Veterinary Medicines

ICTHIOVAC-STR ESTREPTOCOCOSIS RODABALLO Suspension for injection

Authorised
  • Streptococcus parauberis, strain AZ-12.1, Inactivated
  • Streptococcus parauberis, strain RA-99.1, Inactivated
Download as PDF

Product identification

Medicine name:
ICTHIOVAC-STR ESTREPTOCOCOSIS RODABALLO Suspension for injection
ICTHIOVAC-STR STREPTOCOCCOSE TURBOT SUSPENSION INJECTABLE
Active substance:
  • Streptococcus parauberis, strain AZ-12.1, Inactivated
  • Streptococcus parauberis, strain RA-99.1, Inactivated
Target species:
  • Turbot
Route of administration:
  • Intraperitoneal use

Product details

Active substance and strength:
  • Streptococcus parauberis, strain AZ-12.1, Inactivated
    75.00
    Relative Percentage Survival
    /
    0.10
    millilitre(s)
  • Streptococcus parauberis, strain RA-99.1, Inactivated
    75.00
    Relative Percentage Survival
    /
    0.10
    millilitre(s)
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Intraperitoneal use
    • Turbot
      • Meat
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI10D
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • France
Package description:
  • bottle of 500 ml

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/9255948 6/2005
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0109/001
Concerned member states:
  • France
  • Greece
  • Portugal

Documents

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: 18/10/2024
Download

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
Download

Combined File of all Documents

English (PDF)
Published on: 24/07/2025
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."