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Announcement No. 2253 of the Ministry of Agriculture

DATE:2015-08-26       SOURCE:Bureau of Veterinary Service, MOA
 

Date of Issuance: May 4, 2015  

Issued by the Ministry of Agriculture

 

In accordance with the Regulations on Administration of Veterinary Drugs and the Measures for Registration of Veterinary Drugs, after verification, the Ministry of Agriculture approved the registration of the Blocking ELISA Test Technique for the Detection of Specific Antibodies of the gE Glycoprotein of the Aujeszky’s Disease Virus in Pig Serum and the Spinosad Chewable Tablets produced by Laboratorios HIPRA S.A. and AbbVie, Inc. respectively. The Ministry issued the Registration Certificates for Imported Veterinary Drug, together with the specifications, instructions and labels for the drugs, which will enter into force on the day of their issuance.

 

The Ministry of Agriculture approved the re-registration of the Infectious Arthritis Vaccine, Inactivated (Strain Olson WVU2937) and the Coryza Vaccine, Inactivated (Serotype A+ Serotype C) produced by two manufacturers of the Merial. The Ministry issued the Registration Certificates for Imported Veterinary Drug, together with the revised specifications, instructions and labels for the drugs, which will enter into force on the day of their issuance. The former specifications shall be abolished simultaneously.

 

The Ministry of Agriculture also approved the amended registration of two specifications of Avilamycin Premix produced by the Eli Lily and Company Limited. The Ministry issued the revised specifications, instructions and labels for the drugs, which will enter into force on the day of their issuance. The former specifications shall be abolished simultaneously.

 

The Ministry of Agriculture also approved the amended registration of Ivermectin Premix (IVOMEC®) and two specifications of Tiamulin Fumarate produced by the Dopharma B.V. and the Sandoz GmbH respectively.

 

Annex

List of Registered Imported Veterinary Drugs

  

Name

Manufacturer

Certificate No.

Validity period

Remarks

Blocking ELISA Test Technique for the Detection of Specific Antibodies of the gE Glycoprotein of the Aujeszky’s Disease Virus in Pig Serum

LABORATORIOS HIPPA, S.A

(2015)

Waishouyaozhengzi No. 24

May 2015-

April 2020

Registration

Spinosad Chewable Tablets

AbbVie, Inc.

(2015)

Waishouyaozhengzi No. 25

May 2015-

April 2020

Registration

Infectious Arthritis Vaccine, Inactivated

(Strain Olson WVU2937)

Merial Italia S.p.A

(2015)

Waishouyaozhengzi No. 26

May 2015-

April 2020

Re-registration

Coryza Vaccine, Inactivated (Serotype A+ Serotype C)

Merial S.A.SFrance

(2015)

Waishouyaozhengzi No. 27

May 2015-

April 2020

Re-registration

Avilamycin Premix (10%)

Eli Lily and Company Limited

(2014)

Waishouyaozhengzi No. 04

Feb. 2014-

Jan. 2019

Registration amendment: quality standards  

Avilamycin Premix (20%)

(2014)

 Waishouyaozhengzi No. 05

Feb. 2014-

Jan. 2019

Ivermectin Premix (IVOMEC®) (0.6%)

Dopharma B.V.

(2011)

Waishouyaozhengzi No. 32

Aug. 2011-

July 2016

Registration amendment: Validity was changed to three years.

Tiamulin Fumarate Soluble Power (45%)

Sandoz GmbH

(2011)

 Waishouyaozhengzi No. 11

May 2011-

April 2016

Registration amendment: change of manufacturer name from the Sandoz Plant, Novartis International Ag to Sandoz GmbH

Tiamulin Fumarate Premix (80%)

Sandoz GmbH

(2011)

Waishouyaozhengzi No. 12

May 2011-

April 2016

 

 

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