Veterinary Medicines

PYCEZE 500 MG/ML CONCENTRATE FOR SOLUTION FOR FISH TREATMENT

Authorised
  • Bronopol
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Product identification

Medicine name:
PYCEZE 500 MG/ML CONCENTRATE FOR SOLUTION FOR FISH TREATMENT
PYCEZE 500 mg/ml CONCENTRADO PARA SOLUCION PARA TRATAMIENTO DE PECES
Active substance:
  • Bronopol
Target species:
  • Atlantic salmon
  • Trout
Route of administration:
  • Dipping

Product details

Active substance and strength:
  • Bronopol
    500.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Concentrate for solution for fish treatment
Withdrawal period by route of administration:
  • Dipping
    • Atlantic salmon
      • Fish meat
        0
        day
      • Eggs
        no withdrawal period
    • Trout
      • Fish meat
        0
        day
      • Eggs
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QD01AE91
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Spain
Package description:
  • Cardboard box with 1 bottle containing 5 Litres and 1 Polypropylene graduated measuring device (500 mL)
  • Cardboard box with 4 bottles containing 5 Litres and 1 Polypropylene graduated measuring device (500 mL)
  • Bottle of 1 L

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Legal basis not covered by Directive 2001/82/EC
Marketing authorisation holder:
  • CZ Vaccines S.A.U.
Marketing authorisation date:
Manufacturing sites for batch release:
  • CZ Vaccines S.A.U.
Responsible authority:
  • Spanish Agency For Medicines And Medical Devices
Authorisation number:
  • 1961 ESP
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0348/001
Concerned member states:
  • Italy
  • Norway
  • 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.
Spanish (PDF)
Published on: 15/02/2024
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 15/02/2024
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 15/02/2024
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