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中华人民共和国农业农村部公告 第131号 Announcement No. 131 of the Ministry of Agriculture and Rural Affairs

DATE:2019-02-21       SOURCE:MARA
 
 根据《兽药管理条例》和《兽药注册办法》规定,经审查,批准梅里亚有限公司等2家公司生产的伊维菌素双羟萘酸噻嘧啶咀嚼片等2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 

       2019124

附件1 

                                               进口兽药注册目录 

兽药名称 

生产厂名称 

国 别 

进口兽药注册证书号 

有效 

期限 

备注 

伊维菌素双羟萘酸噻嘧啶咀嚼片(S片) 

Ivermectin and Pyrantel Pamoate Chewable Tablets 

梅里亚有限公司巴塞洛内塔生产厂 

Merial Barceloneta, LLC 

美国 

2019 

外兽药证字06 

2019.1.24 

 

2024.1.23 

再注册 

伊维菌素双羟萘酸噻嘧啶咀嚼片(M片) 

Ivermectin and Pyrantel Pamoate Chewable Tablets 

2019 

外兽药证字07 

伊维菌素双羟萘酸噻嘧啶咀嚼片(L片) 

Ivermectin and Pyrantel Pamoate Chewable Tablets 

2019 

外兽药证字08 

碘酸混合溶液 

Iodine and Acid Mixed Solution 

  

英国Evans生产厂 

Evans Vanodine International PLC 

英国 

2019 

外兽药证字09 

2019.1.24 

 

2024.1.23 

再注册 


附件:公告131.ceb
说明书和标签.doc



In accordance with Regulations on Administration of Veterinary Drugs and Measures for Registration of Veterinary Drugs, the Ministry of Agriculture and Rural Affairs (MARA) examined and approved the re-registration of two veterinary drugs including Ivermectin and Pyrantel Pamoate Chewable Tablets produced by Merial, Barcelona, and the other enterprise. 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 Previous product quality standards, instruction and label shall be repealed simultaneously.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 24, 2019



Annex 1

List of Registration Certificate for Imported Veterinary Drugs 


Name 

Manufacturer

Nation 

Certificate No. 

Validity Period 

Remarks 

 Ivermectin and Pyrantel Pamoate Chewable Tablets 

 

Merial Barceloneta, LLC 

USA 

(2019)Waishouyaozhengzi

No.06 

2019.1.24 

 

2024.1.23 

 Re-registration

 Ivermectin and Pyrantel Pamoate Chewable Tablets 

(2019)Waishouyaozhengzi

No.07 

 Ivermectin and Pyrantel Pamoate Chewable Tablets 

(2019)Waishouyaozhengzi

No.08 

 

 Iodine and Acid Mixed Solution 

Evans Vanodine International PLC 

UK 

(2019)Waishouyaozhengzi

No.09 

2019.1.24 

 

2024.1.23 

Re-registration




Annex 2: Announcement No. 131.ceb

Annex 3: Instruction and Label.doc


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