Veterinary Medicines

ICTHIOVAC VNN, EMULSION FOR INJECTION FOR SEABASS

Authorised
  • Redspotted grouper nervous necrosis virus, strain 1103, Inactivated
Download as PDF

Product identification

Medicine name:
ICTHIOVAC VNN, EMULSION FOR INJECTION FOR SEABASS
ICTHIOVAC VNN EMULSION INYECTABLE PARA LUBINA
Active substance:
  • Redspotted grouper nervous necrosis virus, strain 1103, Inactivated
Target species:
  • Seabass
Route of administration:
  • Intraperitoneal use

Product details

Active substance and strength:
  • Redspotted grouper nervous necrosis virus, strain 1103, Inactivated
    1.30
    relative potency
    /
    0.10
    millilitre(s)
Pharmaceutical form:
  • Emulsion for injection
Withdrawal period by route of administration:
  • Intraperitoneal use
    • Seabass
      • Fish meat
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI10X
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Spain
Package description:
  • 500 ml (5000 doses) high density polyethylene bottles closed with nitrile-chlorobutyl rubber stoppers and aluminium caps.

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:
  • Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 3775 ESP
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0349/002
Concerned member states:
  • Croatia
  • Cyprus
  • Greece
  • Italy
  • Portugal
  • Spain