1-NAMEANDADDRESS OF THE MARKETINGAUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER
Marketing authorisation holder:
Bioveta, a.s.,Komenského 212/12,Ivanovice na Hané,683 23, Czech Republic
Manufacturer responsible for batch release:
Bioveta, a.s.,Komenského 212,Ivanovice na Hané,683 23, Czech Republic
2-NAME OF THE VETERINARY MEDICINALPRODUCT
Biocan Novel DHPPi/L4, lyophilisateand solvent for suspension for injectionfor dogs.
3.STATEMENT OF THEACTIVE SUBSTANCE(S)AND OTHER INGREDIENT(S)
Composition per 1 ml dose:
Active substances:Lyophilisate (live attenuated):

Minimum                                                               Maximum
Canine Distemper virus,
strain CDV Bio 11/A10^3.1TCID₅₀                              10^5.1TCID₅₀

CanineAdenovirusType 2,strain CAV-2 Bio 13
10^3.6TCID*                                                                10^5.3TCID₅₀*

Canine ParvovirusType 2b,strain CPV-2b Bio 12/B
10^4.3TCID*                                                                10^6.6TCID₅₀*

Canine ParainfluenzaType 2virus,strain CPiV-2 Bio 15
10^3.1TCID₅₀*                                                             10^5.1TCID₅₀*

Solvent (inactivated):
Leptospira interrogans
serogroup Icterohaemorrhagiaeserovar Icterohaemorrhagiae,
strain MSLB 1089GMT**≥1:51ALR***