Announcement No. 2097 of Ministry of Agriculture of 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 and approval, the inactivated Porcine Mycoplasma pneumoniae Vaccine (PMu5722-3 strain, I) produced by Shuoteng Company was registered in China, issued the Registration Certificate of imported Veterinary drugs, and issued product quality standards, instructions and labels, which shall be implemented from the date of promulgation.

Approved the re-registration of meloxicam injection and other five veterinary drug products produced by Labiana Life Science Pharmaceutical Factory and other two companies in China, issued the Registration Certificate of imported Veterinary drugs, and issued the revised product quality standards, instructions and labels, which shall be implemented as of the date of promulgation. The previously issued quality standards for the same variety of veterinary drugs shall be abolished at the same time.

Approved the change of registration of compound nystatin ointment and other five veterinary drug products submitted by three companies, including Weilong Pharmaceutical Co., Ltd., France, and issued the revised product quality standards, instructions and labels of compound nystatin ointment and inactivated porcine mycoplasma pneumonia vaccine (Ⅱ), 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.

Attachment: 1. Registration list of imported Veterinary drugs

two。 Quality standard

3. Instructions and labels

Ministry of Agriculture

April 23, 2014

Annex 1

Registration list of imported Veterinary drugs

Name of veterinary drug

Name of production plant

Certificate number

Effective

Time limit

Remarks

Inactivated Porcine Mycoplasma pneumonia Vaccine (Pmur5722-3 strain Ⅰ)

Mycoplasma Hyopneumoniae Bacterin

Shuoteng Co., Ltd. Charlesburg production Plant in the United States

Zoetis Inc.

(2014) Foreign Veterinary Drug Certificate No. 16

2014.04

-

2019.03

Register

Meloxicam injection (20ml:400mg)

Meloxicam Injection

Labiana Life Science Pharmaceutical Factory

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

Methyl salinomycin and nicarbazine premix

Narasin and Nicarbazin Premix

American production Plant of Eli Lilly

Eli Lilly and Company

(2014) Foreign Veterinary Drug Certificate No. 21

2014.04

-

2019.03

Re-registration

Compound nystatin ointment

Compound Nystatin Ointment

France Weilong Pharmaceutical Co., Ltd.

VetoquinolFrance

(2011) Foreign Veterinary Drug Certificate No. 38

2011.11

-

2016.10

Change registration: change the validity period of veterinary drugs

Inactivated Porcine Mycoplasma pneumonia Vaccine (Pmur5722-3 strain Ⅱ)

Mycoplasma Hyopneumoniae Bacterin

American Pfizer Animal Health Company Charles Fort production Plant

PfizerAnimalHealthCharlesCity

(2009) Foreign Veterinary Drug Certificate No. 20

2009.05

-

2014.04

Change registration: the effectiveness test method was changed from serological ELISA test to in vitro ELISA test, adding the trade name Rifford.

Ceftiofur crystal injection

(for cattle) (50ml:10g)

Ceftiofur Crystalline Free Acid Injection

Shuoteng Co., Ltd. American Karamazu (Kalamazoo) production Plant

Zoetis pocket, LLC., Kalamazoo, USA

(2013) Foreign Veterinary Drug Certificate No. 58

2013.10

-

2018.09

Change registration: the name of the production enterprise has been changed from "American Pfizer" to "Shuoteng"; the name of the production plant has been changed from "Pfizer Marcia-Puqiang" to "Kalamazoo"; the address name of the production plant has been changed from "7000 Portage Road,Kalamazoo,MI 49001 USA" to "2605 E. Kilgore Rd, Kalamazoo,MI 49001 USA".

Ceftiofur crystal injection

(for cattle) (100ml:20g)

Ceftiofur Crystalline Free Acid Injection

(2013) Foreign Veterinary Drug Certificate No. 59

2013.10

-

2018.09

Attachment:

Announcement 2097.ceb

Attachment to the announcement (description and label) 2014.4.21.doc