Nobivac Lepto
Nobivac Lepto
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
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:
-
Valid
Authorised in:
-
Spain
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:
- Merck Sharp & Dohme Animal Health S.L.
Marketing authorisation date:
Manufacturing sites for batch release:
- INTERVET INTERNATIONAL B.V.
Responsible authority:
- (AEMPS)
Authorisation number:
- 1514 ESP
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
Summary of Product Characteristics
This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 22/02/2023
Package Leaflet
This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 22/02/2023
Labelling
This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 22/02/2023
How useful was this page?:
