Nobivac Lepto
Nobivac Lepto
Not authorised
- Leptospira interrogans, serogroup Icterohaemorrhagiae, serovar Copenhageni, strain Ic-02-001, Inactivated
- Leptospira interrogans, serogroup Canicola, serovar Portland-vere, strain Ca-12-000, Inactivated
Product identification
Medicine name:
Nobivac Lepto
Nobivac Lepto Suspensie voor injectie
Nobivac Lepto Suspension injectable
Nobivac Lepto Injektionssuspension
Active substance:
- Leptospira interrogans, serogroup Icterohaemorrhagiae, serovar Copenhageni, strain Ic-02-001, Inactivated
- Leptospira interrogans, serogroup Canicola, serovar Portland-vere, strain Ca-12-000, Inactivated
Target species:
-
Dog
Route of administration:
-
Subcutaneous use
Product details
Active substance and strength:
-
Leptospira interrogans, serogroup Icterohaemorrhagiae, serovar Copenhageni, strain Ic-02-001, Inactivated699.00/unit(s)1.00Dose
-
Leptospira interrogans, serogroup Canicola, serovar Portland-vere, strain Ca-12-000, Inactivated990.00/unit(s)1.00Dose
Pharmaceutical form:
-
Suspension for injection
Withdrawal period by route of administration:
-
Subcutaneous use
- Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QI07AB01
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Surrendered
Authorised in:
-
Belgium
Package description:
- Plasic box containing 50 type I glass vials of 1 ml (1 dose) closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap
- Plasic box containing 10 type I glass vials of 1 ml (1 dose) closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap
- Cardboard box containing 50 type I glass vials of 1 ml (1 dose) closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap
- Cardboard box containing 10 type I glass vials of 1 ml (1 dose) closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Legal basis not covered by Directive 2001/82/EC
Marketing authorisation holder:
- Intervet International B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
- INTERVET INTERNATIONAL B.V.
Responsible authority:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V259025
Date of authorisation status change:
Reference member state:
-
Netherlands
Procedure number:
- NL/V/0108/001
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
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Package Leaflet
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