Distemink Vet, lyophilisate and solvent for suspension for injection for minks
Distemink Vet, lyophilisate and solvent for suspension for injection for minks
Authorised
- Canine distemper virus, strain Lederle, Live
- Water for injection
Product identification
Medicine name:
Distemink Vet, lyophilisate and solvent for suspension for injection for minks
Active substance:
- Canine distemper virus, strain Lederle, Live
- Water for injection
Target species:
-
Mink
Route of administration:
-
Subcutaneous use
Product details
Active substance and strength:
-
Canine distemper virus, strain Lederle, Live3.00/log10 unit(s)1.00millilitre(s)
-
Water for injection1.00/millilitre(s)1.00millilitre(s)
Pharmaceutical form:
-
Suspension for injection
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QI20CD01
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Denmark
Package description:
- Type 1 glass vials closed with a rubber stopper and sealed with an aluminum cap. Pack containing 1 vial of 250 doses of lyophilisate (per dose of 1 ml).
- Type 1 glass vials closed with a rubber stopper and sealed with an aluminum cap. Pack containing 1 vial of 100 doses of lyophilisate (per dose of 1 ml).
- 1 vial of 250 ml of solvent
- 1 vial of 100 ml of solvent
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Similar biological application (Article 13(4) of Directive No 2001/82/EC)
Marketing authorisation holder:
- United Vaccines Holding B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
- Cooeperative Federation Of Nobel Animal Keepers Nederasselt U.A.
Responsible authority:
- Danish Medicines Agency
Authorisation number:
- 59726
Date of authorisation status change:
Reference member state:
-
Netherlands
Procedure number:
- NL/V/0238/001
Concerned member states:
-
Denmark
-
Finland
-
Greece
-
Italy
-
Latvia
-
Lithuania
-
Norway
-
Poland
-
Romania
-
Spain
-
Sweden
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
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Danish (, LYOFILISAT OG SOLVENS TIL INJEKTIONSVÆSKE, SUSPENSION)
Published on: 29/06/2023