Veterinary Medicines

ALPHA JECT micro 1 Noda Emulsion for injection for sea bass ALPHA JECT micro 1 VNN Emulsion for

Authorised
  • Redspotted grouper nervous necrosis virus, strain ALV1107, Inactivated
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Product identification

Medicine name:
ALPHA JECT MICRO 1 NODA EMULSION INYECTABLE PARA LUBINA
ALPHA JECT micro 1 Noda Emulsion for injection for sea bass ALPHA JECT micro 1 VNN Emulsion for
Active substance:
  • Redspotted grouper nervous necrosis virus, strain ALV1107, Inactivated
Target species:
  • Seabass
Route of administration:
  • Intraperitoneal use

Product details

Active substance and strength:
  • Redspotted grouper nervous necrosis virus, strain ALV1107, Inactivated
    0.07
    antigen unit(s)
    /
    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
Package description:
  • 10 bags of 500 ml (5000 doses)
  • 10 bags of 500 ml (5000 doses)
  • 10 bags of 500 ml (5000 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:
  • 3597 ESP
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0263/001
Concerned member states:
  • Croatia
  • France
  • Greece
  • Italy

Documents

Summary of Product Characteristics

English (PDF)
Published on: 6/10/2023
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Spanish (PDF)
Published on: 2/02/2024
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Package Leaflet

English (PDF)
Published on: 6/10/2023
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Spanish (PDF)
Published on: 2/02/2024
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Labelling

English (PDF)
Published on: 6/10/2023
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Spanish (PDF)
Published on: 2/02/2024
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eu-PUAR-alpha-ject-micro-1-noda-emulsion-for-injection-for-sea-bass-en.pdf

English (PDF)
Published on: 23/03/2023
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