Veterinary Medicines

PRILACTONE NEXT 50 MG CHEWABLE TABLETS FOR DOGS

Authorised
  • Spironolactone
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Product identification

Medicine name:
PRILACTONE NEXT 50 MG CHEWABLE TABLETS FOR DOGS
Prilactone vet 50 mg purutabletti
Active substance:
  • Spironolactone
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Spironolactone
    50.00
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Chewable tablet
Withdrawal period by route of administration:
  • Oral use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QC03DA01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Finland
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 Sante Animale
Marketing authorisation date:
Manufacturing sites for batch release:
  • Ceva Sante Animale
Responsible authority:
  • Finnish Medicines Agency
Authorisation number:
  • 29734
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0235/002
Concerned member states:
  • Austria
  • Belgium
  • Finland
  • Germany
  • Greece
  • Ireland
  • Italy
  • Luxembourg
  • Netherlands
  • Poland
  • Portugal
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Finnish (PDF)
Published on: 1/10/2024
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Finnish (PDF)
Published on: 1/10/2024
Download

Combined File of all Documents

English (PDF)
Published on: 11/12/2024
Download
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