Veterinary Medicines

Benazepril hydrochloride Le Vet 20 mg tablets for dogs

Authorised
  • Benazepril hydrochloride
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Product identification

Medicine name:
Benazepril hydrochloride Le Vet 20 mg tablets for dogs
Benakor F 20 mg tablety pre psov
Active substance:
  • Benazepril hydrochloride
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Benazepril hydrochloride
    20.00
    milligram(s)
    /
    1.00
    Piece
Pharmaceutical form:
  • Tablet
Withdrawal period by route of administration:
  • Oral use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QC09AA07
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Slovakia
Package description:
  • Carton box containing 5 Alu-Alu -foil blisters blisters of 14 tablets each
  • Carton box containing 6 Alu-Alu -foil blisters blisters of 14 tablets each
  • Carton box containing 5 PVC-PE-PVDC-Alu-foil blisters of 14 tablets each
  • Carton box containing 2 PVC-PE-PVDC-Alu-foil blisters of 14 tablets each
  • Carton box containing 1 PVC-PE-PVDC-Alu-foil blisters of 14 tablets
  • Carton box containing 4 PVC-PE-PVDC-Alu-foil blisters of 14 tablets each
  • Carton box containing 3 Alu-Alu -foil blisters blisters of 14 tablets each
  • Carton box containing 6 PVC-PE-PVDC-Alu-foil blisters of 14 tablets each
  • Carton box containing 2 Alu-Alu -foil blisters blisters of 14 tablets each
  • Carton box containing 4 Alu-Alu -foil blisters blisters of 14 tablets each
  • Carton box containing 3 PVC-PE-PVDC-Alu-foil blisters of 14 tablets each
  • Carton box containing 7 PVC-PE-PVDC-Alu-foil blisters of 14 tablets each
  • Carton box containing 7 Alu-Alu -foil blisters blisters of 14 tablets each
  • Carton box containing 1 Alu-Alu-foil blisters blisters of 14 tablets

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Lelypharma B.V.
Responsible authority:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 96/025/DC/08-S
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0126/003
Concerned member states:
  • Austria
  • Belgium
  • Czechia
  • Estonia
  • Finland
  • France
  • Ireland
  • Italy
  • Luxembourg
  • Norway
  • Poland
  • Portugal
  • Slovakia
  • Spain

Documents

Combined File of all Documents

English (PDF)
Published on: 8/04/2023
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Slovak (PDF)
Published on: 18/03/2024
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