unitedkingdomveterinarymedicinesdirectoratewoodhamlane.docVIP

United Kingdom Veterinary Medicines Directorate Woodham Lane New Haw Addlestone Surrey KT15 3LS MUTUAL RECOGNITION PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY MEDICINAL PRODUCT Pimocard 1.25 mg Flavoured Tablets for Dogs Pimocard 2.5 mg Flavoured Tablets for Dogs Pimocard 5 mg Flavoured Tablets for Dogs Pimocard 10 mg Flavoured Tablets for Dogs Cardisure 1.25 mg Flavoured Tablets for Dogs Cardisure 2.5 mg Flavoured Tablets for Dogs Cardisure 5 mg Flavoured Tablets for Dogs Cardisure 10 mg Flavoured Tablets for Dogs (Czech Republic, Hungary, Slovakia and Slovenia only) Pimosure 1.25 mg Flavoured Tablets for Dogs Pimosure 2.5 mg Flavoured Tablets for Dogs Pimosure 5 mg Flavoured Tablets for Dogs Pimosure 10 mg Flavoured Tablets for Dogs (Portugal and Spain only) Date Created: April 2016 MODULE 1 PRODUCT SUMMARY EU Procedure number UK/V/0580/001-4/MR Name, strength and pharmaceutical form Pimocard 1.25 mg Flavoured Tablets for Dogs Pimocard 2.5 mg Flavoured Tablets for Dogs Pimocard 5 mg Flavoured Tablets for Dogs Pimocard 10 mg Flavoured Tablets for Dogs Applicant Eurovet Animal Health B.V. Handelsweg 25 5531 AE Bladel The Netherlands Active substance(s) Pimobendan ATC Vetcode QC01CE90 Target species Dogs Indication for use For the treatment of canine congestive heart failure originating from valvular insufficiency (mitral and/or tricuspid regurgitation) or dilated cardiomyopathy. MODULE 2 The Summary of Product Characteristics (SPC) for this product is available on the Product Information Database of the Veterinary Medicines Directorate. (.uk/check-animal-medicine-licensed)  MODULE 3 PUBLIC ASSESSMENT REPORT Legal basis of original application Generic application in accordance with Article 13 (1) of Directive 2001/82/EC as amended. Date of completion of the original mutual recognition procedure 21 October 2015 Date product first authorised in the Reference Member State (MRP only) 15 June 2012 Concerned