Date of Issuance: August 30, 2013
Issued by Ministry of Agriculture
In accordance with the Administrative Regulations on Veterinary Drugs and Measures for the Registration of Veterinary Drugs, after verification, the Ministry of Agriculture approved the registration of Fipronil Methoprene and Amitraz Spot On Solutions and other 3 drugs produced by MERIALToulouse and Haupt Pharma Latina s.r.l. The Ministry issued the Registration Certificate for Imported Veterinary Drugs, together with the specifications, instructions and labels for the above-mentioned products, which will enter into force upon issuance.
The Ministry of Agriculture approved the re-registration of Rabies Vaccine, Killed Virus (Strain HCP-SAD) produced by Boehringer Ingelheim Vetmedical, Inc. . The Ministry issued the Registration Certificate for Imported Veterinary Drugs, together with the revised specifications, instructions and labels for the above-mentioned product, which will enter into force upon issuance. The former specifications shall be abolished simultaneously.
The Ministry of Agriculture approved the amended registration ofBordetella Bronchiseptica-Pasteurella Multocida Bacterin-Toxid produced by Division of Pfizer Inc. in China. The Ministry issued the amended specifications, instructions and labels for the above-mentioned product, which will enter into force upon issuance. The former specifications shall be abolished simultaneously.
The Ministry of Agriculture approved the amended registration ofInfectious Bursal Disease Vaccine，Live（Strain D22）produced by P.T. Medion.
Annex
List of Registered Imported Veterinary Drugs
|
Name |
Manufacturer |
Certificate No. |
Validity period |
Remarks |
|
Fipronil Methoprene and Amitraz Spot On Solutions |
MERIALToulouse |
No.45 of 2013 of Certificate for Imported Veterinary Drugs |
2013.08 - 2018.07 |
Registration |
|
Amoxicillin and Clavulanate Potassium Tablets(50mg) |
Haupt Pharma Latina s.r.l |
No.46 of 2013 of Certificate for Imported Veterinary Drugs |
2013.08 - 2018.07 |
Registration |
|
Amoxicillin and Clavulanate Potassium Tablets(250mg) |
Haupt Pharma Latina s.r.l |
No.47 of 2013 of Certificate for Imported Veterinary Drugs |
2013.08 - 2018.07 |
Registration |
|
Amoxicillin and Clavulanate Potassium Tablets(500mg) |
Haupt Pharma Latina s.r.l |
No.48 of 2013 of Certificate for Imported Veterinary Drugs |
2013.08 - 2018.07 |
Registration |
|
Rabies Vaccine, Killed Virus（Strain HCP-SAD） |
Boehringer Ingelheim Vetmedical, Inc. |
No.49 of 2013 of Certificate for Imported Veterinary Drugs |
2013.08 - 2018.07 |
Re-registration |
|
Bordetella Bronchiseptica-Pasteurella Multocida Bacterin-Toxid |
Division of Pfizer Inc. |
No.43 of 2013 of Certificate for Imported Veterinary Drugs |
2013.08 - 2018.07 |
Amended registration: the temperature and evaluation for vaccine potency test in the Chinese version of specifications annex were amended; the English name of the vaccine is changed to “Bordetella Bronchiseptica-Pasteurella Multocida Bacterin-Toxoid”; the packaging details are changed to: ”30 bottles/box for 1 head; 10 bottles/box for 5 heads; 100 bottles/trunk for 10 heads; and 100 bottles/trunk for 50 heads”1; and the registrant is changed to “Zoetis Animal Health Co., Ltd., Shanghai”. |
|
Infectious Bursal Disease Vaccine，Live（Strain D22） |
P.T. Medion |
No.44 of 2012 of Certificate for Imported Veterinary Drugs |
2012.08 - 2017.07 |
Amended registration: “2000 doses/vial” was added to the packaging details. |
Note:
1. The description in the quotation marks are translated from the Chinese version, and is for reference only.
No.11 Nongzhanguan Nanli,Chaoyang District,Beijing China (100125)
