Veterinary Medicines

ICTHIOVAC VNN, EMULSION FOR INJECTION FOR SEA BASS

Authorised
  • Redspotted grouper nervous necrosis virus, strain 1103, Inactivated
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Product identification

Medicine name:
ICTHIOVAC VNN, EMULSION FOR INJECTION FOR SEA BASS
ICTHIOVAC VNN, emulsione iniettabile per spigole
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:
  • Italy
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:
  • Ministry Of Health
Authorisation number:
  • 105254
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0349/002
Concerned member states:
  • Croatia
  • Cyprus
  • Greece
  • Italy
  • Portugal
  • Spain

Documents

Combined File of all Documents

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Italian (PDF)
Published on: 16/11/2023
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Summary of Product Characteristics

English (PDF)
Published on: 15/02/2024
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