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Updated product information for injectable veterinary medicines containing enrofloxacin

Notice type: Advisory

Date: 30/04/2015

 Following the outcome of a referral procedure to the European Medicines Agency in September 2014, the product information, including the designated withdrawal periods, for products containing the antibiotic enrofloxacin is being updated.

Product name or type:
Enrofloxacin containing injectable veterinary medicines

Target Audience:
Veterinary practitioners, pharmacists and farmers.

Problem Or Issue:
Following the outcome of a referral procedure to the European Medicines Agency in September 2014, the product information, including the designated withdrawal periods, for products containing the antibiotic enrofloxacin is being updated.

Background Information Or Related Documents:
The summary of product characteristics (SPCs) and information associated with the following products has been or is currently being updated in line with the outcome of the referral procedure:

Product name                         Marketing authorisation number
Enrocare 25 mg/ml                     VPA 10778/7/1
Enrocare 50 mg/ml                     VPA 10778/7/2
Enrocare 100 mg/ml                   VPA 10778/7/3
Baytril 2.5%                                 VPA 10021/6/1
Baytril 5%                                    VPA 10021/20/2
Baytril 10%                                  VPA 10021/3/1
Floxibac 50 mg/ml                       VPA 10987/71/1
Floxibac 100 mg/ml                     VPA 10987/71/2
Fenoflox 50 mg/ml                       VPA 10987/72/1
Fenoflox 100 mg/ml                     VPA 10987/71/2
Enrotron 25 mg/ml                       VPA 10806/2/1
Enrotron 50 mg/ml                       VPA 10806/2/2
Enrotron 100 mg/ml                     VPA 10806/2/3
Quinoflox 100 mg/ml                    VPA 10477/1/1
Enrodexil 100 mg/ml                    VPA 10609/4/1
Enroxil 50 mg/ml                          VPA 10774/2/2
Enroxil 100 mg/ml                        VPA 10774/2/3
Roxacin 100 mg/ml                      VPA 10665/2/1
Doraflox 100 mg/ml                     VPA 10791/9/1
Unisol 100 mg/ml                        VPA 10516/1/1
 

Actions To Be Taken:
  • Veterinary practitioners and pharmacists should ensure that the updated information is being used when prescribing or dispensing veterinary medicines.
  • Users should take note of the new information and use products accordingly.
 

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