Notice No. 2117 of the Ministry of Agriculture of the people's Republic of China
According to the regulations on the Administration of Veterinary drugs and the measures for the Registration of Veterinary drugs, after examination, it is approved that the live recombinant fowlpox virus vaccine of infectious laryngotracheitis produced by Shihua American Baimiao Animal Health Co., Ltd. shall be registered in China, issue the Registration Certificate of imported Veterinary drugs, and issue product quality standards, instructions and labels, which shall be implemented from the date of promulgation.
Approved the re-registration of six kinds of veterinary drug products such as tylosin tartrate soluble powder produced by four companies, including the British production plant of Lilly Company of the United States, issued the Certificate of Registration of imported Veterinary drugs, and issued the revised product quality standards, instructions and labels, which shall be implemented from the date of promulgation. The previously issued quality standards for the same variety of veterinary drugs shall be abolished at the same time.
Approve the change and registration of enrofloxacin injection and other two kinds of veterinary drug products produced by KVP Kiel Co., Ltd., and issue revised product quality standards, instructions and labels, which shall be implemented from the date of release. The previously issued quality standards for the same variety of veterinary drugs shall be abolished at the same time.
Ten kinds of veterinary drug products, including canine distemper, adenovirus type 2, parainfluenza and parvovirus disease quadruple live vaccines produced by Shuoteng and other two companies have been approved to be registered in China.
It is hereby announced.
Attachment: 1. Registration list of imported Veterinary drugs
two。 Quality standard
3. Instructions and labels
Ministry of Agriculture
June 24, 2014
Annex 1
Registration list of imported Veterinary drugs
Name of veterinary drug
Name of production plant
Certificate number
Effective
Time limit
Remarks
Live Recombinant Fowlpox virus Vaccine against Infectious Laryngotracheitis
Fowl Pox-Laryngotracheitis Vaccine,Live Fowl Pox Vector
Shihua American Baimiao Animal Health Co., Ltd.
Biomune Company
(2014) Foreign Veterinary Drug Certificate No. 22
2014.06
-
2019.05
Register
Tylosin tartrate soluble powder
Tylosin Tartrate Soluble Powder
American Eli Lilly UK production Plant
Eli Lilly and Company Limited
(2014) Foreign Veterinary Drug Certificate No. 23
2014.06
-
2019.05
Re-registration
Enrofloxacin
Enrofloxacin
KVP Kiel Co., Ltd.
KVP Pharma + Veterin ä r Produkte GmbH
(2014) Foreign Veterinary Drug Certificate No. 24
2014.06
-
2019.05
Re-registration
Tuoqu Zhu Li
Toltrazuril
(2014) Foreign Veterinary Drug Certificate No. 25
Amoxicillin soluble powder
Amoxicillin Soluble Powder
Interway International Co., Ltd. Italian production Plant
Intervet Productions S.r.l.
(2014) Foreign Veterinary Drug Certificate No. 26
2014.06
-
2019.05
Re-registration
Porcine circovirus type 2 baculovirus vector inactivated vaccine
Porcine Circovirus Type 2 Baculovirus Vector Vaccine,Inactivated
Boehringer Ingelheim Animal Health (USA) Co., Ltd.
Boehringer Ingelheim Vetmedica,Inc.
(2014) Foreign Veterinary Drug Certificate No. 27
2014.06
-
2019.05
Re-registration
Live porcine reproductive and respiratory syndrome vaccine
Porcine Reproductive and Respiratory Syndrome Vaccine,Live
(2014) Foreign Veterinary Drug Certificate No. 28
2014.06
-
2019.05
Re-registration
Enrofloxacin injection
(100ml:10g)
Enrofloxacin Injection
KVP Kiel Co., Ltd.
KVP Pharma+Veterinar Produkte GmbH
(2010) Foreign Veterinary Drug Certificate No. 17
2010.04
-
2015.03
Change of registration: increase the use of bacteria and mycoplasma infections in cattle
Blood gonadotropin, chorionic gonadotropin for injection
Serum Gonadotrophin and Chorionic Gonadotrophin for Injection
Interway international Ltd.
Intervet International B.V.
(2011) Foreign Veterinary Drug Certificate No. 17
2011.05
-
2016.04
Change of registration: change of storage conditions of veterinary drugs
Inactivated porcine atrophic rhinitis vaccine
Bordeiella Bronchiseptica-Pasteurella Multocida Bacterin-Toxoid
Shuoteng Co., Ltd. American Lincoln (Lincoln) production Plant
Zoetis Inc.,Lincoln,USA
(2013) Foreign Veterinary Drug Certificate No. 43
2013.08
-
2018.07
Change registration: the name of the production enterprise has been changed from "Pfizer Inc." to "Zoetis Inc."; the name of the production plant has been changed from "Pfizer Lincoln production Plant" to "Lincoln production Plant".
Porcine pseudorabies live vaccine (Bucharest strain)
Pseudorabies Vaccine,Modified Live Virus
(2013) Foreign Veterinary Drug Certificate No. 44
2013.08
-
2018.07
Live quadruple vaccine against canine distemper, adenovirus 2, parainfluenza and parvovirus disease
Canine Distemper,Adenovirus Type2,Parainfluenza and Parvovirus Vaccine,Modified Live Virus
(2012) Foreign Veterinary Drug Certificate No. 03
2012.01
-
2016.12
Live canine parvovirus vaccine
Parvovirus Vaccine,Modified Live Virus
(2011) Foreign Veterinary Drug Certificate No. 10
2011.04
-
2016.03
Four live vaccines of canine distemper, adenovirus type 2, parainfluenza and parvovirus disease-canine leptospirosis (canine type, jaundice hemorrhagic type) bivalent inactivated vaccine-canine coronavirus inactivated vaccine
Canine Distemper-Adenovirus Type2-Coronavirus-Parainfluenza-Parvovirus Vaccine,Modified Live and Killed Virus,Leptospira Canicola-Icterohaemorrhagiae Bacterin
(2011) Foreign Veterinary Drug Certificate No. 18
2011.05
-
2016.04
Inactivated vaccine against type C clostridium perfringens and colibacillosis in piglets
Clostridium Perfringens Type C and Escherichia Coli Vaccine,Inactivated
(2013) Foreign Veterinary Drug Certificate No. 33
2013.05
-
2018.04
Chicken Marek's disease turkey herpesvirus frozen live vaccine (FC-126 strain)
Marek's Disease Vaccine,Live (HVT FC-126 Strain)
Meria Co., Ltd. (USA)
Merial, Inc.
(2013) Foreign Veterinary Drug Certificate No. 69
2013.12
-
2018.11
Change registration: the name of the production enterprise is changed to
"Merial, Inc."; change the registered address to "1730 Olympic Drive Athens, GA30601"
Live Marek's disease turkey herpesvirus vaccine (FC126 strain)
Marek's Disease Turkey Herpesvirus Vaccine,Live (Strain FC126)
(2011) Foreign Veterinary Drug Certificate No. 02
2011.01
-
2015.12
Live chicken Marek's disease vaccine (CVI1988 strain)
Marek's Disease Vaccine,Live (Strain CVI1988)
(2011) Foreign Veterinary Drug Certificate No. 03
2011.02
-
2016.01
Bivalent live vaccine of Ⅰ and Ⅲ types of Marek's disease in chickens
Marek's Disease (Serotype Ⅰ, Ⅲ) Bivalent Vaccine,Live
(2012) Foreign Veterinary Drug Certificate No. 09
2012.02
-
2017.01
Attachment:
Ministry of Agriculture Bulletin No. 2117. CEB
Attachment to the announcement (manual and label). Doc
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