File downloaded on 2026-04-16
Source URL: https://medicines.health.europa.eu/veterinary/en/600000043134
Authorised

Product identification

Medicine name:
ICTHIOVAC-STR ESTREPTOCOCOSIS RODABALLO Suspension for injection
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:
  • Portugal
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:
  • Directorate General For Food And Veterinary
Authorisation number:
  • R752/05DGV
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0109/001
Concerned member states:
  • France
  • Greece
  • Portugal

Documents

Combined File of all Documents

English (PDF)
Published on: 24/07/2025
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