Date of Issuance: January 8, 2013
Issued by Ministry of Agriculture
In accordance with the Regulations on Administration of Veterinary Drugs and Measures for the Registration of Veterinary Drugs, after verification, the Ministry of Agriculture has approved the registration of Swine Mycoplasma Hyopneumoniae Vaccine,Inactivated(Strain J)produced by Boehringer Ingelheim Vetmedica, Inc. and Live Vaccine against Canine Distemper, Adenovirus Type 2, Parvovirosis, Parainfluenza Virus and Inactivated Vaccine Against Canine Leptospirosis (Canicola+ Icterohaemorrhagiae) produced by Laboratorios HIPRA S.A.in China. Along with these registrations, the Ministry has also approved the registration renewal of Fowl Laryngotracheitis Vaccine,Modified Live Virus(Strain Salsbury #146)and other 2 veterinary drugs produced by 3 foreign companies including Pfizer Animal Health. The Ministry has issued the Registration Certificate for Import Veterinary Drugs, together with the revised specifications, instructions and labels for these drugs, which will enter into force on the day of their issuance. The former specifications shall be abolished simultaneously.
Two errors were found in the Annex of MOA Announcement No.1830 about Oxytetracycline Long Acting Injection produced by Pfizer Animal Health. They are corrected in the Annex of this Announcement.
Annex
List of Registered Imported Veterinary Drugs
|
Name |
Manufacturer |
Certificate No. |
Validity period |
Remarks |
|
Swine Mycoplasma Hyopneumoniae Vaccine,Inactivated(Strain J) |
Boehringer Ingelheim Vetmedica, Inc. |
No.1 of 2013 of Foreign Veterinary Certificate |
2013.01 - 2017.12 |
Registration |
|
Live Vaccine against Canine Distemper, Adenovirus Type 2, Parvovirosis, Parainfluenza Virus and Inactivated Vaccine Against Canine Leptospirosis (Canicola+ Icterohaemorrhagiae) |
Laboratorios HIPRA S.A. |
No.2 of 2013 of Foreign Veterinary Certificate |
2013.01 - 2017.12 |
Registration |
|
Fowl Laryngotracheitis Vaccine,Modified Live Virus(Strain Salsbury #146) |
Pfizer Animal Health |
No.3 of 2013 of Foreign Veterinary Certificate |
2013.01 - 2017.12 |
Registration renewal |
|
Newcastle Disease, Infectious Bronchitis and Egg Drop Syndrome Vaccine,Inactivated(StrainLa Sota+Strain M41+Strain B8/78) |
CEVA-PHYLAXIA Veterinary Biological Co.Ltd |
No.4 of 2013 of Foreign Veterinary Certificate |
2013.01 - 2017.12 |
Registration renewal |
|
Salmonella Enteritidis Vaccine,Live (Strain Sm24/Rif12/Ssq ) |
Lohmann Animal Health GmbH & Co. KG |
No.5 of 2013 of Foreign Veterinary Certificate |
2013.01 - 2017.12 |
Registration renewal |
|
Oxytetracycline Long Acting Injection(20ml:4g) |
Laboratorios Pfizer LTDA. |
No.52 of 2012 of Foreign Veterinary Certificate |
2012.09 - 2017.08 |
The product concentration is “20ml:4g(4 million units)” instead of “20ml: 2g (2 million units)” |
|
Oxytetracycline Long Acting Injection(250ml:50g) |
Laboratorios Pfizer LTDA. |
No.52 of 2012 of Foreign Veterinary Certificate |
2012.09 - 2017.08 |
The product concentration is “250ml:50g(50 million units)” instead of “250ml: 25g (25 million units)” |