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-authorisation applicant |
Bayer HealthCare AG
|
Date of opinion |
14/09/2006
|
Date of refusal of marketing authorisation |
11/12/2006
|