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中华人民共和国农业农村部公告 第122号 Announcement No. 122 of the Ministry of Agriculture and Rural Affairs

DATE:2019-01-22       SOURCE:MARA
 
  根据《兽药管理条例》和《兽药注册办法》规定,经审查,批准法国维克有限公司等3家公司生产的头孢氨苄片等3种兽药产品在我国再注册,核发《进口兽药注册证书》,并发布修订后的产品质量标准、说明书和标签,自发布之日起执行。此前发布的该产品兽药质量标准、说明书和标签同时废止。 

特此公告。 

附件:1.进口兽药注册目录 

           2.质量标准 

           3.说明书和标签  

农业农村部

201918

附件

进口兽药注册目录 

兽药名称 

生产厂名称 

 

进口兽药注册证书号 

有效 

期限 

备注 

头孢氨苄片(75mg 

CEFALEXIN TABLETS 

法国维克有限公司 

VIRBAC 

法国 

2019 

外兽药证字01 

2019.1.8 

— 

2024.1.7 

再注册 

头孢氨苄片(300mg 

CEFALEXIN TABLETS 

2019 

外兽药证字02 

头孢氨苄片(600mg 

CEFALEXIN TABLETS 

   

2019 

外兽药证字03 

   

鸡传染性法氏囊病活疫苗(LC75株) 

Infectious Bursal Disease VaccineLiveStrain LC75 

德国罗曼动物保健有限公司 

Lohmann Animal Health GmbH 

德国 

2019 

外兽药证字04 

2019.1.8 

— 

2024.1.7 

再注册 

犬瘟热、传染性肝炎、细小病毒病、副流感四联活疫苗 

Canine Distemper, Adenovirus, Parvovirus, Parainfluenza Vaccine, Live 

英特威国际有限公司 

Intervet International B.V. 

荷兰 

2019 

外兽药证字05 

2019.1.8 

— 

2024.1.7 

再注册 


In accordance with Regulations on Administration of Veterinary Drugs and the Measures for Registration of Veterinary Drugs, the Ministry of Agriculture and Rural Affairs (MARA) examined and approved the re-registration of three kinds of veterinary drugs including Cefalexin tablets produced by VIRBAC, France, and other two enterprises. The MARA issued the Registration Certificate for Imported Veterinary Drugs and published the revised product quality standards, instruction and label, which will be put into effect on the day of its issuance. Previous product quality standards, instruction and label shall be repealed simultaneously.

 

Annex 1: List of Registration Certificate for Imported Veterinary Drugs 

Annex 2: Quality Standards

Annex 3: Instruction and Label

 

Ministry of Agriculture and Rural Affairs 

 

January 8, 2019

 

Annex 1

List of Registration Certificate for Imported Veterinary Drugs 

 

Name

Manufacturer

Nation 

 Certificate No.

 Validity Period

Remarks

CEFALEXIN TABLETS75mg 

VIRBAC 

France 

(2019)Waishouyaozhengzi

No.01

2019.1.8 

— 

2024.1.7 

Re-registration

CEFALEXIN TABLETS 300mg

(2019)Waishouyaozhengzi

No.02 

CEFALEXIN TABLETS 600mg

(2019)Waishouyaozhengzi

No.03

Infectious Bursal Disease VaccineLiveStrain LC75 

 Lohmann Animal Health GmbH 

Germany 

(2019)Waishouyaozhengzi

No.04

2019.1.8 

— 

2024.1.7 

Re-registration

Canine Distemper, Adenovirus, Parvovirus, Parainfluenza Vaccine, Live 

Intervet International B.V. 

Netherland 

(2019)Waishouyaozhengzi

No.05

2019.1.8 

— 

2024.1.7 

Re-registration

 
 
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