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
Download as PDF

Product identification

Medicine name:
ALPHA JECT micro 1 Noda Emulsion for injection for sea bass ALPHA JECT micro 1 VNN Emulsion for
ALPHA JECT micro 1 Noda, emulsione iniettabile per branzino
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:
  • Italy
Available in:
  • Italy
Package description:
  • 10 bags of 500 ml (5000 doses)
  • bag of 500 ml (10000 doses)
  • bag of 250 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:
  • Ministry Of Health
Authorisation number:
  • 105071
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0263/001
Concerned member states:
  • Croatia
  • Cyprus
  • France
  • Greece
  • Italy

Documents

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Italian (PDF)
Published on: 2/05/2024
Download

Summary of Product Characteristics

English (PDF)
Published on: 6/10/2023
Updated on: 7/10/2023
Download

Package Leaflet

English (PDF)
Published on: 6/10/2023
Updated on: 7/10/2023
Download

Labelling

English (PDF)
Published on: 6/10/2023
Updated on: 7/10/2023
Download

eu-PUAR-alpha-ject-micro-1-noda-emulsion-for-injection-for-sea-bass-en.pdf

English (PDF)
Published on: 23/03/2023
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."