Veterinary Medicines

ALPHA JECT micro 2000 emulsion for injection for sea bass

Authorised
  • Vibrio anguillarum, serotype O1, strain AL 112, Inactivated
  • Photobacterium damselae subsp. piscicida, strain AL 5051, Inactivated
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Product identification

Medicine name:
ALPHA JECT micro 2000 emulsion for injection for sea bass
ALPHA JECT micro 2000 emulsione iniettabile per branzino
Active substance:
  • Vibrio anguillarum, serotype O1, strain AL 112, Inactivated
  • Photobacterium damselae subsp. piscicida, strain AL 5051, Inactivated
Target species:
  • Seabass
Route of administration:
  • Intraperitoneal use

Product details

Active substance and strength:
  • Vibrio anguillarum, serotype O1, strain AL 112, Inactivated
    2.50
    antigen unit(s)
    /
    0.05
    millilitre(s)
  • Photobacterium damselae subsp. piscicida, strain AL 5051, Inactivated
    9.60
    log2 geometric mean titre
    /
    0.05
    millilitre(s)
Pharmaceutical form:
  • Emulsion for injection
Withdrawal period by route of administration:
  • Intraperitoneal use
    • Seabass
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI10X
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Italy
Package description:
  • 10 bags of 500 ml
  • 500 ml bag corresponding to approximately 10000 doses.
  • 250 ml bag corresponding to approximately 5 000 doses.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - Known active substance (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:
  • Ministry Of Health
Authorisation number:
  • 105542
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0306/001
Concerned member states:
  • Croatia
  • France
  • Greece
  • Italy

Documents

Combined File of all Documents

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Italian (PDF)
Published on: 11/04/2022
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Summary of Product Characteristics

English (PDF)
Published on: 24/03/2023
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