Veterinary Medicines

ALPHA JECT 5-3 injeksjonsvæske, emulsjon, vaksine til atlantisk laks

Not authorised
  • Aeromonas salmonicida, subsp. salmonicida, Inactivated
  • Aliivibrio salmonicida, Inactivated
  • Vibrio anguillarum, serotype O1, Inactivated
  • Vibrio anguillarum, serotype O2a, Inactivated
  • Moritella viscosa, Inactivated
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Product identification

Medicine name:
ALPHA JECT 5-3 injeksjonsvæske, emulsjon, vaksine til atlantisk laks
Alpha ject 5-3 injeksjonsvæske, emulsjon, vaksine til atlantisk laks
Active substance:
  • Aeromonas salmonicida, subsp. salmonicida, Inactivated
  • Aliivibrio salmonicida, Inactivated
  • Vibrio anguillarum, serotype O1, Inactivated
  • Vibrio anguillarum, serotype O2a, Inactivated
  • Moritella viscosa, 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
    /
    0.10
    millilitre(s)
  • Aliivibrio salmonicida, Inactivated
    90.00
    Relative Percentage Survival
    /
    0.10
    millilitre(s)
  • Vibrio anguillarum, serotype O1, Inactivated
    75.00
    Relative Percentage Survival
    /
    0.10
    millilitre(s)
  • Vibrio anguillarum, serotype O2a, Inactivated
    75.00
    Relative Percentage Survival
    /
    0.10
    millilitre(s)
  • Moritella viscosa, Inactivated
    60.00
    Relative Percentage Survival
    /
    0.10
    millilitre(s)
Pharmaceutical form:
  • Emulsion for injection
Withdrawal period by route of administration:
  • Intraperitoneal use
    • Atlantic salmon
      • Meat
        0
        degree day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI10AB03
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Surrendered
Authorised in:
  • Norway
Package description:
  • 500 ml bag

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:
  • 03-1814
Date of authorisation status change:
Reference member state:
  • Norway
Procedure number:
  • NO/V/0005/001

Documents

Summary of Product Characteristics

English (PDF)
Published on: 22/11/2021
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Norwegian (PDF)
Published on: 13/01/2022
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Package Leaflet

English (PDF)
Published on: 22/11/2021
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