Veraflox

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pradofloxacin

Refused
This medicine was refused authorisation for use in the European Union.

Overview

On 17 May 2006 the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Veraflox 15 mg, 60 mg and 120 mg tablets for cats and dogs, and Veraflox 25 mg/ml oral suspension for cats. The applicant requested a re-examination of the opinion. After having considered the grounds for this request, the CVMP re-examined the initial opinion, and confirmed the recommendation of the refusal of the marketing authorisation application on 14 September 2006.

The company who applied for a marketing authorisation is Bayer HealthCare AG.

This EPAR was last updated on 24/01/2007

Application details

Product details
Name
Veraflox
Active substance
pradofloxacin
International non-proprietary name (INN) or common name
pradofloxacin
Species
Dogs
Application details
Marketing-autorisation applicant
Bayer HealthCare AG
Date of opinion
14/09/2006
Date of refusal of marketing authorisation
11/12/2006

Assessment history

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