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 EMULSION INYECTABLE PARA LUBINA
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:
  • Spain
Available in:
  • Spain
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:
  • The Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 4031 ESP
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0306/001
Concerned member states:
  • Croatia
  • France
  • Greece
  • Italy

Documents

Summary of Product Characteristics

English (PDF)
Published on: 24/03/2023
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Spanish (PDF)
Published on: 2/02/2024
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 2/02/2024
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 2/02/2024
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es-puar-alpha-ject-micro-2000-emulsion-for-injection-for-sea-bass-es.pdf

Spanish (PDF)
Published on: 17/03/2023
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