Veterinary Medicines

ICTHIOVAC VNN, EMULSION FOR INJECTION FOR SEA BASS

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

Product identification

Medicine name:
ICTHIOVAC VNN, EMULSION FOR INJECTION FOR SEA BASS
ICTHIOVAC VNN EMULSION INJECTABLE POUR BARS
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
    /
    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
Authorisation status:
  • Valid
Authorised in:
  • France
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:
  • French Agency For Food, Environmental And Occupational Health & Safety
Authorisation number:
  • FR/V/1577399 7/2022
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0349/002
Concerned member states:
  • Croatia
  • Cyprus
  • Greece
  • Italy
  • Portugal
  • Spain
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."