ALPHA JECT 3000 Emulsion for injection for Atlantic salmon
ALPHA JECT 3000 Emulsion for injection for Atlantic salmon
Authorised
- Vibrio anguillarum, serotype O2A, strain AL 104, Inactivated
- Aeromonas salmonicida, strain AL2017, Inactivated
- Vibrio anguillarum, serotype O1, strain AL 112, Inactivated
Product identification
Medicine name:
ALPHA JECT 3000 injektioneste, emulsio
ALPHA JECT 3000 Emulsion for injection for Atlantic salmon
Active substance:
- Vibrio anguillarum, serotype O2A, strain AL 104, Inactivated
- Aeromonas salmonicida, strain AL2017, Inactivated
- Vibrio anguillarum, serotype O1, strain AL 112, Inactivated
Target species:
-
Atlantic salmon
Route of administration:
-
Intraperitoneal use
Product details
Active substance and strength:
-
Vibrio anguillarum, serotype O2A, strain AL 104, Inactivated75.00Relative Percentage Survival1.00Dose
-
Aeromonas salmonicida, strain AL2017, Inactivated70.00Relative Percentage Survival1.00Dose
-
Vibrio anguillarum, serotype O1, strain AL 112, Inactivated75.00Relative Percentage Survival1.00Dose
Pharmaceutical form:
-
Emulsion for injection
Withdrawal period by route of administration:
-
Intraperitoneal use
- Atlantic salmon
-
Meat and offal0day
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QI10AB02
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Finland
Package description:
- UVO injection bags made of a multilayer plastic foil with ethylene vinyl acetate as the product contact layer. The giving port is closed with a bromobutyl based rubber stopper. Pack size: 500 ml
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Full application (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:
- FIMEA
Authorisation number:
- 24478
Date of authorisation status change:
Reference member state:
-
Ireland
Procedure number:
- IE/V/0219/001
Concerned member states:
-
Denmark
-
Finland
-
Iceland
-
Norway
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
English (PDF)
Download Published on: 8/04/2022
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