The Ministry of Agriculture of the People's Republic of China issues Announcement No. 2097
In accordance with the provisions of the Regulations on the Administration of Veterinary Drugs and the Measures for the Registration of Veterinary Drugs, upon review, the inactivated vaccine against Mycoplasma hyopneumoniae (strain P-5722-3, I) produced by Zoetis has been approved for registration in China, the Imported Veterinary Drug Registration Certificate has been issued, and the product quality standards, instructions and labels have been published, effective from the date of publication.
The re-registration in China of 5 veterinary drug products, including Meloxicam Injection, produced by 2 companies such as Labiana Life Science S.A., has been approved, the Imported Veterinary Drug Registration Certificate has been issued, and the revised product quality standards, instructions and labels have been published, effective from the date of publication. The quality standards for veterinary drug products of the same variety previously published are simultaneously repealed.
⟦NL> The changes in registration in China of 5 veterinary drug products, including Compound Nystatin Ointment, submitted by 3 companies such as Vetoquinol France, have been approved, and the revised product quality standards, instructions and labels for Compound Nystatin Ointment and the inactivated vaccine against Mycoplasma hyopneumoniae (strain P-5722-3, II) have been published, effective from the date of publication. The quality standards for veterinary drug products of the same variety previously published are simultaneously repealed.
Attachments: 1. Imported Veterinary Drug Registration Directory
2. Quality Standards
3. Instructions and Labels
Ministry of Agriculture
April 23, 2014
Attachment 1
Imported Veterinary Drug Registration Directory
|
Veterinary Drug Name |
Manufacturer Name |
Certificate No. |
Valid Period |
Remarks |
|
Inactivated Vaccine against Mycoplasma hyopneumoniae (strain P-5722-3, I) Mycoplasma Hyopneumoniae Bacterin |
Zoetis Inc. Charles City Production Plant, USA Zoetis Inc. |
(2014) Foreign Veterinary Drug Certificate No. 16 |
2014.04 - 2019.03 |
Registration |
|
Meloxicam Injection (20ml:400mg) Meloxicam Injection |
Labiana Life Science S.A. Labiana Life Science S.A. |
(2014) Foreign Veterinary Drug Certificate No. 17 |
2014.04 - 2019.03 |
Re-registration |
|
Meloxicam Injection (50ml:1g) Meloxicam Injection |
(2014) Foreign Veterinary Drug Certificate No. 18 |
|||
|
Meloxicam Injection (100ml:2g) Meloxicam Injection |
(2014) Foreign Veterinary Drug Certificate No. 19 |
|||
|
Meloxicam Injection (250ml:5g) Meloxicam Injection |
(2014) Foreign Veterinary Drug Certificate No. 20 |
|||
|
Narasin and Nicarbazin Premix Narasin and Nicarbazin Premix |
Eli Lilly and Company US Production Plant Eli Lilly and Company |
(2014) Foreign Veterinary Drug Certificate No. 21 |
2014.04 - 2019.03 |
Re-registration |
|
Compound Nystatin Ointment Compound Nystatin Ointment |
Vetoquinol France VetoquinolFrance |
(2011) Foreign Veterinary Drug Certificate No. 38 |
2011.11 - 2016.10 |
Change of registration: change of veterinary drug validity period |
|
Inactivated Vaccine against Mycoplasma hyopneumoniae (strain P-5722-3, II) Mycoplasma Hyopneumoniae Bacterin |
Pfizer Animal Health Charles City Production Plant, USA PfizerAnimalHealthCharlesCity |
(2009) Foreign Veterinary Drug Certificate No. 20 |
2009.05 - 2014.04 |
Change of registration: the potency test method is changed from serological ELISA assay to in vitro ELISA assay, and the trade name RespiSure is added |
|
Ceftiofur Crystalline Free Acid Injection (for cattle) (50ml:10g) Ceftiofur Crystalline Free Acid Injection |
Zoetis P&U, LLC., Kalamazoo Production Plant, USA Zoetis P&U, LLC., Kalamazoo, USA |
(2013) Foreign Veterinary Drug Certificate No. 58 |
2013.10 - 2018.09 |
Change of registration: the manufacturing company name is changed from “Pfizer Inc. USA” to “Zoetis”; the production plant name is changed from “Pfizer Pharmaceuticals - Upjohn Company, USA” to “Zoetis P&U, LLC., Kalamazoo Production Plant, USA”; the production plant address is changed from “7000 Portage Road, Kalamazoo, MI 49001, USA” to “2605 E. Kilgore Rd, Kalamazoo, MI 49001, USA” |
|
Ceftiofur Crystalline Free Acid Injection (for cattle) (100ml:20g) Ceftiofur Crystalline Free Acid Injection |
(2013) Foreign Veterinary Drug Certificate No. 59 |
2013.10 - 2018.09 |
Attachments: