Original research drugs marketed in China | Original research import |
| Digoxin Tablets | Digoxin Tablets/Lanoxin | 0. 125mg | Concordia Pharmaceuticals Inc | No imported original research drugs | American Orange Book |
| Olopatadine Hydrochloride Eye Drops | Olopatadine Hydrochloride ophthalmic solution 0. 2%/ Pataday | 0. 2% | Alcon Laboratories Inc | No imported original research drugs | American Orange Book |
| Quetiapine Fumarate Tablets | Quetiapine Fumarate Tablets/ Seroquel | 25mg | AstraZeneca Pharmaceuticals LP | No imported original research products | American Orange Book |
| Quetiapine Fumarate Tablets | Quetiapine Fumarate Tablets/ Seroquel | 300mg | AstraZeneca Pharmaceuticals LP | No imported original research products | American Orange Book |
| Salmeterol ticasone inhalation powder | Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation/Advair Diskus | 100mcg/50mcg | Glaxo Smith Kline | No imported original research drugs | American Orange Book |
| Salmeterol ticasone inhalation powder | Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation/Advair Diskus | 250mcg/50mcg | Glaxo Smith Kline | No imported original research drugs | American Orange Book |
| Salmeterol ticasone inhalation powder | Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation/Advair Diskus | 500mcg/50mcg | Glaxo Smith Kline | No imported original research drugs | American Orange Book |
| Salmeterol ticasone inhalation powder | Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation/Seretide Diskus | 50mcg/100mcg | Glaxo Wellcome UK Ltd | No imported original research drugs | EU listing |
| Salmeterol ticasone inhalation powder | Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation/Seretide Diskus | 50mcg/250mcg | Glaxo Wellcome UK Ltd | No imported original research drugs | EU listing |
| Salmeterol ticasone inhalation powder | Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation/Seretide Diskus | 50mcg/500mcg | Glaxo Wellcome UK Ltd | No imported original research drugs | EU listing |
| Ranolazine sustained-release tablets | Ranolazine Prolonged-Release Tablets /Ranexa | 500mg | Menarini International Operations Luxembourg SA | No imported original research drugs | EU listing |
| Cross-linked sodium hyaluronate injection | Hyaluronic acid, stabilized single injection/ Durolane | 3 ml: Sodium Hyaluronate 60mg | Bioventus LLC | No imported original research drugs | EU listing |
| Teriflunomide Tablets | Teriflunomide Tablets/Aubagio | 14mg | Sanofi-Aventis Groupe | No imported original research drugs | EU listing |
| Memantine Hydrochloride Tablets | Memantine Hydrochloride Tablets/Ebixa | 5mg | H. Lundbeck A/S | No imported original research drugs | EU listing |
| Memantine Hydrochloride Tablets | Memantine Hydrochloride Tablets/Ebixa | 15mg | H. Lundbeck A/S | No imported original research drugs | EU listing |
| Medium and long-chain fat emulsion/amino acid (16)/glucose (30%) injection | Medium and Long Chain Fat Emulsion / Amino Acids (16) / Glucose (30%) Injection/NuTRIflex Lipid plus | 1875ml | B. Braun Melsungen AG | No imported original research drugs | EU listing |
| Fat milk amino acid (17) glucose (19%) injection | Fat Emulsion, Amino Acids (17) And Glucose (19%) Injection/Kabiven | 2053ml | Fresenius Kabi | Internationally recognized drugs of the same kind | EU listing |
| Levothyroxine Sodium Tablets | Levothyroxine Sodium Tablets | 200μg | Merck Serono GmbH/Merck Sante/Merck Gesellschaft mbH | No imported original research drugs | EU listing |
| Eplerenone tablets | Eplerenone Tablets | 25mg | ファイザー Co. , Ltd. | No imported original research drugs | Listed in Japan |
| Eplerenone tablets | Eplerenone Tablets | 50mg | ファイザー Co. , Ltd. | No imported original research drugs | Listed in Japan |
| Eplerenone tablets | Eplerenone Tablets | 100mg | ファイザー Co. , Ltd. | No imported original research drugs | Listed in Japan |
| Tandospirone Citrate Tablets | Tandospirone Citrate Tablets | 5mg | Dainippon Sumitomo Pharmaceutical Co. , Ltd. | Unimported original research | Listed in Japan |
| Allopurinol Tablets | Allopurinol Tablets / Zyloric | 50mg | グラクソ・スミスクライン Co. , Ltd. | No imported original research drugs | Listed in Japan |
| Allopurinol Tablets | Allopurinol Tablets / Zyloric | 100mg | グラクソ・スミスクライン Co. , Ltd. | No imported original research drugs | Listed in Japan |
| Perampanel tablets | Perampanel Tablets/Fycompa | 2mg | Eisai Inc/ Eisai Europe Limited | No imported original research drugs | UK listed |
| Perampanel tablets | Perampanel Tablets/Fycompa | 4mg | Eisai Inc/ Eisai Europe Limited | No imported original research drugs | UK listed |
| Perampanel tablets | Perampanel Tablets/Fycompa | 8mg | Eisai Inc/ Eisai Europe Limited | No imported original research drugs | UK listed |
| Perampanel tablets | Perampanel Tablets/Fycompa | 12mg | Eisai Inc/ Eisai Europe Limited | No imported original research drugs | UK listed |
| Morphine Sulfate/ Sustained Release Tablets | Morphine Sulphate Sustained-release Tablets | 30mg | Napp Pharmaceuticals Limited | No imported original research drugs | UK listed |
| Lamotrigine Dispersible Tablets | Lamotrigine Dispersible Tablets/Lamictal | 2mg | The Wellcome Foundation Ltd. | No imported original research drugs | UK listed |
7-25 | Acetaminophen tablets | Paracetamol Tablets/Panadol Advance Tablets | 0. 5g | GlaxoSmithKline Consumer Healthcare | 1“(:;:)”“” | |
7-88 | Bromhexine Hydrochloride Tablets/Bisolvon | 8mg | Boehringer Ingelheim Pharma GmbH & Co. KG/Sanofi-Aventis Deutschland GmbH | ,Sanofi-Aventis Deutschland GmbH | ||
23-219 | (17)(19%) | Fat Emulsion,Amino Acids(17) And Glucose(19%) Injection/Kabiven | 1026ml | Fresenius Kabi AB | Fresenius Kabi AB | |
23-220 | (17)(19%) | Fat Emulsion,Amino Acids(17) And Glucose(19%) Injection/Kabiven | 2053ml | Fresenius Kabi AB | Fresenius Kabi AB | |
27-104 | Milrinone Injection /Primacor 1mg/ml Solution for Injection | 10mg/10ml | Aventis Pharma Limited/Sanofi-Aventis/Sanofi | 10mg/10ml | ||
1. ,2015230,、。 2. ,,。 3. 。 4. ,《》。 |
202131
35
34,,()。
。
:()
/ | 1 | 2 | ||||
---|---|---|---|---|---|---|
| Pinaverium Bromide Tablets/ Dicetel | 50mg | Abbott Laboratories Limited | |||
| Amorolfine Hydrochloride Cream/Loceryl() | 0. 25% | Galderma Laboratorium GmbH | |||
| Isepamicin Sulfate Injection/Exacin() | 2ml:400mg((C22H43N5O12)) | Asahi Kasei Pharma Corporation | |||
| Isepamicin Sulfate Injection/Exacin() | 2ml:200mg((C22H43N5O12)) | Asahi Kasei Pharma Corporation | |||
| Memantine Hydrochloride Extended-release and Donepezil Hydrochloride Capsules/Namzaric | 7mg/10mg | Allergan Sales LLC | |||
| Memantine Hydrochloride Extended-release and Donepezil Hydrochloride Capsules/Namzaric | 14mg/10mg | Allergan Sales LLC | |||
| Memantine Hydrochloride Extended-release and Donepezil Hydrochloride Capsules/Namzaric | 21mg/10mg | Allergan Sales LLC | |||
| Memantine Hydrochloride Extended-release and Donepezil Hydrochloride Capsules/Namzaric | 28mg/10mg | Allergan Sales LLC | |||
| Ibuprofen Lysine Injection/NeoProfen | 20mg/2ml | Recordati Rare Diseases Inc. | |||
| Bendamustine Hydrochloride Injection/Belrapzo | 100mg/4ml(25mg/ml) | Eagle Pharmaceuticals, Inc. | |||
| Midostaurin Capsules/Rydapt | 25mg | Novartis Pharmaceuticals Corporation | |||
| Minocycline Hydrochloride Extended Release Tablets/Solodyn | 55mg | Medicis Pharmaceutical Corp | |||
| Minocycline Hydrochloride Extended Release Tablets/Solodyn | 65mg | Medicis Pharmaceutical Corp | |||
| Minocycline Hydrochloride Extended Release Tablets/Solodyn | 80mg | Medicis Pharmaceutical Corp | |||
| Minocycline Hydrochloride Extended Release Tablets/Solodyn | 105mg | Medicis Pharmaceutical Corp | |||
| Minocycline Hydrochloride Extended Release Tablets/Solodyn | 115mg | Medicis Pharmaceutical Corp | |||
| Phenylephrine Hydrochloride Ophthalmic Solution | 2. 5% | Akorn Operating Co Llc | |||
| Phenylephrine Hydrochloride Ophthalmic Solution | 10% | Akorn Operating Co Llc | |||
| Orlistat Chewable Tablet/Alli | 27mg | GlaxoSmithKline (Ireland)Limited | |||
| Edaravone Injection | 100ml:30mg | Mitsubishi Tanabe Pharma Corporation | |||
| Avatrombopag Maleate Tablets/Doptelet() | 20mg | AkaRx Inc. | |||
| Digoxin Tablets/Lanoxin | 0. 125mg | Concordia Pharmaceuticals Inc | |||
| Olopatadine Hydrochloride ophthalmic solution 0. 2%/ Pataday | 0. 2% | Alcon Laboratories Inc | |||
| Quetiapine Fumarate Tablets/ Seroquel | 25mg | AstraZeneca Pharmaceuticals LP | |||
| Quetiapine Fumarate Tablets/ Seroquel | 300mg | AstraZeneca Pharmaceuticals LP | |||
| Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation/Advair Diskus | 100mcg/50mcg | Glaxo Smith Kline | |||
| Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation/Advair Diskus | 250mcg/50mcg | Glaxo Smith Kline | |||
| Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation/Advair Diskus | 500mcg/50mcg | Glaxo Smith Kline | |||
| Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation/Seretide Diskus | 50mcg/100mcg | Glaxo Wellcome UK Ltd | |||
| Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation/Seretide Diskus | 50mcg/250mcg | Glaxo Wellcome UK Ltd | |||
| Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation/Seretide Diskus | 50mcg/500mcg | Glaxo Wellcome UK Ltd | |||
| Ranolazine Prolonged-Release Tablets /Ranexa | 500mg | Menarini International Operations Luxembourg S. A | |||
| Hyaluronic acid, stabilized single injection/ Durolane | 3 ml:60mg | Bioventus LLC | |||
| Teriflunomide Tablets/Aubagio | 14mg | Sanofi-Aventis Groupe | |||
| Memantine Hydrochloride Tablets/Ebixa | 5mg | H. Lundbeck A/S | |||
| Memantine Hydrochloride Tablets/Ebixa | 15mg | H. Lundbeck A/S | |||
| /(16)/(30%) | Medium and Long Chain Fat Emulsion / Amino Acids (16) / Glucose (30%) Injection/NuTRIflex Lipid plus | 1875ml | B. Braun Melsungen AG | ||
| (17)(19%) | Fat Emulsion, Amino Acids(17) And Glucose(19%) Injection/Kabiven | 2053ml | Fresenius Kabi | ||
| Levothyroxine Sodium Tablets | 200μg | Merck Serono GmbH/Merck Sante/Merck Gesellschaft mbH | |||
| Eplerenone Tablets | 25mg | ファイザー | |||
| Eplerenone Tablets | 50mg | ファイザー | |||
| Eplerenone Tablets | 100mg | ファイザー | |||
| Tandospirone Citrate Tablets | 5mg | ||||
| Allopurinol Tablets / Zyloric | 50mg | グラクソ・スミスクライン | |||
| Allopurinol Tablets / Zyloric | 100mg | グラクソ・スミスクライン | |||
| Perampanel Tablets/Fycompa | 2mg | Eisai Inc/ Eisai Europe Limited | |||
| Perampanel Tablets/Fycompa | 4mg | Eisai Inc/ Eisai Europe Limited | |||
| Perampanel Tablets/Fycompa | 8mg | Eisai Inc/ Eisai Europe Limited | |||
| Perampanel Tablets/Fycompa | 12mg | Eisai Inc/ Eisai Europe Limited | |||
| // | Morphine Sulphate Sustained-release Tablets | 30mg | Napp Pharmaceuticals Limited | ||
| Lamotrigine Dispersible Tablets/Lamictal | 2mg | The Wellcome Foundation Ltd. | |||
7-25 | Paracetamol Tablets/Panadol Advance Tablets | 0. 5g | GlaxoSmithKline Consumer Healthcare | 1“(:;:)”“” | ||
7-88 | Bromhexine Hydrochloride Tablets/Bisolvon | 8mg | Boehringer Ingelheim Pharma GmbH & Co. KG/Sanofi-Aventis Deutschland GmbH | ,Sanofi-Aventis Deutschland GmbH | ||
23-219 | (17)(19%) | Fat Emulsion,Amino Acids(17) And Glucose(19%) Injection/Kabiven | 1026ml | Fresenius Kabi AB | Fresenius Kabi AB | |
23-220 | (17)(19%) | Fat Emulsion,Amino Acids(17) And Glucose(19%) Injection/Kabiven | 2053ml | Fresenius Kabi AB | Fresenius Kabi AB | |
27-104 | Milrinone Injection /Primacor 1mg/ml Solution for Injection | 10mg/10ml | Aventis Pharma Limited/Sanofi-Aventis/Sanofi | 10mg/10ml | ||
1. ,2015230,、。 2. ,,。 3. 。 4. ,《》。 |
202131
34,,()。
。
:()
:() / | 1 | 2 | ||||
---|---|---|---|---|---|---|
| Pinaverium Bromide Tablets/ Dicetel | 50mg | Abbott Laboratories Limited | |||
| Amorolfine Hydrochloride Cream/Loceryl() | 0. 25% | Galderma Laboratorium GmbH | |||
| Isepamicin Sulfate Injection/Exacin() | 2ml:400mg((C22H43N5O12)) | Asahi Kasei Pharma Corporation | |||
| Isepamicin Sulfate Injection/Exacin() | 2ml:200mg((C22H43N5O12)) | Asahi Kasei Pharma Corporation | |||
| Memantine Hydrochloride Extended-release and Donepezil Hydrochloride Capsules/Namzaric | 7mg/10mg | Allergan Sales LLC | |||
| Memantine Hydrochloride Extended-release and Donepezil Hydrochloride Capsules/Namzaric | 14mg/10mg | Allergan Sales LLC | |||
| Memantine Hydrochloride Extended-release and Donepezil Hydrochloride Capsules/Namzaric | 21mg/10mg | Allergan Sales LLC | |||
| Memantine Hydrochloride Extended-release and Donepezil Hydrochloride Capsules/Namzaric | 28mg/10mg | Allergan Sales LLC | |||
| Ibuprofen Lysine Injection/NeoProfen | 20mg/2ml | Recordati Rare Diseases Inc. | |||
| Bendamustine Hydrochloride Injection/Belrapzo | 100mg/4ml(25mg/ml) | Eagle Pharmaceuticals, Inc. | |||
| Midostaurin Capsules/Rydapt | 25mg | Novartis Pharmaceuticals Corporation | |||
| Minocycline Hydrochloride Extended Release Tablets/Solodyn | 55mg | Medicis Pharmaceutical Corp | |||
| Minocycline Hydrochloride Extended Release Tablets/Solodyn | 65mg | Medicis Pharmaceutical Corp | |||
| Minocycline Hydrochloride Extended Release Tablets/Solodyn | 80mg | Medicis Pharmaceutical Corp | |||
| Minocycline Hydrochloride Extended Release Tablets/Solodyn | 105mg | Medicis Pharmaceutical Corp | |||
| Minocycline Hydrochloride Extended Release Tablets/Solodyn | 115mg | Medicis Pharmaceutical Corp | |||
| Phenylephrine Hydrochloride Ophthalmic Solution | 2. 5% | Akorn Operating Co Llc | |||
| Phenylephrine Hydrochloride Ophthalmic Solution | 10% | Akorn Operating Co Llc | |||
| Orlistat Chewable Tablet/Alli | 27mg | GlaxoSmithKline (Ireland)Limited | |||
| Edaravone Injection | 100ml:30mg | Mitsubishi Tanabe Pharma Corporation | |||
| Avatrombopag Maleate Tablets/Doptelet() | 20mg | AkaRx Inc. | |||
| Digoxin Tablets/Lanoxin | 0. 125mg | Concordia Pharmaceuticals Inc | |||
| Olopatadine Hydrochloride ophthalmic solution 0. 2%/ Pataday | 0. 2% | Alcon Laboratories Inc | |||
| Quetiapine Fumarate Tablets/ Seroquel | 25mg | AstraZeneca Pharmaceuticals LP | |||
| Quetiapine Fumarate Tablets/ Seroquel | 300mg | AstraZeneca Pharmaceuticals LP | |||
| Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation/Advair Diskus | 100mcg/50mcg | Glaxo Smith Kline | |||
| Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation/Advair Diskus | 250mcg/50mcg | Glaxo Smith Kline | |||
| Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation/Advair Diskus | 500mcg/50mcg | Glaxo Smith Kline | |||
| Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation/Seretide Diskus | 50mcg/100mcg | Glaxo Wellcome UK Ltd | |||
| Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation/Seretide Diskus | 50mcg/250mcg | Glaxo Wellcome UK Ltd | |||
| Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation/Seretide Diskus | 50mcg/500mcg | Glaxo Wellcome UK Ltd | |||
| Ranolazine Prolonged-Release Tablets /Ranexa | 500mg | Menarini International Operations Luxembourg S. A | |||
| Hyaluronic acid, stabilized single injection/ Durolane | 3 ml:60mg | Bioventus LLC | |||
| Teriflunomide Tablets/Aubagio | 14mg | Sanofi-Aventis Groupe | |||
| Memantine Hydrochloride Tablets/Ebixa | 5mg | H. Lundbeck A/S | |||
| Memantine Hydrochloride Tablets/Ebixa | 15mg | H. Lundbeck A/S | |||
| /(16)/(30%) | Medium and Long Chain Fat Emulsion / Amino Acids (16) / Glucose (30%) Injection/NuTRIflex Lipid plus | 1875ml | B. Braun Melsungen AG | ||
| (17)(19%) | Fat Emulsion, Amino Acids(17) And Glucose(19%) Injection/Kabiven | 2053ml | Fresenius Kabi | ||
| Levothyroxine Sodium Tablets | 200μg | Merck Serono GmbH/Merck Sante/Merck Gesellschaft mbH | |||
| Eplerenone Tablets | 25mg | ファイザー | |||
| Eplerenone Tablets | 50mg | ファイザー | |||
| Eplerenone Tablets | 100mg | ファイザー | |||
| Tandospirone Citrate Tablets | 5mg | ||||
| Allopurinol Tablets / Zyloric | 50mg | グラクソ・スミスクライン | |||
| Allopurinol Tablets / Zyloric | 100mg | グラクソ・スミスクライン | |||
| Perampanel Tablets/Fycompa | 2mg | Eisai Inc/ Eisai Europe Limited | |||
| Perampanel Tablets/Fycompa | 4mg | Eisai Inc/ Eisai Europe Limited | |||
| Perampanel Tablets/Fycompa | 8mg | Eisai Inc/ Eisai Europe Limited | |||
| Perampanel Tablets/Fycompa | 12mg | Eisai Inc/ Eisai Europe Limited | |||
| // | Morphine Sulphate Sustained-release Tablets | 30mg | Napp Pharmaceuticals Limited | ||
| Lamotrigine Dispersible Tablets/Lamictal | 2mg | The Wellcome Foundation Ltd. | |||
7-25 | Paracetamol Tablets/Panadol Advance Tablets | 0. 5g | GlaxoSmithKline Consumer Healthcare | 1“(:;:)”“” | ||
7-88 | Bromhexine Hydrochloride Tablets/Bisolvon | 8mg | Boehringer Ingelheim Pharma GmbH & Co. KG/Sanofi-Aventis Deutschland GmbH | ,Sanofi-Aventis Deutschland GmbH | ||
23-219 | (17)(19%) | Fat Emulsion,Amino Acids(17) And Glucose(19%) Injection/Kabiven | 1026ml | Fresenius Kabi AB | Fresenius Kabi AB | |
23-220 | (17)(19%) | Fat Emulsion,Amino Acids(17) And Glucose(19%) Injection/Kabiven | 2053ml | Fresenius Kabi AB | Fresenius Kabi AB | |
27-104 | Milrinone Injection /Primacor 1mg/ml Solution for Injection | 10mg/10ml | Aventis Pharma Limited/Sanofi-Aventis/Sanofi | 10mg/10ml | ||
1. ,2015230,、。 2. ,,。 3. 。 4. ,《》。 |
/ | 1 | 2 | ||||
---|---|---|---|---|---|---|
| Pinaverium Bromide Tablets/ Dicetel | 50mg | Abbott Laboratories Limited | Original research drugs marketed in China | Original research import | |
| Amorolfine Hydrochloride Cream | Amorolfine Hydrochloride Cream/Loceryl | 0. 25% | Galderma Laboratorium GmbH | Original research drugs marketed in China | Original research import |
| Isepamicin Sulfate Injection | Isepamicin Sulfate Injection/Exacin (Yikesha) | 2ml: 400mg (calculated as Isepamicin (C22H43N5O12)) | Asahi Kasei Pharma Corporation | Original research drugs marketed in China | Original research import |
| Isepamicin Sulfate Injection | Isepamicin Sulfate Injection/Exacin (Yikesha) | 2ml:200mg (calculated as isepamicin (C22H43N5O12)) | Asahi Kasei Pharma Corporation | Original research drugs marketed in China | Original research import |
| Memantine Hydrochloride and Donepezil Sustained Release Capsules | Memantine Hydrochloride Extended-release and Donepezil Hydrochloride Capsules/Namzaric | 7mg/10mg | Allergan Sales LLC | No imported original research drugs | American Orange Book |
| Memantine Hydrochloride and Donepezil Sustained Release Capsules | Memantine Hydrochloride Extended-release and Donepezil Hydrochloride Capsules/Namzaric | 14mg/10mg | Allergan Sales LLC | No imported original research drugs | American Orange Book |
| Memantine Hydrochloride and Donepezil Sustained Release Capsules | Memantine Hydrochloride Extended-release and Donepezil Hydrochloride Capsules/Namzaric | 21mg/10mg | Allergan Sales LLC | No imported original research drugs | American Orange Book |
| Memantine Hydrochloride and Donepezil Sustained Release Capsules | Memantine Hydrochloride Extended-release and Donepezil Hydrochloride Capsules/Namzaric | 28mg/10mg | Allergan Sales LLC | No imported original research drugs | American Orange Book |
| Lysinoprofen injection | Ibuprofen Lysine Injection/NeoProfen | 20mg/2ml | Recordati Rare Diseases Inc. | No imported original research drugs | American Orange Book |
| Bendamustine Hydrochloride Injection | Bendamustine Hydrochloride Injection/Belrapzo | 100mg/4ml (25mg/ml) | Eagle Pharmaceuticals, Inc. | No imported original research drugs | American Orange Book |
| Midotulin Capsules | Midostaurin Capsules/Rydapt | 25mg | Novartis Pharmaceuticals Corporation | No imported original research drugs | American Orange Book |
| Minocycline Hydrochloride Sustained Release Tablets | Minocycline Hydrochloride Extended Release Tablets/Solodyn | 55mg | Medicis Pharmaceutical Corp | No imported original research drugs | American Orange Book |
| Minocycline Hydrochloride Sustained Release Tablets | Minocycline Hydrochloride Extended Release Tablets/Solodyn | 65mg | Medicis Pharmaceutical Corp | No imported original research drugs | American Orange Book |
| Minocycline Hydrochloride Sustained Release Tablets | Minocycline Hydrochloride Extended Release Tablets/Solodyn | 80mg | Medicis Pharmaceutical Corp | No imported original research drugs | American Orange Book |
| Minocycline Hydrochloride Sustained Release Tablets | Minocycline Hydrochloride Extended Release Tablets/Solodyn | 105mg | Medicis Pharmaceutical Corp | No imported original research drugs | American Orange Book |
| Minocycline Hydrochloride Sustained Release Tablets | Minocycline Hydrochloride Extended Release Tablets/Solodyn | 115mg | Medicis Pharmaceutical Corp | No imported original research drugs | American Orange Book |
| Phenylephrine Hydrochloride Eye Drops | Phenylephrine Hydrochloride Ophthalmic Solution | 2. 5% | Akorn Operating Co Llc | No imported original research drugs | American Orange Book |
| Phenylephrine Hydrochloride Eye Drops | Phenylephrine Hydrochloride Ophthalmic Solution | 10% | Akorn Operating Co Llc | No imported original research drugs | American Orange Book |
| Orlistat Chewable Tablets | Orlistat Chewable Tablet/Alli | 27mg | GlaxoSmithKline (Ireland) Limited | No imported original research drugs | EU listing |
| Edaravone injection | Edaravone Injection | 100ml: 30mg | Mitsubishi Tanabe Pharma Corporation | Original research drugs marketed in China | Original research import |
| Avatropol maleate tablets | Avatrombopag Maleate Tablets/Doptelet (Su Kexin) | 20mg | AkaRx Inc. | Original research drugs marketed in China | Original research import |
| Digoxin Tablets | Digoxin Tablets/Lanoxin | 0. 125mg | Concordia Pharmaceuticals Inc | No imported original research drugs | American Orange Book |
| Olopatadine Hydrochloride Eye Drops | Olopatadine Hydrochloride ophthalmic solution 0. 2%/ Pataday | 0. 2% | Alcon Laboratories Inc | No imported original research drugs | American Orange Book |
| Quetiapine Fumarate Tablets | Quetiapine Fumarate Tablets/ Seroquel | 25mg | AstraZeneca Pharmaceuticals LP | No imported original research products | American Orange Book |
| Quetiapine Fumarate Tablets | Quetiapine Fumarate Tablets/ Seroquel | 300mg | AstraZeneca Pharmaceuticals LP | No imported original research products | American Orange Book |
| Salmeterol ticasone inhalation powder | Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation/Advair Diskus | 100mcg/50mcg | Glaxo Smith Kline | No imported original research drugs | American Orange Book |
| Salmeterol ticasone inhalation powder | Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation/Advair Diskus | 250mcg/50mcg | Glaxo Smith Kline | No imported original research drugs | American Orange Book |
| Salmeterol ticasone inhalation powder | Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation/Advair Diskus | 500mcg/50mcg | Glaxo Smith Kline | No imported original research drugs | American Orange Book |
| Salmeterol ticasone inhalation powder | Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation/Seretide Diskus | 50mcg/100mcg | Glaxo Wellcome UK Ltd | No imported original research drugs | EU listing |
| Salmeterol ticasone inhalation powder | Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation/Seretide Diskus | 50mcg/250mcg | Glaxo Wellcome UK Ltd | No imported original research drugs | EU listing |
| Salmeterol ticasone inhalation powder | Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation/Seretide Diskus | 50mcg/500mcg | Glaxo Wellcome UK Ltd | No imported original research drugs | EU listing |
| Ranolazine sustained-release tablets | Ranolazine Prolonged-Release Tablets /Ranexa | 500mg | Menarini International Operations Luxembourg SA | No imported original research drugs | EU listing |
| Cross-linked sodium hyaluronate injection | Hyaluronic acid, stabilized single injection/ Durolane | 3 ml: Sodium Hyaluronate 60mg | Bioventus LLC | No imported original research drugs | EU listing |
| Teriflunomide Tablets | Teriflunomide Tablets/Aubagio | 14mg | Sanofi-Aventis Groupe | No imported original research drugs | EU listing |
| Memantine Hydrochloride Tablets | Memantine Hydrochloride Tablets/Ebixa | 5mg | H. Lundbeck A/S | No imported original research drugs | EU listing |
| Memantine Hydrochloride Tablets | Memantine Hydrochloride Tablets/Ebixa | 15mg | H. Lundbeck A/S | No imported original research drugs | EU listing |
| Medium and long-chain fat emulsion/amino acid (16)/glucose (30%) injection | Medium and Long Chain Fat Emulsion / Amino Acids (16) / Glucose (30%) Injection/NuTRIflex Lipid plus | 1875ml | B. Braun Melsungen AG | No imported original research drugs | EU listing |
| Fat milk amino acid (17) glucose (19%) injection | Fat Emulsion, Amino Acids (17) And Glucose (19%) Injection/Kabiven | 2053ml | Fresenius Kabi | Internationally recognized drugs of the same kind | EU listing |
| Levothyroxine Sodium Tablets | Levothyroxine Sodium Tablets | 200μg | Merck Serono GmbH/Merck Sante/Merck Gesellschaft mbH | No imported original research drugs | EU listing |
| Eplerenone tablets | Eplerenone Tablets | 25mg | ファイザー Co. , Ltd. | No imported original research drugs | Listed in Japan |
| Eplerenone tablets | Eplerenone Tablets | 50mg | ファイザー Co. , Ltd. | No imported original research drugs | Listed in Japan |
| Eplerenone tablets | Eplerenone Tablets | 100mg | ファイザー Co. , Ltd. | No imported original research drugs | Listed in Japan |
| Tandospirone Citrate Tablets | Tandospirone Citrate Tablets | 5mg | Dainippon Sumitomo Pharmaceutical Co. , Ltd. | Unimported original research | Listed in Japan |
| Allopurinol Tablets | Allopurinol Tablets / Zyloric | 50mg | グラクソ・スミスクライン Co. , Ltd. | No imported original research drugs | Listed in Japan |
| Allopurinol Tablets | Allopurinol Tablets / Zyloric | 100mg | グラクソ・スミスクライン Co. , Ltd. | No imported original research drugs | Listed in Japan |
| Perampanel tablets | Perampanel Tablets/Fycompa | 2mg | Eisai Inc/ Eisai Europe Limited | No imported original research drugs | UK listed |
| Perampanel tablets | Perampanel Tablets/Fycompa | 4mg | Eisai Inc/ Eisai Europe Limited | No imported original research drugs | UK listed |
| Perampanel tablets | Perampanel Tablets/Fycompa | 8mg | Eisai Inc/ Eisai Europe Limited | No imported original research drugs | UK listed |
| Perampanel tablets | Perampanel Tablets/Fycompa | 12mg | Eisai Inc/ Eisai Europe Limited | No imported original research drugs | UK listed |
| Morphine Sulfate/ Sustained Release Tablets | Morphine Sulphate Sustained-release Tablets | 30mg | Napp Pharmaceuticals Limited | ||
| Lamotrigine Dispersible Tablets/Lamictal | 2mg | The Wellcome Foundation Ltd. | |||
7-25 | Paracetamol Tablets/Panadol Advance Tablets | 0. 5g | GlaxoSmithKline Consumer Healthcare | 1“(:;:)”“” | ||
7-88 | Bromhexine Hydrochloride Tablets/Bisolvon | 8mg | Boehringer Ingelheim Pharma GmbH & Co. KG/Sanofi-Aventis Deutschland GmbH | ,Sanofi-Aventis Deutschland GmbH | ||
23-219 | (17)(19%) | Fat Emulsion,Amino Acids(17) And Glucose(19%) Injection/Kabiven | 1026ml | Fresenius Kabi AB | Fresenius Kabi AB | |
23-220 | (17)(19%) | Fat Emulsion,Amino Acids(17) And Glucose(19%) Injection/Kabiven | 2053ml | Fresenius Kabi AB | Fresenius Kabi AB | |
27-104 | Milrinone Injection /Primacor 1mg/ml Solution for Injection | 10mg/10ml | Aventis Pharma Limited/Sanofi-Aventis/Sanofi | 10mg/10ml | ||
1. ,2015230,、。 2. ,,。 3. 。 4. ,《》。 |
/
1
2
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1
2
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2
2
Pinaverium Bromide Tablets/ Dicetel
50mg
Abbott Laboratories Limited
Original research drugs marketed in China
Original research import
Amorolfine Hydrochloride Cream
Amorolfine Hydrochloride Cream/Loceryl
0.
25%
25%
Galderma Laboratorium GmbH
Original research drugs marketed in China
Original research import
Isepamicin Sulfate Injection
Isepamicin Sulfate Injection/Exacin (Yikesha)
2ml: 400mg (calculated as Isepamicin (C22H43N5O12))
Asahi Kasei Pharma Corporation
Original research drugs marketed in China
Original research import
Isepamicin Sulfate Injection
Isepamicin Sulfate Injection/Exacin (Yikesha)
2ml:200mg (calculated as isepamicin (C22H43N5O12))
Asahi Kasei Pharma Corporation
Original research drugs marketed in China
Original research import
Memantine Hydrochloride and Donepezil Sustained Release Capsules
Memantine Hydrochloride Extended-release and Donepezil Hydrochloride Capsules/Namzaric
7mg/10mg
Allergan Sales LLC
No imported original research drugs
American Orange Book
Memantine Hydrochloride and Donepezil Sustained Release Capsules
Memantine Hydrochloride Extended-release and Donepezil Hydrochloride Capsules/Namzaric
14mg/10mg
Allergan Sales LLC
No imported original research drugs
American Orange Book
Memantine Hydrochloride and Donepezil Sustained Release Capsules
Memantine Hydrochloride Extended-release and Donepezil Hydrochloride Capsules/Namzaric
21mg/10mg
Allergan Sales LLC
No imported original research drugs
American Orange Book
Memantine Hydrochloride and Donepezil Sustained Release Capsules
Memantine Hydrochloride Extended-release and Donepezil Hydrochloride Capsules/Namzaric
28mg/10mg
Allergan Sales LLC
No imported original research drugs
American Orange Book
Lysinoprofen injection
Ibuprofen Lysine Injection/NeoProfen
20mg/2ml
Recordati Rare Diseases Inc.
No imported original research drugs
American Orange Book
Bendamustine Hydrochloride Injection
Bendamustine Hydrochloride Injection/Belrapzo
100mg/4ml (25mg/ml)
Eagle Pharmaceuticals, Inc.
No imported original research drugs
American Orange Book
Midotulin Capsules
Midostaurin Capsules/Rydapt
25mg
Novartis Pharmaceuticals Corporation
No imported original research drugs
American Orange Book
Minocycline Hydrochloride Sustained Release Tablets
Minocycline Hydrochloride Extended Release Tablets/Solodyn
55mg
Medicis Pharmaceutical Corp
No imported original research drugs
American Orange Book
Minocycline Hydrochloride Sustained Release Tablets
Minocycline Hydrochloride Extended Release Tablets/Solodyn
65mg
Medicis Pharmaceutical Corp
No imported original research drugs
American Orange Book
Minocycline Hydrochloride Sustained Release Tablets
Minocycline Hydrochloride Extended Release Tablets/Solodyn
80mg
Medicis Pharmaceutical Corp
No imported original research drugs
American Orange Book
Minocycline Hydrochloride Sustained Release Tablets
Minocycline Hydrochloride Extended Release Tablets/Solodyn
105mg
Medicis Pharmaceutical Corp
No imported original research drugs
American Orange Book
Minocycline Hydrochloride Sustained Release Tablets
Minocycline Hydrochloride Extended Release Tablets/Solodyn
115mg
Medicis Pharmaceutical Corp
No imported original research drugs
American Orange Book
Phenylephrine Hydrochloride Eye Drops
Phenylephrine Hydrochloride Ophthalmic Solution
2.
5%
5%
Akorn Operating Co Llc
No imported original research drugs
American Orange Book
Phenylephrine Hydrochloride Eye Drops
Phenylephrine Hydrochloride Ophthalmic Solution
10%
Akorn Operating Co Llc
No imported original research drugs
American Orange Book
Orlistat Chewable Tablets
Orlistat Chewable Tablet/Alli
27mg
GlaxoSmithKline (Ireland) Limited
No imported original research drugs
EU listing
Edaravone injection
Edaravone Injection
100ml: 30mg
Mitsubishi Tanabe Pharma Corporation
Original research drugs marketed in China
Original research import
Avatropol maleate tablets
Avatrombopag Maleate Tablets/Doptelet (Su Kexin)
20mg
AkaRx Inc.
Original research drugs marketed in China
Original research import
Digoxin Tablets
Digoxin Tablets/Lanoxin
0.
125mg
125mg
Concordia Pharmaceuticals Inc
No imported original research drugs
American Orange Book
Olopatadine Hydrochloride Eye Drops
Olopatadine Hydrochloride ophthalmic solution 0.
2%/ Pataday
2%/ Pataday
0.
2%
2%
Alcon Laboratories Inc
No imported original research drugs
American Orange Book
Quetiapine Fumarate Tablets
Quetiapine Fumarate Tablets/ Seroquel
25mg
AstraZeneca Pharmaceuticals LP
No imported original research products
American Orange Book
Quetiapine Fumarate Tablets
Quetiapine Fumarate Tablets/ Seroquel
300mg
AstraZeneca Pharmaceuticals LP
No imported original research products
American Orange Book
Salmeterol ticasone inhalation powder
Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation/Advair Diskus
100mcg/50mcg
Glaxo Smith Kline
No imported original research drugs
American Orange Book
Salmeterol ticasone inhalation powder
Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation/Advair Diskus
250mcg/50mcg
Glaxo Smith Kline
No imported original research drugs
American Orange Book
Salmeterol ticasone inhalation powder
Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation/Advair Diskus
500mcg/50mcg
Glaxo Smith Kline
No imported original research drugs
American Orange Book
Salmeterol ticasone inhalation powder
Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation/Seretide Diskus
50mcg/100mcg
Glaxo Wellcome UK Ltd
No imported original research drugs
EU listing
Salmeterol ticasone inhalation powder
Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation/Seretide Diskus
50mcg/250mcg
Glaxo Wellcome UK Ltd
No imported original research drugs
EU listing
Salmeterol ticasone inhalation powder
Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation/Seretide Diskus
50mcg/500mcg
Glaxo Wellcome UK Ltd
No imported original research drugs
EU listing
Ranolazine sustained-release tablets
Ranolazine Prolonged-Release Tablets /Ranexa
500mg
Menarini International Operations Luxembourg SA
No imported original research drugs
EU listing
Cross-linked sodium hyaluronate injection
Hyaluronic acid, stabilized single injection/ Durolane
3 ml: Sodium Hyaluronate 60mg
Bioventus LLC
No imported original research drugs
EU listing
Teriflunomide Tablets
Teriflunomide Tablets/Aubagio
14mg
Sanofi-Aventis Groupe
No imported original research drugs
EU listing
Memantine Hydrochloride Tablets
Memantine Hydrochloride Tablets/Ebixa
5mg
H.
Lundbeck A/S
Lundbeck A/S
No imported original research drugs
EU listing
Memantine Hydrochloride Tablets
Memantine Hydrochloride Tablets/Ebixa
15mg
H.
Lundbeck A/S
Lundbeck A/S
No imported original research drugs
EU listing
Medium and long-chain fat emulsion/amino acid (16)/glucose (30%) injection
Medium and Long Chain Fat Emulsion / Amino Acids (16) / Glucose (30%) Injection/NuTRIflex Lipid plus
1875ml
B.
Braun Melsungen AG
Braun Melsungen AG
No imported original research drugs
EU listing
Fat milk amino acid (17) glucose (19%) injection
Fat Emulsion, Amino Acids (17) And Glucose (19%) Injection/Kabiven
2053ml
Fresenius Kabi
Internationally recognized drugs of the same kind
EU listing
Levothyroxine Sodium Tablets
Levothyroxine Sodium Tablets
200μg
Merck Serono GmbH/Merck Sante/Merck Gesellschaft mbH
No imported original research drugs
EU listing
Eplerenone tablets
Eplerenone Tablets
25mg
ファイザー Co.
, Ltd.
, Ltd.
No imported original research drugs
Listed in Japan
Eplerenone tablets
Eplerenone Tablets
50mg
ファイザー Co.
, Ltd.
, Ltd.
No imported original research drugs
Listed in Japan
Eplerenone tablets
Eplerenone Tablets
100mg
ファイザー Co.
, Ltd.
, Ltd.
No imported original research drugs
Listed in Japan
Tandospirone Citrate Tablets
Tandospirone Citrate Tablets
5mg
Dainippon Sumitomo Pharmaceutical Co.
, Ltd.
, Ltd.
Unimported original research
Listed in Japan
Allopurinol Tablets
Allopurinol Tablets / Zyloric
50mg
グラクソ・スミスクライン Co.
, Ltd.
, Ltd.
No imported original research drugs
Listed in Japan
Allopurinol Tablets
Allopurinol Tablets / Zyloric
100mg
グラクソ・スミスクライン Co.
, Ltd.
, Ltd.
No imported original research drugs
Listed in Japan
Perampanel tablets
Perampanel Tablets/Fycompa
2mg
Eisai Inc/
Eisai Europe Limited
No imported original research drugs
UK listed
Perampanel tablets
Perampanel Tablets/Fycompa
4mg
Eisai Inc/
Eisai Europe Limited
No imported original research drugs
UK listed
Perampanel tablets
Perampanel Tablets/Fycompa
8mg
Eisai Inc/
Eisai Europe Limited
No imported original research drugs
UK listed
Perampanel tablets
Perampanel Tablets/Fycompa
12mg
Eisai Inc/
Eisai Europe Limited
No imported original research drugs
UK listed
Morphine Sulfate/ Sustained Release Tablets
Morphine Sulphate Sustained-release Tablets
30mg
Napp Pharmaceuticals Limited
No imported original research drugs
UK listed
Lamotrigine Dispersible Tablets
Lamotrigine Dispersible Tablets/Lamictal
2mg
The Wellcome Foundation Ltd.
No imported original research drugs
UK listed
7-25
Acetaminophen tablets
Paracetamol Tablets/Panadol Advance Tablets
0.
5g
5g
GlaxoSmithKline Consumer Healthcare
EU listing
Remark 1 is revised from "European Union listing (listed country: UK; place of origin: Germany)" to "European Union listing"
7-88
Bromhexine Hydrochloride Tablets
Bromhexine Hydrochloride Tablets/Bisolvon
8mg
Boehringer Ingelheim Pharma GmbH & Co.
KG/Sanofi-Aventis Deutschland GmbH
KG/Sanofi-Aventis Deutschland GmbH
No imported original research drugs
The license holder changes and the license holder Sanofi-Aventis Deutschland GmbH is added
23-219
Fat milk amino acid (17) glucose (19%) injection
Fat Emulsion, Amino Acids (17) And Glucose (19%) Injection/Kabiven
1026ml
Fresenius Kabi AB
Internationally recognized drugs on the domestic market
The licensee is updated to Fresenius Kabi AB
23-220
Fat milk amino acid (17) glucose (19%) injection
Fat Emulsion, Amino Acids (17) And Glucose (19%) Injection/Kabiven
2053ml
Fresenius Kabi AB
Internationally recognized drugs on the domestic market
The licensee is updated to Fresenius Kabi AB
27-104
Milrinone Injection
Milrinone Injection /Primacor 1mg/ml Solution for Injection
10mg/10ml
Aventis Pharma Limited/Sanofi-Aventis/Sanofi
No imported original research drugs
Specification updated to 10mg/10ml
Remarks
1.
For products that are not on the domestic market, research needs to be carried out in accordance with the relevant requirements of the original Food and Drug Administration Announcement No.
230 in 2015.
The generic name, dosage form, etc.
shall prevail after the approval of the Pharmacopoeia Commission.
For products that are not on the domestic market, research needs to be carried out in accordance with the relevant requirements of the original Food and Drug Administration Announcement No.
230 in 2015.
The generic name, dosage form, etc.
shall prevail after the approval of the Pharmacopoeia Commission.
2.
After the publication of the reference preparation catalogue, the varieties that have not been officially released will be subject to special research and will be released separately according to the research results.
After the publication of the reference preparation catalogue, the varieties that have not been officially released will be subject to special research and will be released separately according to the research results.
3.
The reference preparations marketed in the EU include the same drugs marketed in the UK.
The reference preparations marketed in the EU include the same drugs marketed in the UK.
4.
The selection of unimported reference preparations to carry out generic drug research not only meets its quality requirements, but also needs to meet the requirements of the current version of the Chinese Pharmacopoeia and related guidelines.
The selection of unimported reference preparations to carry out generic drug research not only meets its quality requirements, but also needs to meet the requirements of the current version of the Chinese Pharmacopoeia and related guidelines.
Pinaverium Bromide Tablets
Pinaverium Bromide Tablets/ Dicetel
50mg
Abbott Laboratories Limited
Original research drugs marketed in China
Original research import
Pinaverium Bromide Tablets
Pinaverium Bromide Tablets
Pinaverium Bromide Tablets/ Dicetel
Pinaverium Bromide Tablets/ Dicetel
50mg
50mg
Abbott Laboratories Limited
Abbott Laboratories Limited
Original research drugs marketed in China
Original research drugs marketed in China
Original research import
Original research import
Amorolfine Hydrochloride Cream
Amorolfine Hydrochloride Cream/Loceryl
0.
25%
25%
Galderma Laboratorium GmbH
Original research drugs marketed in China
Original research import
Amorolfine Hydrochloride Cream
Amorolfine Hydrochloride Cream
Amorolfine Hydrochloride Cream/Loceryl
Amorolfine Hydrochloride Cream/Loceryl
0.
25%
25%
0.
25%
25%
Galderma Laboratorium GmbH
Galderma Laboratorium GmbH
Original research drugs marketed in China
Original research drugs marketed in China
Original research import
Original research import
Isepamicin Sulfate Injection
Isepamicin Sulfate Injection/Exacin (Yikesha)
2ml: 400mg (calculated as Isepamicin (C22H43N5O12))
Asahi Kasei Pharma Corporation
Original research drugs marketed in China
Original research import
Isepamicin Sulfate Injection
Isepamicin Sulfate Injection
Isepamicin Sulfate Injection/Exacin (Yikesha)
Isepamicin Sulfate Injection/Exacin (Yikesha)
2ml: 400mg (calculated as Isepamicin (C22H43N5O12))
2ml: 400mg (calculated as Isepamicin (C22H43N5O12))
Asahi Kasei Pharma Corporation
Asahi Kasei Pharma Corporation
Original research drugs marketed in China
Original research drugs marketed in China
Original research import
Original research import
Isepamicin Sulfate Injection
Isepamicin Sulfate Injection/Exacin (Yikesha)
2ml:200mg (calculated as isepamicin (C22H43N5O12))
Asahi Kasei Pharma Corporation
Original research drugs marketed in China
Original research import
Isepamicin Sulfate Injection
Isepamicin Sulfate Injection
Isepamicin Sulfate Injection/Exacin (Yikesha)
Isepamicin Sulfate Injection/Exacin (Yikesha)
2ml:200mg (calculated as isepamicin (C22H43N5O12))
2ml:200mg (calculated as isepamicin (C22H43N5O12))
Asahi Kasei Pharma Corporation
Asahi Kasei Pharma Corporation
Original research drugs marketed in China
Original research drugs marketed in China
Original research import
Original research import
Memantine Hydrochloride and Donepezil Sustained Release Capsules
Memantine Hydrochloride Extended-release and Donepezil Hydrochloride Capsules/Namzaric
7mg/10mg
Allergan Sales LLC
No imported original research drugs
American Orange Book
Memantine Hydrochloride and Donepezil Sustained Release Capsules
Memantine Hydrochloride and Donepezil Sustained Release Capsules
Memantine Hydrochloride Extended-release and Donepezil Hydrochloride Capsules/Namzaric
Memantine Hydrochloride Extended-release and Donepezil Hydrochloride Capsules/Namzaric
7mg/10mg
7mg/10mg
Allergan Sales LLC
Allergan Sales LLC
No imported original research drugs
No imported original research drugs
American Orange Book
American Orange Book
Memantine Hydrochloride and Donepezil Sustained Release Capsules
Memantine Hydrochloride Extended-release and Donepezil Hydrochloride Capsules/Namzaric
14mg/10mg
Allergan Sales LLC
No imported original research drugs
American Orange Book
Memantine Hydrochloride and Donepezil Sustained Release Capsules
Memantine Hydrochloride and Donepezil Sustained Release Capsules
Memantine Hydrochloride Extended-release and Donepezil Hydrochloride Capsules/Namzaric
Memantine Hydrochloride Extended-release and Donepezil Hydrochloride Capsules/Namzaric
14mg/10mg
14mg/10mg
Allergan Sales LLC
Allergan Sales LLC
No imported original research drugs
No imported original research drugs
American Orange Book
American Orange Book
Memantine Hydrochloride and Donepezil Sustained Release Capsules
Memantine Hydrochloride Extended-release and Donepezil Hydrochloride Capsules/Namzaric
21mg/10mg
Allergan Sales LLC
No imported original research drugs
American Orange Book
Memantine Hydrochloride and Donepezil Sustained Release Capsules
Memantine Hydrochloride and Donepezil Sustained Release Capsules
Memantine Hydrochloride Extended-release and Donepezil Hydrochloride Capsules/Namzaric
Memantine Hydrochloride Extended-release and Donepezil Hydrochloride Capsules/Namzaric
21mg/10mg
21mg/10mg
Allergan Sales LLC
Allergan Sales LLC
No imported original research drugs
No imported original research drugs
American Orange Book
American Orange Book
Memantine Hydrochloride and Donepezil Sustained Release Capsules
Memantine Hydrochloride Extended-release and Donepezil Hydrochloride Capsules/Namzaric
28mg/10mg
Allergan Sales LLC
No imported original research drugs
American Orange Book
Memantine Hydrochloride and Donepezil Sustained Release Capsules
Memantine Hydrochloride and Donepezil Sustained Release Capsules
Memantine Hydrochloride Extended-release and Donepezil Hydrochloride Capsules/Namzaric
Memantine Hydrochloride Extended-release and Donepezil Hydrochloride Capsules/Namzaric
28mg/10mg
28mg/10mg
Allergan Sales LLC
Allergan Sales LLC
No imported original research drugs
No imported original research drugs
American Orange Book
American Orange Book
Lysinoprofen injection
Ibuprofen Lysine Injection/NeoProfen
20mg/2ml
Recordati Rare Diseases Inc.
No imported original research drugs
American Orange Book
Lysinoprofen injection
Lysinoprofen injection
Ibuprofen Lysine Injection/NeoProfen
Ibuprofen Lysine Injection/NeoProfen
20mg/2ml
20mg/2ml
Recordati Rare Diseases Inc.
Recordati Rare Diseases Inc.
No imported original research drugs
No imported original research drugs
American Orange Book
American Orange Book
Bendamustine Hydrochloride Injection
Bendamustine Hydrochloride Injection/Belrapzo
100mg/4ml (25mg/ml)
Eagle Pharmaceuticals, Inc.
No imported original research drugs
American Orange Book
Bendamustine Hydrochloride Injection
Bendamustine Hydrochloride Injection
Bendamustine Hydrochloride Injection/Belrapzo
Bendamustine Hydrochloride Injection/Belrapzo
100mg/4ml (25mg/ml)
100mg/4ml (25mg/ml)
Eagle Pharmaceuticals, Inc.
Eagle Pharmaceuticals, Inc.
No imported original research drugs
No imported original research drugs
American Orange Book
American Orange Book
Midotulin Capsules
Midostaurin Capsules/Rydapt
25mg
Novartis Pharmaceuticals Corporation
No imported original research drugs
American Orange Book
Midotulin Capsules
Midotulin Capsules
Midostaurin Capsules/Rydapt
Midostaurin Capsules/Rydapt
25mg
25mg
Novartis Pharmaceuticals Corporation
Novartis Pharmaceuticals Corporation
No imported original research drugs
No imported original research drugs
American Orange Book
American Orange Book
Minocycline Hydrochloride Sustained Release Tablets
Minocycline Hydrochloride Extended Release Tablets/Solodyn
55mg
Medicis Pharmaceutical Corp
No imported original research drugs
American Orange Book
Minocycline Hydrochloride Sustained Release Tablets
Minocycline Hydrochloride Sustained Release Tablets
Minocycline Hydrochloride Extended Release Tablets/Solodyn
Minocycline Hydrochloride Extended Release Tablets/Solodyn
55mg
55mg
Medicis Pharmaceutical Corp
Medicis Pharmaceutical Corp
No imported original research drugs
No imported original research drugs
American Orange Book
American Orange Book
Minocycline Hydrochloride Sustained Release Tablets
Minocycline Hydrochloride Extended Release Tablets/Solodyn
65mg
Medicis Pharmaceutical Corp
No imported original research drugs
American Orange Book
Minocycline Hydrochloride Sustained Release Tablets
Minocycline Hydrochloride Sustained Release Tablets
Minocycline Hydrochloride Extended Release Tablets/Solodyn
Minocycline Hydrochloride Extended Release Tablets/Solodyn
65mg
65mg
Medicis Pharmaceutical Corp
Medicis Pharmaceutical Corp
No imported original research drugs
No imported original research drugs
American Orange Book
American Orange Book
Minocycline Hydrochloride Sustained Release Tablets
Minocycline Hydrochloride Extended Release Tablets/Solodyn
80mg
Medicis Pharmaceutical Corp
No imported original research drugs
American Orange Book
Minocycline Hydrochloride Sustained Release Tablets
Minocycline Hydrochloride Sustained Release Tablets
Minocycline Hydrochloride Extended Release Tablets/Solodyn
Minocycline Hydrochloride Extended Release Tablets/Solodyn
80mg
80mg
Medicis Pharmaceutical Corp
Medicis Pharmaceutical Corp
No imported original research drugs
No imported original research drugs
American Orange Book
American Orange Book
Minocycline Hydrochloride Sustained Release Tablets
Minocycline Hydrochloride Extended Release Tablets/Solodyn
105mg
Medicis Pharmaceutical Corp
No imported original research drugs
American Orange Book
Minocycline Hydrochloride Sustained Release Tablets
Minocycline Hydrochloride Sustained Release Tablets
Minocycline Hydrochloride Extended Release Tablets/Solodyn
Minocycline Hydrochloride Extended Release Tablets/Solodyn
105mg
105mg
Medicis Pharmaceutical Corp
Medicis Pharmaceutical Corp
No imported original research drugs
No imported original research drugs
American Orange Book
American Orange Book
Minocycline Hydrochloride Sustained Release Tablets
Minocycline Hydrochloride Extended Release Tablets/Solodyn
115mg
Medicis Pharmaceutical Corp
No imported original research drugs
American Orange Book
Minocycline Hydrochloride Sustained Release Tablets
Minocycline Hydrochloride Sustained Release Tablets
Minocycline Hydrochloride Extended Release Tablets/Solodyn
Minocycline Hydrochloride Extended Release Tablets/Solodyn
115mg
115mg
Medicis Pharmaceutical Corp
Medicis Pharmaceutical Corp
No imported original research drugs
No imported original research drugs
American Orange Book
American Orange Book
Phenylephrine Hydrochloride Eye Drops
Phenylephrine Hydrochloride Ophthalmic Solution
2.
5%
5%
Akorn Operating Co Llc
No imported original research drugs
American Orange Book
Phenylephrine Hydrochloride Eye Drops
Phenylephrine Hydrochloride Eye Drops
Phenylephrine Hydrochloride Ophthalmic Solution
Phenylephrine Hydrochloride Ophthalmic Solution
2.
5%
5%
2.
5%
5%
Akorn Operating Co Llc
Akorn Operating Co Llc
No imported original research drugs
No imported original research drugs
American Orange Book
American Orange Book
Phenylephrine Hydrochloride Eye Drops
Phenylephrine Hydrochloride Ophthalmic Solution
10%
Akorn Operating Co Llc
No imported original research drugs
American Orange Book
Phenylephrine Hydrochloride Eye Drops
Phenylephrine Hydrochloride Eye Drops
Phenylephrine Hydrochloride Ophthalmic Solution
Phenylephrine Hydrochloride Ophthalmic Solution
10%
10%
Akorn Operating Co Llc
Akorn Operating Co Llc
No imported original research drugs
No imported original research drugs
American Orange Book
American Orange Book
Orlistat Chewable Tablets
Orlistat Chewable Tablet/Alli
27mg
GlaxoSmithKline (Ireland) Limited
No imported original research drugs
EU listing
Orlistat Chewable Tablets
Orlistat Chewable Tablets
Orlistat Chewable Tablet/Alli
Orlistat Chewable Tablet/Alli
27mg
27mg
GlaxoSmithKline (Ireland) Limited
GlaxoSmithKline (Ireland) Limited
No imported original research drugs
No imported original research drugs
EU listing
EU listing
Edaravone injection
Edaravone Injection
100ml: 30mg
Mitsubishi Tanabe Pharma Corporation
Original research drugs marketed in China
Original research import
Edaravone injection
Edaravone injection
Edaravone Injection
Edaravone Injection
100ml: 30mg
100ml: 30mg
Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation
Original research drugs marketed in China
Original research drugs marketed in China
Original research import
Original research import
Avatropol maleate tablets
Avatrombopag Maleate Tablets/Doptelet (Su Kexin)
20mg
AkaRx Inc.
Original research drugs marketed in China
Original research import
Avatropol maleate tablets
Avatropol maleate tablets
Avatrombopag Maleate Tablets/Doptelet (Su Kexin)
Avatrombopag Maleate Tablets/Doptelet (Su Kexin)
20mg
20mg
AkaRx Inc.
AkaRx Inc.
Original research drugs marketed in China
Original research drugs marketed in China
Original research import
Original research import
Digoxin Tablets
Digoxin Tablets/Lanoxin
0.
125mg
125mg
Concordia Pharmaceuticals Inc
No imported original research drugs
American Orange Book
Digoxin Tablets
Digoxin Tablets
Digoxin Tablets/Lanoxin
Digoxin Tablets/Lanoxin
0.
125mg
125mg
0.
125mg
125mg
Concordia Pharmaceuticals Inc
Concordia Pharmaceuticals Inc
No imported original research drugs
No imported original research drugs
American Orange Book
American Orange Book
Olopatadine Hydrochloride Eye Drops
Olopatadine Hydrochloride ophthalmic solution 0.
2%/ Pataday
2%/ Pataday
0.
2%
2%
Alcon Laboratories Inc
No imported original research drugs
American Orange Book
Olopatadine Hydrochloride Eye Drops
Olopatadine Hydrochloride Eye Drops
Olopatadine Hydrochloride ophthalmic solution 0.
2%/ Pataday
2%/ Pataday
Olopatadine Hydrochloride ophthalmic solution 0.
2%/ Pataday
2%/ Pataday
0.
2%
2%
0.
2%
2%
Alcon Laboratories Inc
Alcon Laboratories Inc
No imported original research drugs
No imported original research drugs
American Orange Book
American Orange Book
Quetiapine Fumarate Tablets
Quetiapine Fumarate Tablets/ Seroquel
25mg
AstraZeneca Pharmaceuticals LP
No imported original research products
American Orange Book
Quetiapine Fumarate Tablets
Quetiapine Fumarate Tablets
Quetiapine Fumarate Tablets/ Seroquel
Quetiapine Fumarate Tablets/ Seroquel
25mg
25mg
AstraZeneca Pharmaceuticals LP
AstraZeneca Pharmaceuticals LP
No imported original research products
No imported original research products
American Orange Book
American Orange Book
Quetiapine Fumarate Tablets
Quetiapine Fumarate Tablets/ Seroquel
300mg
AstraZeneca Pharmaceuticals LP
No imported original research products
American Orange Book
Quetiapine Fumarate Tablets
Quetiapine Fumarate Tablets
Quetiapine Fumarate Tablets/ Seroquel
Quetiapine Fumarate Tablets/ Seroquel
300mg
300mg
AstraZeneca Pharmaceuticals LP
AstraZeneca Pharmaceuticals LP
No imported original research products
No imported original research products
American Orange Book
American Orange Book
Salmeterol ticasone inhalation powder
Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation/Advair Diskus
100mcg/50mcg
Glaxo Smith Kline
No imported original research drugs
American Orange Book
Salmeterol ticasone inhalation powder
Salmeterol ticasone inhalation powder
Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation/Advair Diskus
Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation/Advair Diskus
100mcg/50mcg
100mcg/50mcg
Glaxo Smith Kline
Glaxo Smith Kline
No imported original research drugs
No imported original research drugs
American Orange Book
American Orange Book
Salmeterol ticasone inhalation powder
Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation/Advair Diskus
250mcg/50mcg
Glaxo Smith Kline
No imported original research drugs
American Orange Book
Salmeterol ticasone inhalation powder
Salmeterol ticasone inhalation powder
Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation/Advair Diskus
Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation/Advair Diskus
250mcg/50mcg
250mcg/50mcg
Glaxo Smith Kline
Glaxo Smith Kline
No imported original research drugs
No imported original research drugs
American Orange Book
American Orange Book
Salmeterol ticasone inhalation powder
Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation/Advair Diskus
500mcg/50mcg
Glaxo Smith Kline
No imported original research drugs
American Orange Book
Salmeterol ticasone inhalation powder
Salmeterol ticasone inhalation powder
Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation/Advair Diskus
Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation/Advair Diskus
500mcg/50mcg
500mcg/50mcg
Glaxo Smith Kline
Glaxo Smith Kline
No imported original research drugs
No imported original research drugs
American Orange Book
American Orange Book
Salmeterol ticasone inhalation powder
Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation/Seretide Diskus
50mcg/100mcg
Glaxo Wellcome UK Ltd
No imported original research drugs
EU listing
Salmeterol ticasone inhalation powder
Salmeterol ticasone inhalation powder
Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation/Seretide Diskus
Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation/Seretide Diskus
50mcg/100mcg
50mcg/100mcg
Glaxo Wellcome UK Ltd
Glaxo Wellcome UK Ltd
No imported original research drugs
No imported original research drugs
EU listing
EU listing
Salmeterol ticasone inhalation powder
Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation/Seretide Diskus
50mcg/250mcg
Glaxo Wellcome UK Ltd
No imported original research drugs
EU listing
Salmeterol ticasone inhalation powder
Salmeterol ticasone inhalation powder
Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation/Seretide Diskus
Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation/Seretide Diskus
50mcg/250mcg
50mcg/250mcg
Glaxo Wellcome UK Ltd
Glaxo Wellcome UK Ltd
No imported original research drugs
No imported original research drugs
EU listing
EU listing
Salmeterol ticasone inhalation powder
Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation/Seretide Diskus
50mcg/500mcg
Glaxo Wellcome UK Ltd
No imported original research drugs
EU listing
Salmeterol ticasone inhalation powder
Salmeterol ticasone inhalation powder
Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation/Seretide Diskus
Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation/Seretide Diskus
50mcg/500mcg
50mcg/500mcg
Glaxo Wellcome UK Ltd
Glaxo Wellcome UK Ltd
No imported original research drugs
No imported original research drugs
EU listing
EU listing
Ranolazine sustained-release tablets
Ranolazine Prolonged-Release Tablets /Ranexa
500mg
Menarini International Operations Luxembourg SA
No imported original research drugs
EU listing
Ranolazine sustained-release tablets
Ranolazine sustained-release tablets
Ranolazine Prolonged-Release Tablets /Ranexa
Ranolazine Prolonged-Release Tablets /Ranexa
500mg
500mg
Menarini International Operations Luxembourg SA
Menarini International Operations Luxembourg SA
No imported original research drugs
No imported original research drugs
EU listing
EU listing
Cross-linked sodium hyaluronate injection
Hyaluronic acid, stabilized single injection/ Durolane
3 ml: Sodium Hyaluronate 60mg
Bioventus LLC
No imported original research drugs
EU listing
Cross-linked sodium hyaluronate injection
Cross-linked sodium hyaluronate injection
Hyaluronic acid, stabilized single injection/ Durolane
Hyaluronic acid, stabilized single injection/ Durolane
3 ml: Sodium Hyaluronate 60mg
3 ml: Sodium Hyaluronate 60mg
Bioventus LLC
Bioventus LLC
No imported original research drugs
No imported original research drugs
EU listing
EU listing
Teriflunomide Tablets
Teriflunomide Tablets/Aubagio
14mg
Sanofi-Aventis Groupe
No imported original research drugs
EU listing
Teriflunomide Tablets
Teriflunomide Tablets
Teriflunomide Tablets/Aubagio
Teriflunomide Tablets/Aubagio
14mg
14mg
Sanofi-Aventis Groupe
Sanofi-Aventis Groupe
No imported original research drugs
No imported original research drugs
EU listing
EU listing
Memantine Hydrochloride Tablets
Memantine Hydrochloride Tablets/Ebixa
5mg
H.
Lundbeck A/S
Lundbeck A/S
No imported original research drugs
EU listing
Memantine Hydrochloride Tablets
Memantine Hydrochloride Tablets
Memantine Hydrochloride Tablets/Ebixa
Memantine Hydrochloride Tablets/Ebixa
5mg
5mg
H.
Lundbeck A/S
Lundbeck A/S
H.
Lundbeck A/S
Lundbeck A/S
No imported original research drugs
No imported original research drugs
EU listing
EU listing
Memantine Hydrochloride Tablets
Memantine Hydrochloride Tablets/Ebixa
15mg
H.
Lundbeck A/S
Lundbeck A/S
No imported original research drugs
EU listing
Memantine Hydrochloride Tablets
Memantine Hydrochloride Tablets
Memantine Hydrochloride Tablets/Ebixa
Memantine Hydrochloride Tablets/Ebixa
15mg
15mg
H.
Lundbeck A/S
Lundbeck A/S
H.
Lundbeck A/S
Lundbeck A/S
No imported original research drugs
No imported original research drugs
EU listing
EU listing
Medium and long-chain fat emulsion/amino acid (16)/glucose (30%) injection
Medium and Long Chain Fat Emulsion / Amino Acids (16) / Glucose (30%) Injection/NuTRIflex Lipid plus
1875ml
B.
Braun Melsungen AG
Braun Melsungen AG
No imported original research drugs
EU listing
Medium and long-chain fat emulsion/amino acid (16)/glucose (30%) injection
Medium and long-chain fat emulsion/amino acid (16)/glucose (30%) injection
Medium and Long Chain Fat Emulsion / Amino Acids (16) / Glucose (30%) Injection/NuTRIflex Lipid plus
Medium and Long Chain Fat Emulsion / Amino Acids (16) / Glucose (30%) Injection/NuTRIflex Lipid plus
1875ml
1875ml
B.
Braun Melsungen AG
Braun Melsungen AG
B.
Braun Melsungen AG
Braun Melsungen AG
No imported original research drugs
No imported original research drugs
EU listing
EU listing
Fat milk amino acid (17) glucose (19%) injection
Fat Emulsion, Amino Acids (17) And Glucose (19%) Injection/Kabiven
2053ml
Fresenius Kabi
Internationally recognized drugs of the same kind
EU listing
Fat milk amino acid (17) glucose (19%) injection
Fat milk amino acid (17) glucose (19%) injection
Fat Emulsion, Amino Acids (17) And Glucose (19%) Injection/Kabiven
Fat Emulsion, Amino Acids (17) And Glucose (19%) Injection/Kabiven
2053ml
2053ml
Fresenius Kabi
Fresenius Kabi
Internationally recognized drugs of the same kind
Internationally recognized drugs of the same kind
EU listing
EU listing
Levothyroxine Sodium Tablets
Levothyroxine Sodium Tablets
200μg
Merck Serono GmbH/Merck Sante/Merck Gesellschaft mbH
No imported original research drugs
EU listing
Levothyroxine Sodium Tablets
Levothyroxine Sodium Tablets
Levothyroxine Sodium Tablets
Levothyroxine Sodium Tablets
200μg
200μg
Merck Serono GmbH/Merck Sante/Merck Gesellschaft mbH
Merck Serono GmbH/Merck Sante/Merck Gesellschaft mbH
No imported original research drugs
No imported original research drugs
EU listing
EU listing
Eplerenone tablets
Eplerenone Tablets
25mg
ファイザー Co.
, Ltd.
, Ltd.
No imported original research drugs
Listed in Japan
Eplerenone tablets
Eplerenone tablets
Eplerenone Tablets
Eplerenone Tablets
25mg
25mg
ファイザー Co.
, Ltd.
, Ltd.
ファイザー Co.
, Ltd.
, Ltd.
No imported original research drugs
No imported original research drugs
Listed in Japan
Listed in Japan
Eplerenone tablets
Eplerenone Tablets
50mg
ファイザー Co.
, Ltd.
, Ltd.
No imported original research drugs
Listed in Japan
Eplerenone tablets
Eplerenone tablets
Eplerenone Tablets
Eplerenone Tablets
50mg
50mg
ファイザー Co.
, Ltd.
, Ltd.
ファイザー Co.
, Ltd.
, Ltd.
No imported original research drugs
No imported original research drugs
Listed in Japan
Listed in Japan
Eplerenone tablets
Eplerenone Tablets
100mg
ファイザー Co.
, Ltd.
, Ltd.
No imported original research drugs
Listed in Japan
Eplerenone tablets
Eplerenone tablets
Eplerenone Tablets
Eplerenone Tablets
100mg
100mg
ファイザー Co.
, Ltd.
, Ltd.
ファイザー Co.
, Ltd.
, Ltd.
No imported original research drugs
No imported original research drugs
Listed in Japan
Listed in Japan
Tandospirone Citrate Tablets
Tandospirone Citrate Tablets
5mg
Dainippon Sumitomo Pharmaceutical Co.
, Ltd.
, Ltd.
Unimported original research
Listed in Japan
Tandospirone Citrate Tablets
Tandospirone Citrate Tablets
Tandospirone Citrate Tablets
Tandospirone Citrate Tablets
5mg
5mg
Dainippon Sumitomo Pharmaceutical Co.
, Ltd.
, Ltd.
Dainippon Sumitomo Pharmaceutical Co.
, Ltd.
, Ltd.
Unimported original research
Unimported original research
Listed in Japan
Listed in Japan
Allopurinol Tablets
Allopurinol Tablets / Zyloric
50mg
グラクソ・スミスクライン Co.
, Ltd.
, Ltd.
No imported original research drugs
Listed in Japan
Allopurinol Tablets
Allopurinol Tablets
Allopurinol Tablets / Zyloric
Allopurinol Tablets / Zyloric
50mg
50mg
グラクソ・スミスクライン Co.
, Ltd.
, Ltd.
グラクソ・スミスクライン Co.
, Ltd.
, Ltd.
No imported original research drugs
No imported original research drugs
Listed in Japan
Listed in Japan
Allopurinol Tablets
Allopurinol Tablets / Zyloric
100mg
グラクソ・スミスクライン Co.
, Ltd.
, Ltd.
No imported original research drugs
Listed in Japan
Allopurinol Tablets
Allopurinol Tablets
Allopurinol Tablets / Zyloric
Allopurinol Tablets / Zyloric
100mg
100mg
グラクソ・スミスクライン Co.
, Ltd.
, Ltd.
グラクソ・スミスクライン Co.
, Ltd.
, Ltd.
No imported original research drugs
No imported original research drugs
Listed in Japan
Listed in Japan
Perampanel tablets
Perampanel Tablets/Fycompa
2mg
Eisai Inc/
Eisai Europe Limited
No imported original research drugs
UK listed
Perampanel tablets
Perampanel tablets
Perampanel Tablets/Fycompa
Perampanel Tablets/Fycompa
2mg
2mg
Eisai Inc/
Eisai Europe Limited
Eisai Inc/
Eisai Europe Limited
No imported original research drugs
No imported original research drugs
UK listed
UK listed
Perampanel tablets
Perampanel Tablets/Fycompa
4mg
Eisai Inc/
Eisai Europe Limited
No imported original research drugs
UK listed
Perampanel tablets
Perampanel tablets
Perampanel Tablets/Fycompa
Perampanel Tablets/Fycompa
4mg
4mg
Eisai Inc/
Eisai Europe Limited
Eisai Inc/
Eisai Europe Limited
No imported original research drugs
No imported original research drugs
UK listed
UK listed
Perampanel tablets
Perampanel Tablets/Fycompa
8mg
Eisai Inc/
Eisai Europe Limited
No imported original research drugs
UK listed
Perampanel tablets
Perampanel tablets
Perampanel Tablets/Fycompa
Perampanel Tablets/Fycompa
8mg
8mg
Eisai Inc/
Eisai Europe Limited
Eisai Inc/
Eisai Europe Limited
No imported original research drugs
No imported original research drugs
UK listed
UK listed
Perampanel tablets
Perampanel Tablets/Fycompa
12mg
Eisai Inc/
Eisai Europe Limited
No imported original research drugs
UK listed
Perampanel tablets
Perampanel tablets
Perampanel Tablets/Fycompa
Perampanel Tablets/Fycompa
12mg
12mg
Eisai Inc/
Eisai Europe Limited
Eisai Inc/
Eisai Europe Limited
No imported original research drugs
No imported original research drugs
UK listed
UK listed
Morphine Sulfate/ Sustained Release Tablets
Morphine Sulphate Sustained-release Tablets
30mg
Napp Pharmaceuticals Limited
No imported original research drugs
UK listed
Morphine Sulfate/ Sustained Release Tablets
Morphine Sulfate/ Sustained Release Tablets
Morphine Sulphate Sustained-release Tablets
Morphine Sulphate Sustained-release Tablets
30mg
30mg
Napp Pharmaceuticals Limited
Napp Pharmaceuticals Limited
No imported original research drugs
No imported original research drugs
UK listed
UK listed
Lamotrigine Dispersible Tablets
Lamotrigine Dispersible Tablets/Lamictal
2mg
The Wellcome Foundation Ltd.
No imported original research drugs
UK listed
Lamotrigine Dispersible Tablets
Lamotrigine Dispersible Tablets
Lamotrigine Dispersible Tablets/Lamictal
Lamotrigine Dispersible Tablets/Lamictal
2mg
2mg
The Wellcome Foundation Ltd.
The Wellcome Foundation Ltd.
No imported original research drugs
No imported original research drugs
UK listed
UK listed
7-25
Acetaminophen tablets
Paracetamol Tablets/Panadol Advance Tablets
0.
5g
5g
GlaxoSmithKline Consumer Healthcare
EU listing
Remark 1 is revised from "European Union listing (listed country: UK; place of origin: Germany)" to "European Union listing"
7-25
7-25
Acetaminophen tablets
Acetaminophen tablets
Paracetamol Tablets/Panadol Advance Tablets
Paracetamol Tablets/Panadol Advance Tablets
0.
5g
5g
0.
5g
5g
GlaxoSmithKline Consumer Healthcare
GlaxoSmithKline Consumer Healthcare
EU listing
EU listing
Remark 1 is revised from "European Union listing (listed country: UK; place of origin: Germany)" to "European Union listing"
Remark 1 is revised from "European Union listing (listed country: UK; place of origin: Germany)" to "European Union listing"
7-88
Bromhexine Hydrochloride Tablets
Bromhexine Hydrochloride Tablets/Bisolvon
8mg
Boehringer Ingelheim Pharma GmbH & Co.
KG/Sanofi-Aventis Deutschland GmbH
KG/Sanofi-Aventis Deutschland GmbH
No imported original research drugs
The license holder changes and the license holder Sanofi-Aventis Deutschland GmbH is added
7-88
7-88
Bromhexine Hydrochloride Tablets
Bromhexine Hydrochloride Tablets
Bromhexine Hydrochloride Tablets/Bisolvon
Bromhexine Hydrochloride Tablets/Bisolvon
8mg
8mg
Boehringer Ingelheim Pharma GmbH & Co.
KG/Sanofi-Aventis Deutschland GmbH
KG/Sanofi-Aventis Deutschland GmbH
Boehringer Ingelheim Pharma GmbH & Co.
KG/Sanofi-Aventis Deutschland GmbH
KG/Sanofi-Aventis Deutschland GmbH
No imported original research drugs
No imported original research drugs
The license holder changes and the license holder Sanofi-Aventis Deutschland GmbH is added
The license holder changes and the license holder Sanofi-Aventis Deutschland GmbH is added
23-219
Fat milk amino acid (17) glucose (19%) injection
Fat Emulsion, Amino Acids (17) And Glucose (19%) Injection/Kabiven
1026ml
Fresenius Kabi AB
Internationally recognized drugs on the domestic market
The licensee is updated to Fresenius Kabi AB
23-219
23-219
Fat milk amino acid (17) glucose (19%) injection
Fat milk amino acid (17) glucose (19%) injection
Fat Emulsion, Amino Acids (17) And Glucose (19%) Injection/Kabiven
Fat Emulsion, Amino Acids (17) And Glucose (19%) Injection/Kabiven
1026ml
1026ml
Fresenius Kabi AB
Fresenius Kabi AB
Internationally recognized drugs on the domestic market
Internationally recognized drugs on the domestic market
The licensee is updated to Fresenius Kabi AB
The licensee is updated to Fresenius Kabi AB
23-220
Fat milk amino acid (17) glucose (19%) injection
Fat Emulsion, Amino Acids (17) And Glucose (19%) Injection/Kabiven
2053ml
Fresenius Kabi AB
Internationally recognized drugs on the domestic market
The licensee is updated to Fresenius Kabi AB
23-220
23-220
Fat milk amino acid (17) glucose (19%) injection
Fat milk amino acid (17) glucose (19%) injection
Fat Emulsion, Amino Acids (17) And Glucose (19%) Injection/Kabiven
Fat Emulsion, Amino Acids (17) And Glucose (19%) Injection/Kabiven
2053ml
2053ml
Fresenius Kabi AB
Fresenius Kabi AB
Internationally recognized drugs on the domestic market
Internationally recognized drugs on the domestic market
The licensee is updated to Fresenius Kabi AB
The licensee is updated to Fresenius Kabi AB
27-104
Milrinone Injection
Milrinone Injection /Primacor 1mg/ml Solution for Injection
10mg/10ml
Aventis Pharma Limited/Sanofi-Aventis/Sanofi
No imported original research drugs
Specification updated to 10mg/10ml
27-104
27-104
Milrinone Injection
Milrinone Injection
Milrinone Injection /Primacor 1mg/ml Solution for Injection
Milrinone Injection /Primacor 1mg/ml Solution for Injection
10mg/10ml
10mg/10ml
Aventis Pharma Limited/Sanofi-Aventis/Sanofi
Aventis Pharma Limited/Sanofi-Aventis/Sanofi
No imported original research drugs
No imported original research drugs
Specification updated to 10mg/10ml
Specification updated to 10mg/10ml
Remarks
1.
For products that are not on the domestic market, research needs to be carried out in accordance with the relevant requirements of the original Food and Drug Administration Announcement No.
230 in 2015.
The generic name, dosage form, etc.
shall prevail after the approval of the Pharmacopoeia Commission.
For products that are not on the domestic market, research needs to be carried out in accordance with the relevant requirements of the original Food and Drug Administration Announcement No.
230 in 2015.
The generic name, dosage form, etc.
shall prevail after the approval of the Pharmacopoeia Commission.
2.
After the publication of the reference preparation catalogue, the varieties that have not been officially released will be subject to special research and will be released separately according to the research results.
After the publication of the reference preparation catalogue, the varieties that have not been officially released will be subject to special research and will be released separately according to the research results.
3.
The reference preparations marketed in the EU include the same drugs marketed in the UK.
The reference preparations marketed in the EU include the same drugs marketed in the UK.
4.
The selection of unimported reference preparations to carry out generic drug research not only meets its quality requirements, but also needs to meet the requirements of the current version of the Chinese Pharmacopoeia and related guidelines.
The selection of unimported reference preparations to carry out generic drug research not only meets its quality requirements, but also needs to meet the requirements of the current version of the Chinese Pharmacopoeia and related guidelines.
Remarks
Remarks
1.
For products that are not on the domestic market, research needs to be carried out in accordance with the relevant requirements of the original Food and Drug Administration Announcement No.
230 in 2015.
The generic name, dosage form, etc.
shall prevail after the approval of the Pharmacopoeia Commission.
For products that are not on the domestic market, research needs to be carried out in accordance with the relevant requirements of the original Food and Drug Administration Announcement No.
230 in 2015.
The generic name, dosage form, etc.
shall prevail after the approval of the Pharmacopoeia Commission.
2.
After the publication of the reference preparation catalogue, the varieties that have not been officially released will be subject to special research and will be released separately according to the research results.
After the publication of the reference preparation catalogue, the varieties that have not been officially released will be subject to special research and will be released separately according to the research results.
3.
The reference preparations marketed in the EU include the same drugs marketed in the UK.
The reference preparations marketed in the EU include the same drugs marketed in the UK.
4.
The selection of unimported reference preparations to carry out generic drug research not only meets its quality requirements, but also needs to meet the requirements of the current version of the Chinese Pharmacopoeia and related guidelines.
The selection of unimported reference preparations to carry out generic drug research not only meets its quality requirements, but also needs to meet the requirements of the current version of the Chinese Pharmacopoeia and related guidelines.
1.
For products that are not on the domestic market, research needs to be carried out in accordance with the relevant requirements of the original Food and Drug Administration Announcement No.
230 in 2015.
The generic name, dosage form, etc.
shall prevail after the approval of the Pharmacopoeia Commission.
For products that are not on the domestic market, research needs to be carried out in accordance with the relevant requirements of the original Food and Drug Administration Announcement No.
230 in 2015.
The generic name, dosage form, etc.
shall prevail after the approval of the Pharmacopoeia Commission.
2.
After the publication of the reference preparation catalogue, the varieties that have not been officially released will be subject to special research and will be released separately according to the research results.
After the publication of the reference preparation catalogue, the varieties that have not been officially released will be subject to special research and will be released separately according to the research results.
3.
The reference preparations marketed in the EU include the same drugs marketed in the UK.
The reference preparations marketed in the EU include the same drugs marketed in the UK.
4.
The selection of unimported reference preparations to carry out generic drug research not only meets its quality requirements, but also needs to meet the requirements of the current version of the Chinese Pharmacopoeia and related guidelines.
The selection of unimported reference preparations to carry out generic drug research not only meets its quality requirements, but also needs to meet the requirements of the current version of the Chinese Pharmacopoeia and related guidelines.
National Food and Drug Administration
March 1, 2021