Veterinary Medicines

Biocan Novel DHPPi/L4R, Lyophilisate and solvent for suspension for injection

Authorised
  • Canine distemper virus, strain CDV Bio 11/A, Live
  • Canine adenovirus 2, strain CAV-2-Bio 13, Live
  • Canine parvovirus 2b, strain CPV-2b Bio 12/B, Live
  • 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
  • Rabies virus, strain SAD Vnukovo-32, Inactivated
  • Leptospira interrogans, serogroup Australis, serovar Bratislava, Inactivated
  • Leptospira kirschneri, Serogroup Grippotyphosa, Inactivated
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Product identification

Medicine name:
Biocan Novel DHPPi/L4R, Lyophilisate and solvent for suspension for injection
BIOCAN NOVEL DHPPi/L4R, liofilizat și suspensie pentru suspensie injectabilă pentru câini
Active substance:
  • Canine distemper virus, strain CDV Bio 11/A, Live
  • Canine adenovirus 2, strain CAV-2-Bio 13, Live
  • Canine parvovirus 2b, strain CPV-2b Bio 12/B, Live
  • 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
  • Rabies virus, strain SAD Vnukovo-32, Inactivated
  • Leptospira interrogans, serogroup Australis, serovar Bratislava, Inactivated
  • Leptospira kirschneri, Serogroup Grippotyphosa, Inactivated
Target species:
  • Dog
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Canine distemper virus, strain CDV Bio 11/A, Live
    5.10
    log10 tissue culture infective dose 50
    /
    1.00
    Dose
  • Canine adenovirus 2, strain CAV-2-Bio 13, Live
    5.30
    log10 tissue culture infective dose 50
    /
    1.00
    Dose
  • Canine parvovirus 2b, strain CPV-2b Bio 12/B, Live
    6.60
    log10 tissue culture infective dose 50
    /
    1.00
    Dose
  • Canine parainfluenza virus 2, strain CPiV-2-Bio 15, Live
    5.10
    log10 tissue culture infective dose 50
    /
    1.00
    Dose
  • Leptospira interrogans, serogroup Icterohaemorrhagiae, serovar Icterohaemorrhagiae, strain MSLB 1089, Inactivated
    51.00
    Antibody microagglutination-lytic reaction
    /
    1.00
    Dose
  • Leptospira interrogans, serogroup Canicola, serovar Canicola, strain MSLB 1090, Inactivated
    51.00
    Antibody microagglutination-lytic reaction
    /
    1.00
    Dose
  • Rabies virus, strain SAD Vnukovo-32, Inactivated
    2.00
    international unit(s)
    /
    1.00
    Dose
  • Leptospira interrogans, serogroup Australis, serovar Bratislava, Inactivated
    51.00
    Antibody microagglutination-lytic reaction
    /
    1.00
    Dose
  • Leptospira kirschneri, Serogroup Grippotyphosa, Inactivated
    40.00
    Antibody microagglutination-lytic reaction
    /
    1.00
    Dose
Pharmaceutical form:
  • Lyophilisate and solvent for suspension for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI07AJ06
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Romania
Package description:
  • Glass Vial 50 x 1.0 Dose
  • Glass Vial 25 x 1.0 Dose
  • Glass Vial 10 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:
  • 190281
Date of authorisation status change:
Reference member state:
  • Czechia
Procedure number:
  • CZ/V/0119/001
Concerned member states:
  • Bulgaria
  • Croatia
  • Cyprus
  • Estonia
  • Hungary
  • Latvia
  • Lithuania
  • Poland
  • Romania
  • Slovakia
  • Slovenia

Documents

Summary of Product Characteristics

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Romanian (PDF)
Published on: 31/07/2023
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