Veterinary Medicines

ALPHA JECT 3000 Emulsion for injection for Atlantic salmon

Authorised
  • Aeromonas salmonicida, strain AL2017, Inactivated
  • Vibrio anguillarum, serotype O1, strain AL 112, Inactivated
  • Vibrio anguillarum, serotype O2a, strain AL 104, Inactivated
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Product identification

Medicine name:
ALPHA JECT 3000 injeksjonsvæske, emulsjon til atlantisk laks
ALPHA JECT 3000 Emulsion for injection for Atlantic salmon
Active substance:
  • Aeromonas salmonicida, strain AL2017, Inactivated
  • Vibrio anguillarum, serotype O1, strain AL 112, Inactivated
  • Vibrio anguillarum, serotype O2a, strain AL 104, Inactivated
Target species:
  • Atlantic salmon
Route of administration:
  • Intraperitoneal use

Product details

Active substance and strength:
  • Aeromonas salmonicida, strain AL2017, Inactivated
    70.00
    Relative Percentage Survival
    /
    1.00
    Dose
  • Vibrio anguillarum, serotype O1, strain AL 112, Inactivated
    75.00
    Relative Percentage Survival
    /
    1.00
    Dose
  • Vibrio anguillarum, serotype O2a, strain AL 104, Inactivated
    75.00
    Relative Percentage Survival
    /
    1.00
    Dose
Pharmaceutical form:
  • Emulsion for injection
Withdrawal period by route of administration:
  • Intraperitoneal use
    • Atlantic salmon
      • Meat and offal
        0
        degree day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI10AB02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Norway
Available in:
  • Norway
Package description:
  • UVO injection bags made of a multilayer plastic foil with ethylene vinyl acetate as the product contact layer. Thegiving port is closed with a bromobutyl based rubber stopper.Pack size: 500 ml

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:
  • Pharmaq AS
Marketing authorisation date:
Manufacturing sites for batch release:
  • Pharmaq AS
Responsible authority:
  • Norwegian Medical Products Agency
Authorisation number:
  • 07-5472
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0219/001
Concerned member states:
  • Denmark
  • Finland
  • Iceland
  • Norway

Documents

Summary of Product Characteristics

English (PDF)
Published on: 4/05/2025
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Norwegian (PDF)
Published on: 16/05/2025
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Combined File of all Documents

English (PDF)
Published on: 4/05/2025
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Norwegian (PDF)
Published on: 16/05/2025
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