Veterinary Medicines

ALPHA JECT 2000 emulsion for injection for sea bass

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

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

Product details

Active substance and strength:
  • Photobacterium damselae, subsp. piscicida, strain AL 5051, Inactivated
    60.00
    Relative Percentage Survival
    /
    0.10
    millilitre(s)
  • Vibrio anguillarum, serotype O1, strain AL 112, Inactivated
    75.00
    Relative Percentage Survival
    /
    0.10
    millilitre(s)
Pharmaceutical form:
  • Emulsion for injection
Withdrawal period by route of administration:
  • Intraperitoneal use
    • Seabass
      • Meat
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI10X
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Spain
Package description:
  • bottle of 500 ml

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Well-established use application (Article 13a of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Pharmaq AS
Marketing authorisation date:
Manufacturing sites for batch release:
  • Pharmaq AS
Responsible authority:
  • Spanish Agency For Medicines And Medical Devices
Authorisation number:
  • 3633 ESP
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0316/001
Concerned member states:
  • Croatia

Documents

Summary of Product Characteristics

English (PDF)
Published on: 12/04/2023
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Spanish (PDF)
Published on: 17/03/2023
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Package Leaflet

English (PDF)
Published on: 12/04/2023
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Spanish (PDF)
Published on: 17/03/2023
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Labelling

English (PDF)
Published on: 12/04/2023
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Spanish (PDF)
Published on: 17/03/2023
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Combined File of all Documents

English (PDF)
Published on: 21/11/2022
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es-puar-alpha-ject-2000-emulsion-for-injection-for-sea-bass-es.pdf

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