Veterinary Medicines

AquaVac PD3 emulsion for injection for Atlantic salmon

Authorised
  • Aeromonas salmonicida, subsp. salmonicida, Inactivated
  • Salmon pancreas disease virus, strain F93-125, Inactivated
  • Infectious pancreatic necrosis virus, Inactivated
Download as PDF

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
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
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
Legal basis of product authorisation:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
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
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."