Veterinary Medicines

Norvax compact PD emulsion for injection for Atlantic salmon

Authorised
  • Salmon pancreas disease virus, strain F93-125, Inactivated
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Product identification

Medicine name:
Norvax compact PD emulsion for injection for Atlantic salmon
Norvax compact PD emulsion for injection for Atlantic salmon
Active substance:
  • Salmon pancreas disease virus, strain F93-125, Inactivated
Target species:
  • Atlantic salmon
Route of administration:
  • Intraperitoneal use

Product details

Active substance and strength:
  • Salmon pancreas disease virus, strain F93-125, Inactivated
    50118700.00
    tissue culture infective dose 50
    /
    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:
  • QI10AA01
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. Pack size: 250 ml (2,500 doses).
  • Bottles of polyethylene terephthalate (PET) closed with a rubber stopper and aluminium cap. Pack 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:
  • VPA10996/213/001
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0257/001
Concerned member states:
  • Norway
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 8/03/2023
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