File downloaded on 2025-12-10
Source URL: https://medicines.health.europa.eu/veterinary/en/600000043119
Authorised

Product identification

Medicine name:
ICTHIOVAC-PD PASTEURELLOSIS DORADA
ICTHIOVAC-PD PASTEURELLOSIS DORADA SUSPENSION A DILUER POUR TREMPAGE POUR DAURADES ROYALES
Active substance:
  • Photobacterium damselae, subsp. piscicida, strain It-1, Inactivated
  • Photobacterium damselae, subsp. piscicida, strain DI21, Inactivated
Target species:
  • Gilthead
Route of administration:
  • Dipping

Product details

Active substance and strength:
  • Photobacterium damselae, subsp. piscicida, strain It-1, Inactivated
    60.00
    percent
    /
    1.00
    millilitre(s)
  • Photobacterium damselae, subsp. piscicida, strain DI21, Inactivated
    60.00
    percent
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Concentrate for dip suspension
Withdrawal period by route of administration:
  • Dipping
    • Gilthead
      • Meat
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI10X
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription except for some pack sizes
Authorisation status:
  • Valid
Authorised in:
  • France
Package description:
  • bottle of 1 L

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - New active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Laboratorios Hipra S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Hipra S.A.
Responsible authority:
  • French Agency For Food, Environmental And Occupational Health & Safety
Authorisation number:
  • FR/V/1672138 0/2015
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0215/001
Concerned member states:
  • Croatia
  • Cyprus
  • France
  • Greece
  • Italy
  • Portugal

Documents

Summary of Product Characteristics

English (PDF)
Published on: 26/06/2025
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French (PDF)
Published on: 27/09/2023
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Labelling

English (PDF)
Published on: 5/04/2023
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Package Leaflet and Labelling

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 15/10/2025
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Combined File of all Documents

English (PDF)
Published on: 24/07/2025
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eu-PUAR-esv0215001-mrp-icthiovac-pd-pasteurellosis-dorada-en.pdf

English (PDF)
Published on: 26/06/2025
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