Veterinary Medicines

ICTHIOVAC-VR

Authorised
  • Vibrio anguillarum, serotype O1, strain R-82, Inactivated
  • Vibrio anguillarum, serotype O2 alpha, strain RG-111, Inactivated
  • Vibrio anguillarum, serotype O2 beta, strain RV-22, Inactivated
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Product identification

Medicine name:
ICTHIOVAC-VR
ICTHIOVAC-VR CONCENTRADO PARA SUSPENSIÓN PARA BAÑO/SUSPENSIÓN INYECTABLE PARA LUBINA Y RODABALLO
Active substance:
  • Vibrio anguillarum, serotype O1, strain R-82, Inactivated
  • Vibrio anguillarum, serotype O2 alpha, strain RG-111, Inactivated
  • Vibrio anguillarum, serotype O2 beta, strain RV-22, Inactivated
Target species:
  • Turbot
  • Seabass
Route of administration:
  • Intraperitoneal use

Product details

Active substance and strength:
  • Vibrio anguillarum, serotype O1, strain R-82, Inactivated
    60.00
    Relative Percentage Survival
    /
    1.00
    millilitre(s)
  • Vibrio anguillarum, serotype O2 alpha, strain RG-111, Inactivated
    60.00
    Relative Percentage Survival
    /
    1.00
    millilitre(s)
  • Vibrio anguillarum, serotype O2 beta, strain RV-22, Inactivated
    60.00
    Relative Percentage Survival
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Intraperitoneal use
    • Turbot
      • Meat
        0
        degree day
    • Seabass
      • Meat
        0
        degree day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI10D
  • QI10X
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Spain
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:
  • Laboratorios Hipra S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Hipra S.A.
Responsible authority:
  • The Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 1467 ESP
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0385/001
Concerned member states:
  • Cyprus
  • France
  • Greece
  • Italy
  • Portugal

Documents

Summary of Product Characteristics

English (PDF)
Published on: 5/04/2023
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Spanish (PDF)
Published on: 17/03/2023
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Combined File of all Documents

English (PDF)
Published on: 21/11/2022
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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: 17/03/2023
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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: 17/03/2023
Download
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