Veterinary Medicine Information website

PRILACTONE NEXT 10 MG CHEWABLE TABLETS FOR DOGS

Authorised
  • Spironolactone
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Product identification

Medicine name:
PRILACTONE NEXT 10 MG CHEWABLE TABLETS FOR DOGS
Active substance:
  • Spironolactone
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Spironolactone
    10.00
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Chewable tablet
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QC03DA01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Germany
Available in:
  • Germany
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Ceva Tiergesundheit GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Ceva Sante Animale
Responsible authority:
  • Federal Office Of Consumer Protection And Food Safety
Authorisation number:
  • 401575.00.00
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0235/001
Concerned member states:
  • Austria
  • Belgium
  • Finland
  • Germany
  • Greece
  • Ireland
  • Italy
  • Luxembourg
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 14/03/2026
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German (PDF)
Published on: 17/12/2024
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eu-puar-frv0235001-mr-rpe_66-en.pdf

English (PDF)
Published on: 13/03/2026
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