Spirovac
Spirovac
Authorised
- Leptospira borgpetersenii, serovar Hardjo-bovis, Inactivated
Product identification
Medicine name:
Spirovac
Active substance:
- Leptospira borgpetersenii, serovar Hardjo-bovis, Inactivated
Target species:
-
Cattle
Route of administration:
-
Subcutaneous use
Product details
Active substance and strength:
-
Leptospira borgpetersenii, serovar Hardjo-bovis, Inactivated2.00/relative potency2.00millilitre(s)
Pharmaceutical form:
-
Suspension for injection
Withdrawal period by route of administration:
-
Subcutaneous use
-
Cattle
-
Meat and offal0day
-
Milk0day
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QI02AB03
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Portugal
Package description:
- Container: 5 doses (10ml) Glass type I vials.Closure: Chlorobutyl stopper with aluminium overseal.Outer Packaging: Cardboard carton with package insert leaflet.Pack sizes: 5 doses (10 ml).
- Container: 25 doses (50ml) Glass type I vials.Closure: Chlorobutyl stopper with aluminium overseal.Outer Packaging: Cardboard carton with package insert leaflet.Pack sizes: 25 doses (50ml).
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:
- Zoetis Portugal Lda.
Marketing authorisation date:
Manufacturing sites for batch release:
- Zoetis Belgium
Responsible authority:
- Directorate General For Food And Veterinary
Authorisation number:
- 925/01/16RIVPT
Date of authorisation status change:
Reference member state:
-
Ireland
Procedure number:
- IE/V/0420/001
Concerned member states:
-
Germany
-
Portugal
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
