Biocan Novel Pi L4, Lyophilisate and solvent for suspension for injection
Biocan Novel Pi L4, Lyophilisate and solvent for suspension for injection
Authorised
- Canine parainfluenza virus 2, strain CPiV-2-Bio 15, Live
- Leptospira interrogans, serogroup Icterohaemorrhagiae, serovar Icterohaemorrhagiae, strain MSLB 1089, Inactivated
- Leptospira interrogans, serogroup Canicola, serovar Canicola, strain MSLB 1090, Inactivated
- Leptospira interrogans, serogroup Australis, serovar Bratislava, strain MSLB 1088, Inactivated
- Leptospira kirschneri, serogroup Grippotyphosa, serovar Grippotyphosa, strain MSLB 1091, Inactivated
Product identification
Medicine name:
Biocan Novel Pi L4, Lyophilisate and solvent for suspension for injection
BIOCAN NOVEL Pi/L4, liofilizat și suspensie pentru suspensie injectabilă pentru câini
Active substance:
- Canine parainfluenza virus 2, strain CPiV-2-Bio 15, Live
- Leptospira interrogans, serogroup Icterohaemorrhagiae, serovar Icterohaemorrhagiae, strain MSLB 1089, Inactivated
- Leptospira interrogans, serogroup Canicola, serovar Canicola, strain MSLB 1090, Inactivated
- Leptospira interrogans, serogroup Australis, serovar Bratislava, strain MSLB 1088, Inactivated
- Leptospira kirschneri, serogroup Grippotyphosa, serovar Grippotyphosa, strain MSLB 1091, Inactivated
Target species:
-
Dog
Route of administration:
-
Subcutaneous use
Product details
Active substance and strength:
-
Canine parainfluenza virus 2, strain CPiV-2-Bio 15, Live5.10log10 tissue culture infective dose 501.00Dose
-
Leptospira interrogans, serogroup Icterohaemorrhagiae, serovar Icterohaemorrhagiae, strain MSLB 1089, Inactivated51.00Antibody microagglutination-lytic reaction1.00Dose
-
Leptospira interrogans, serogroup Canicola, serovar Canicola, strain MSLB 1090, Inactivated51.00Antibody microagglutination-lytic reaction1.00Dose
-
Leptospira interrogans, serogroup Australis, serovar Bratislava, strain MSLB 1088, Inactivated51.00Antibody microagglutination-lytic reaction1.00Dose
-
Leptospira kirschneri, serogroup Grippotyphosa, serovar Grippotyphosa, strain MSLB 1091, Inactivated40.00Antibody microagglutination-lytic reaction1.00Dose
Pharmaceutical form:
-
Lyophilisate and solvent for suspension for injection
Withdrawal period by route of administration:
-
Subcutaneous use
- Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QI07AI08
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Romania
Package description:
- Glass Vial 10 x 1.0 Dose
- Glass Vial 25 x 1.0 Dose
- Glass Vial 50 x 1.0 Dose
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:
- Bioveta a.s.
Marketing authorisation date:
Manufacturing sites for batch release:
- Bioveta a.s.
Responsible authority:
- Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
- 190279
Date of authorisation status change:
Reference member state:
-
Czechia
Procedure number:
- CZ/V/0123/001
Concerned member states:
-
Bulgaria
-
Croatia
-
Cyprus
-
Estonia
-
Hungary
-
Latvia
-
Lithuania
-
Poland
-
Romania
-
Slovakia
-
Slovenia
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
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in another language below.
Romanian (PDF)
Published on: 3/03/2022
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