Veterinary Medicines

PRILACTONE NEXT 10 MG COMPRIME A CROQUER POUR CHIENS

Not authorised
  • Spironolactone
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Product identification

Medicine name:
TEMPORA 10 mg
PRILACTONE NEXT 10 MG COMPRIME A CROQUER POUR CHIENS
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:
  • Surrendered
Authorised in:
  • Romania
Package description:
  • Boîte de 2 plaquettes thermoformées de 10 comprimés
  • Boîte de 3 plaquettes thermoformées de 10 comprimés
  • Boîte de 6 plaquettes thermoformées de 10 comprimés
  • Boîte de 10 plaquettes thermoformées de 10 comprimés
  • Boîte de 18 plaquettes thermoformées de 10 comprimés
  • Boîte de 1 plaquette thermoformée de 10 comprimés

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:
  • Sogeval
Marketing authorisation date:
Manufacturing sites for batch release:
  • Ceva Sante Animale
Responsible authority:
  • ICBMV
Authorisation number:
  • 130009
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0235/001/DC

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Romanian (PDF)
Published on: 16/02/2023
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eu-puar-frv0235001-mr-rpe_66-en.pdf

English (PDF)
Published on: 7/01/2026
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