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The State Food and Drug Administration cancelled 78 drug registration certificates such as curcum oil glucose injection

 Last Update: 2023-01-01
 Source: Internet
 Author: User

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In accordance with the relevant provisions of the Regulations for the Implementation of the Drug Administration Law of the People's Republic of China and the Measures for the Administration of Drug Registration, the State Medical Products Administration decided to cancel 78 drug registration certificates
such as curcum oil glucose injection.
This is hereby announced
.
Attachment: Cancellation of the catalogue of drug registration certificates

serial number	Generic name of the drug	Approval number	dosage form	specification	Drug MAH holders	Logout scenarios
1	Curcum oil glucose injection	H20044181	injection	250ml: 0. 1 g of curcum oil with 12. 5 g of glucose	Inner Mongolia Baiyi Pharmaceutical Co. , Ltd	Cancel upon application
2	oxygen	H20045924	gas	40L	Hohhot Railway Oxygen Plant	Cancel upon application
3	Betaxine hydrochloride sodium chloride injection	Sinopharm H15021430	injection	500 ml: betaglustatine hydrochloride 0. 02 g, sodium chloride 4. 5 g	Inner Mongolia Baiyi Pharmaceutical Co. , Ltd	Cancel upon application
4	Troxerutin sodium chloride injection	H20059525	injection	100 ml: troxerutin 0. 4 g with sodium chloride 0. 9 g	Inner Mongolia Baiyi Pharmaceutical Co. , Ltd	Cancel upon application
5	Eighteen flavored koji pills	Sinopharm Z20027806	Pills	Each pill weighs 0. 5g (Tibetan medicine) Every 10 pills weigh 2g (Mongolian medicine)	Inner Mongolia Kulunmeng Pharmaceutical Co. , Ltd	Cancel upon application
6	Cefoperazone sodium for injection, sulbactam sodium	H20057403	injection	0. 75g (with cefoperazone 0. 5g and sulbactam 0. 25g)	Pfizer Pharmaceuticals Limited	Cancel upon application
7	Cefoperazone sodium for injection, sulbactam sodium	H20020598	injection	3. 0g (C25H27N9O8S2 2. 0g and C8H11NO5S 1. 0g)	Pfizer Pharmaceuticals Limited	Cancel upon application
8	Pidotimod capsules	H20090359	Capsules	0. 4g	Nanjing Haichen Pharmaceutical Co. , Ltd	Cancel upon application
9	Metronidazole sodium chloride injection	H34021677	injection	250 ml: metronidazole 0. 5 g with sodium chloride 2. 25 g	Anhui Fubang Pharmaceutical Co. , Ltd	Cancel upon application
10	Glycerol fructose sodium chloride injection	H20057114	injection	250ml: glycerol 25g, fructose 12. 5g, sodium chloride 2. 25g	Chenxin Pharmaceutical Co. , Ltd	Cancel upon application
11	Matanthin dispersible tablets	H20080045	Tablets	0. 1g (calculated as C15H24N2O2)	Yichang East Sunshine Changjiang Pharmaceutical Co. , Ltd	Cancel upon application
12	Amfe chips	H64020255	Tablets	Each tablet contains aminopyrine 100mg, phenacetin 150mg and coffee 45mg	Ningxia Qiyuan Sinopharm Co. , Ltd	Cancel upon application
13	Povidone-iodine solution	H62020419	Solution	100ml:7. 5g	Jinchang Jindan Pharmaceutical Co. , Ltd	No re-registration
14	Povidone-iodine solution	H62020420	Solution	100ml:5g	Jinchang Jindan Pharmaceutical Co. , Ltd	No re-registration
15	Povidone-iodine solution	H62020435	Solution	100ml:10g	Jinchang Jindan Pharmaceutical Co. , Ltd	No re-registration
16	Povidone-iodine solution	H62021266	Solution	1%	Jinchang Jindan Pharmaceutical Co. , Ltd	No re-registration
17	Hepatitis C Virus Antibody Diagnostic Kit (ELISA)	Sinopharm S19980199	In vitro diagnostic reagents	Serves 48	Lanzhou Biaojia Biotechnology Co. , Ltd	No re-registration
18	Hepatitis B Viral Surface Antigen Diagnostic Kit (ELISA)	Sinopharm S19980088	In vitro diagnostic reagents	Serves 96	Lanzhou Biaojia Biotechnology Co. , Ltd	No re-registration
19	Hepatitis B Viral Surface Antigen Diagnostic Kit	Sinopharm S19980091	In vitro diagnostic reagents	Serves 48	Lanzhou Biaojia Biotechnology Co. , Ltd	No re-registration
20	Hepatitis C virus antibody diagnostic kit	Sinopharm S19980084	In vitro diagnostic reagents	Serves 96	Lanzhou Biaojia Biotechnology Co. , Ltd	No re-registration
21	Y. pestis diagnostic serum	Sinopharm S10820132	In vitro diagnostic reagents	2ml	Lanzhou Institute of Biological Products	No re-registration
22	Y. pestis F1 antibody diagnostic reagent (hemagglutination)	Sinopharm S10820129	In vitro diagnostic reagents	1ml	Lanzhou Institute of Biological Products	No re-registration
23	Hepatitis B virus e antigen diagnostic kit (enzyme-linked immunoassay)	Sinopharm S10910036	Diagnostic kits	48 servings/box	Lanzhou Institute of Biological Products	No re-registration
24	BCG pure protein derivatives	Sinopharm S10940023	In vivo diagnostic reagents	50IU/ml	Lanzhou Institute of Biological Products	No re-registration
25	Hepatitis B virus core antibody diagnostic kit (enzyme-linked immunoassay)	Sinopharm S10910042	Diagnostic kits	96 servings/box	Lanzhou Institute of Biological Products	No re-registration
26	Hepatitis B virus surface antibody diagnostic kit (enzyme-linked immunoassay)	Sinopharm S10910039	Diagnostic kits	96 servings/box	Lanzhou Institute of Biological Products	No re-registration
27	Sikh test toxin	Sinopharm S10820134	In vitro diagnostic reagents	Serves 10	Lanzhou Institute of Biological Products	No re-registration
28	Rotavirus diagnostic kit	Sinopharm S10870016	Diagnostic kits	Serves 48	Lanzhou Institute of Biological Products	No re-registration
29	Hepatitis B virus e antigen diagnostic kit (enzyme-linked immunoassay)	Sinopharm S10910037	Diagnostic kits	96 servings/box	Lanzhou Institute of Biological Products	No re-registration
30	Hepatitis B virus E antibody diagnostic kit (enzyme-linked immunoassay)	Sinopharm S10910035	Diagnostic kits	96 servings/box	Lanzhou Institute of Biological Products	No re-registration
31	Hepatitis B virus core antibody diagnostic kit (enzyme-linked immunoassay)	Sinopharm S10910043	Diagnostic kits	48 servings/box	Lanzhou Institute of Biological Products	No re-registration
32	Hepatitis B virus E antibody diagnostic kit (enzyme-linked immunoassay)	Sinopharm S10910044	Diagnostic kits	48 servings/box	Lanzhou Institute of Biological Products	No re-registration
33	Hepatitis B virus surface antibody diagnostic kit (enzyme-linked immunoassay)	Sinopharm S10910038	Diagnostic kits	48 servings/box	Lanzhou Institute of Biological Products	No re-registration
34	Neisseria meningitidis diagnostic serum	Sinopharm S10820076	In vitro diagnostic reagents	1ml	Lanzhou Institute of Biological Products	No re-registration
35	Small septic paste	Sinopharm Z12020164	Decoction (ointment)	60g per bottle; 120g per bottle; 180g per bottle; 10g per bag; 15g per bag	Tianjin Boai Biopharmaceutical Co. , Ltd	Revoked in accordance with the law
36	St. John's wort (Hypericum perforatum) extract	Z20120001	APIs	50kg per barrel	Dr. Willmar Schwabe GmbH & Co. KG	Cancel upon application
37	Hepatitis C Virus Antibody Diagnostic Kit (ELISA)	S20140098	Diagnostic kits	96 servings/box	DiaSorin South Africa (Proprietary) Limited	Cancel upon application
38	Love Choleton softgels	Z20201000	Capsules	0. 2g per capsule (equivalent to 0. 2g of Ou Huo Blood Dan)	Pharmazeutische Fabrik Evers GmbH & Co. KG	Cancel upon application
39	Letrozole tablets	Sinopharm HJ20200030	Tablets	2. 5mg	Fresenius Kabi oncology Limited	Cancel upon application
40	Bicalutamide tablets	H20190033	Tablets	50mg	Fresenius Kabi oncology Limited	Cancel upon application
41	Azithromycin for injection	H20160579	injection	0. 5g (500,000)	Pliva Croatia Ltd.	Cancel upon application
42	Natamycin eye drops	H20171229	Eye drops	15ml:0. 75g	Novartis pharmaceuticals Corporation	Cancel upon application
43	Edaravone injection	H20190045	injection	100ml:30mg	Mitsubishi Tanabe Pharma Corporation	Cancel upon application
44	Edaravone injection	H20201002	injection	100ml:30mg	Mitsubishi Tanabe Pharma Corporation	Cancel upon application
45	Edaravone injection	Sinopharm J20200009	injection	100ml:30mg	Mitsubishi Tanabe Pharma Corporation	Cancel upon application
46	Bivalent human papillomavirus adsorbed vaccine	Sinopharm SJ20160026	injection	0. 5ml/bottle (containing HPV-16 L1 protein and HPV-18 L1 protein 20μg each)	GlaxoSmithKline Biologicals S. A.	Cancel upon application
47	Bivalent human papillomavirus adsorbed vaccine	Sinopharm SJ20160027	injection	0. 5ml/bottle (containing HPV-16 L1 protein and HPV-18 L1 protein 20μg each)	GlaxoSmithKline Biologicals S. A.	Cancel upon application
48	Inocoagulin α for injection	Sinopharm SJ20210009	injection	250IU/bottle	Bioverativ Therapeutics, Inc	Cancel upon application
49	Inocoagulin α for injection	Sinopharm SJ20210010	injection	500IU/bottle	Bioverativ Therapeutics, Inc	Cancel upon application
50	Inocoagulin α for injection	Sinopharm SJ20210011	injection	1000IU/bottle	Bioverativ Therapeutics, Inc	Cancel upon application
51	Inocoagulin α for injection	Sinopharm SJ20210012	injection	2000IU/bottle	Bioverativ Therapeutics, Inc	Cancel upon application
52	Enteral nutrition emulsion (TPF-T)	H20130820	Oral emulsion	500ml/bag (neutral flavor)	Fresenius Kabi Deutschland GmbH	Cancel upon application
53	Enteral nutrition emulsion (TPF-T)	H20130819	Oral emulsion	500ml/bag (neutral flavor)	Fresenius Kabi Deutschland GmbH	Cancel upon application
54	Enteral nutrition emulsion (TPF-T)	Sinopharm J20130177	Oral emulsion	500ml/bag (neutral flavor)	Fresenius Kabi Deutschland GmbH	Cancel upon application
55	Enteral nutrition emulsion (TPF-D)	H20140189	Oral emulsion	500ml/bottle	Fresenius Kabi Deutschland GmbH	Cancel upon application
56	Enteral nutrition emulsion (TPF-D)	H20140190	Oral emulsion	500ml/bottle	Fresenius Kabi Deutschland GmbH	Cancel upon application
57	Enteral nutrition emulsion (TPF-D)	Sinopharm J20140078	Oral emulsion	500ml/bottle	Fresenius Kabi Deutschland GmbH	Cancel upon application
58	Enteral nutrition emulsion (TPF-D)	H20140192	Oral emulsion	500ml/bottle	Fresenius Kabi Deutschland GmbH	Cancel upon application
59	Enteral nutrition emulsion (TPF-D)	H20140191	Oral emulsion	500ml/bottle	Fresenius Kabi Deutschland GmbH	Cancel upon application
60	Enteral nutrition emulsion (TPF-D)	Sinopharm J20140077	Oral emulsion	500ml/bottle	Fresenius Kabi Deutschland GmbH	Cancel upon application
61	Enteral nutrition emulsion (TPF-D)	H20140193	Oral emulsion	1000ml/bottle	Fresenius Kabi Deutschland GmbH	Cancel upon application
62	Enteral nutrition emulsion (TPF-D)	H20140194	Oral emulsion	1000ml/bottle	Fresenius Kabi Deutschland GmbH	Cancel upon application
63	Enteral nutrition emulsion (TPF-D)	Sinopharm J20140112	Oral emulsion	1000ml/bottle	Fresenius Kabi Deutschland GmbH	Cancel upon application
64	Enteral nutrition emulsion (TP)	H20140223	Oral emulsion	500ml/bag	Fresenius Kabi Deutschland GmbH	Cancel upon application
65	Enteral nutrition emulsion (TP)	H20140255	Oral emulsion	500ml/bag	Fresenius Kabi Deutschland GmbH	Cancel upon application
66	Enteral nutrition emulsion (TP)	Sinopharm J20140075	Oral emulsion	500ml/bag	Fresenius Kabi Deutschland GmbH	Cancel upon application
67	Enteral nutrition emulsion (TP-HE)	H20130845	Oral emulsion	500ml/bag	Fresenius Kabi Deutschland GmbH	Cancel upon application
68	Enteral nutrition emulsion (TP-HE)	H20130846	Oral emulsion	500ml/bag	Fresenius Kabi Deutschland GmbH	Cancel upon application
69	Enteral nutrition emulsion (TP-HE)	Sinopharm J20130178	Oral emulsion	500ml/bag	Fresenius Kabi Deutschland GmbH	Cancel upon application
70	Asimethin sustained-release capsules	H20130600	Capsules	90mg	Mylan Healthcare GmbH	Cancel upon application
71	Alverin citrate capsules	H20140183	Capsules	60mg	Mylan Products Limited	Cancel upon application
72	Vitamin C effervescent tablets	Sinopharm HJ20140845	Tablets	1000mg	Bayer(Schweiz)AG	Cancel upon application
73	Strontium chloride [89Sr] injection	H20140617	injection	150MBq(4mCi)/4mL	GE HEALTHCARE LIMITED	Cancel upon application
74	Lornoxicam for injection	H20150236	injection	8mg (8. 6mg per bottle)	Takeda Austria GmbH	Cancel upon application
75	Metformin vildagliptin tablets (III. )	Sinopharm HJ20171035	Tablets	Each tablet contains metformin hydrochloride 1000mg and vildagliptin 50mg	Novartis Pharma Schweiz AG	Cancel upon application
76	Bicalutamide tablets	Sinopharm HJ20200061	Tablets	50mg	Sun Pharmaceutical Industries Limited	Cancel upon application
77	Ondansetron hydrochloride injection	H20170314	injection	2ml:4mg	Novartis Pharma Schweiz AG	Cancel upon application
78	Ondansetron hydrochloride injection	H20170315	injection	4ml:8mg	Novartis Pharma Schweiz AG	Cancel upon application

State Food and Drug Administration November 22, 2022

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