Authorised

Product identification

Medicine name:
AquaVac PD3 emulsion for injection for Atlantic salmon
AquaVac PD3 emulsion for injection for Atlantic salmon
Active substance:
  • Aeromonas salmonicida, subsp. salmonicida, Inactivated
  • Salmon pancreas disease virus, strain F93-125, Inactivated
  • Infectious pancreatic necrosis virus, Inactivated
Target species:
  • Atlantic salmon
Route of administration:
  • Intraperitoneal use

Product details

Active substance and strength:
  • Aeromonas salmonicida, subsp. salmonicida, Inactivated
    80.00
    Relative Percentage Survival
    /
    1.00
    Dose
  • Salmon pancreas disease virus, strain F93-125, Inactivated
  • Infectious pancreatic necrosis virus, Inactivated
    1.50
    enzyme-linked immunosorbent assay unit
    /
    1.00
    Dose
Pharmaceutical form:
  • Emulsion for injection
Withdrawal period by route of administration:
  • Intraperitoneal use
    • Atlantic salmon
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI10AL
Authorisation status:
  • Valid
Authorised in:
  • Ireland
Package description:
  • Bottles of polyethylene terephthalate (PET) closed with a rubber stopper and aluminium cap.Package size: 500 ml (5,000 doses).

Additional information

Entitlement type:
  • Marketing Authorisation
Marketing authorisation holder:
  • Intervet (Ireland) Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Intervet International B.V.
Responsible authority:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA10996/274/001
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0339/001
Concerned member states:
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 6/04/2025
Download

Combined File of all Documents

English (PDF)
Published on: 6/04/2025
Download

Source URL: https://medicines.health.europa.eu/veterinary/600000051133