Nobivac Lepto
Nobivac Lepto
Authorised
- Leptospira interrogans, serogroup Canicola, serovar Portland-vere, strain Ca-12-000, Inactivated
- Leptospira interrogans, serogroup Icterohaemorrhagiae, serovar Copenhageni, strain Ic-02-001, Inactivated
Product identification
Medicine name:
Nobivac Lepto
Nobivac lepto, suspensie voor injectie voor honden
Active substance:
- Leptospira interrogans, serogroup Canicola, serovar Portland-vere, strain Ca-12-000, Inactivated
- Leptospira interrogans, serogroup Icterohaemorrhagiae, serovar Copenhageni, strain Ic-02-001, Inactivated
Target species:
-
Dog
Route of administration:
-
Subcutaneous use
Product details
Active substance and strength:
-
Leptospira interrogans, serogroup Canicola, serovar Portland-vere, strain Ca-12-000, Inactivated990.00/unit(s)1.00millilitre(s)
-
Leptospira interrogans, serogroup Icterohaemorrhagiae, serovar Copenhageni, strain Ic-02-001, Inactivated699.00/unit(s)1.00millilitre(s)
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:
-
Valid
Authorised in:
-
Netherlands
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 Nederland B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
- INTERVET INTERNATIONAL B.V.
Responsible authority:
- Medicines Evaluation Board
Authorisation number:
- REG NL 9243
Date of authorisation status change:
Reference member state:
-
Netherlands
Procedure number:
- NL/V/0108/001
Concerned member states:
-
Belgium
-
Denmark
-
Greece
-
Luxembourg
-
Portugal
-
Spain
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Combined File of all Documents
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Dutch (PDF)
Published on: 25/01/2022
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