Veterinary Medicines

ICTHIOVAC VR/PD, EMULSION FOR INJECTION FOR SEA BASS

Authorised
  • Photobacterium damselae, subsp. Piscicida, strain DI21, Inactivated
  • Vibrio anguillarum, serotype O1, Inactivated
  • Vibrio anguillarum, serotype O2b, Inactivated
  • Vibrio anguillarum, serotype O2a, Inactivated
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Product identification

Medicine name:
ICTHIOVAC VR/PD EMULSION INJECTABLE POUR BARS
ICTHIOVAC VR/PD, EMULSION FOR INJECTION FOR SEA BASS
ICTHIOVAC VR/PD, emulsione iniettabile per spigole
Active substance:
  • Photobacterium damselae, subsp. Piscicida, strain DI21, Inactivated
  • Vibrio anguillarum, serotype O1, Inactivated
  • Vibrio anguillarum, serotype O2b, Inactivated
  • Vibrio anguillarum, serotype O2a, Inactivated
Target species:
  • Seabass
Route of administration:
  • Intraperitoneal use

Product details

Active substance and strength:
  • Photobacterium damselae, subsp. Piscicida, strain DI21, Inactivated
    60.00
    Relative Percentage Survival
    /
    1.00
    Dose
  • Vibrio anguillarum, serotype O1, Inactivated
    75.00
    Relative Percentage Survival
    /
    1.00
    Dose
  • Vibrio anguillarum, serotype O2b, Inactivated
    75.00
    Relative Percentage Survival
    /
    1.00
    Dose
  • Vibrio anguillarum, serotype O2a, Inactivated
    75.00
    Relative Percentage Survival
    /
    1.00
    Dose
Pharmaceutical form:
  • Emulsion for injection
Withdrawal period by route of administration:
  • Intraperitoneal use
    • Seabass
      • Fish meat
        0
        degree 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:
  • 500 ml bottle

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/3638521 0/2017
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0314/001
Concerned member states:
  • Croatia
  • Cyprus
  • Greece
  • Italy
  • Portugal
  • Spain

Documents

Combined File of all Documents

English (PDF)
Published on: 19/02/2024
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Italian (PDF)
Published on: 22/06/2022
Updated on: 23/06/2022
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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: 25/01/2023
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Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 25/01/2023
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