Versican Plus DHPPi/L4 (--) - Lyophilisate and suspension for suspension for injection
Versican Plus DHPPi/L4 (--) - Lyophilisate and suspension for suspension for injection
Authorised
- Canine distemper virus, strain CDVU 39, 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 Australis, serovar Bratislava, strain MSLB 1088, Inactivated
- Leptospira interrogans, serogroup Canicola, serovar Canicola, strain MSLB 1090, Inactivated
- Leptospira kirschneri, serogroup Grippotyphosa, serovar Grippotyphosa, strain MSLB 1091, Inactivated
Product identification
Medicine name:
Versican Plus DHPPi/L4 (--) - Lyophilisate and suspension for suspension for injection
Active substance:
- Canine distemper virus, strain CDVU 39, 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 Australis, serovar Bratislava, strain MSLB 1088, Inactivated
- Leptospira interrogans, serogroup Canicola, serovar Canicola, strain MSLB 1090, 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 distemper virus, strain CDVU 39, LivePresentation_strength:10³·¹ - 10⁵·¹ TCID₅₀ Reference:Ph Eur 0448 Comments:Lyophilisate Index:0
-
Canine adenovirus 2, strain CAV-2-Bio 13, LivePresentation_strength:10³·⁶ - 10⁵·³ TCID₅₀ Reference:Ph Eur 1951 Comments:Lyophilisate Index:1
-
Canine parvovirus 2b, strain CPV-2b Bio 12/B, LivePresentation_strength:10⁴·³ - 10⁶·⁶ TCID₅₀ Reference:Ph Eur 0964 Comments:Lyophilisate Index:2
-
Canine parainfluenza virus 2, strain CPiV-2-Bio 15, LivePresentation_strength:10³·¹ - 10⁵·¹ TCID₅₀1 Reference:Ph Eur 1955 Comments:Lyophilisate Index:3
-
Leptospira interrogans, serogroup Icterohaemorrhagiae, serovar Icterohaemorrhagiae, strain MSLB 1089, InactivatedPresentation_strength:≥1:51 ALR Reference:Ph Eur 0447 Comments:Suspension Index:4
-
Leptospira interrogans, serogroup Australis, serovar Bratislava, strain MSLB 1088, InactivatedPresentation_strength:≥1:51 ALR Reference:Ph Eur 0447 Comments:Suspension Index:5
-
Leptospira interrogans, serogroup Canicola, serovar Canicola, strain MSLB 1090, InactivatedPresentation_strength:≥1:51 ALR Reference:Ph Eur 0447 Comments:Suspension Index:6
-
Leptospira kirschneri, serogroup Grippotyphosa, serovar Grippotyphosa, strain MSLB 1091, InactivatedPresentation_strength:≥1:40 ALR Reference:Ph Eur 0447 Comments:Suspension Index:7
Pharmaceutical form:
-
Lyophilisate and suspension 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:
-
Austria
-
Belgium
-
Bulgaria
-
Croatia
-
Cyprus
-
Czechia
-
Denmark
-
Estonia
-
Finland
-
France
-
Germany
-
Greece
-
Hungary
-
Iceland
-
Ireland
-
Italy
-
Latvia
-
Liechtenstein
-
Lithuania
-
Luxembourg
-
Malta
-
Netherlands
-
Norway
-
Poland
-
Portugal
-
Romania
-
Slovakia
-
Slovenia
-
Spain
-
Sweden
-
United Kingdom (Northern Ireland)
Package description:
- Packaging:Lyophilisate: vial (glass); suspension: vial (glass), Package_size:Lyophilisate: 50 vials + suspension: 50 vials, Content:Lyophilisate: 1 dose + suspension: 1 ml
- Packaging:Lyophilisate: vial (glass); suspension: vial (glass), Package_size:Lyophilisate: 25 vials + suspension: 25 vials, Content:Lyophilisate: 1 dose + suspension: 1 ml
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Immunological veterinary medicinal product application (Article 13d of Directive No 2001/82/EC)
Marketing authorisation holder:
- Zoetis Belgium
Marketing authorisation date:
Manufacturing sites for batch release:
- Bioveta a.s.
Responsible authority:
- European Commission
Authorisation number:
This information is not available for this product.
Date of authorisation status change:
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Combined File of all Documents
English (PDF)
Download Published on: 1/09/2023
Bulgarian (PDF)
Published on: 1/09/2023
Croatian (PDF)
Published on: 1/09/2023
Czech (PDF)
Published on: 1/09/2023
Danish (PDF)
Published on: 1/09/2023
Dutch (PDF)
Published on: 1/09/2023
Estonian (PDF)
Published on: 1/09/2023
Finnish (PDF)
Published on: 1/09/2023
French (PDF)
Published on: 1/09/2023
German (PDF)
Published on: 1/09/2023
Greek (PDF)
Published on: 1/09/2023
Hungarian (PDF)
Published on: 1/09/2023
Icelandic (PDF)
Published on: 1/09/2023
Italian (PDF)
Published on: 1/09/2023
Latvian (PDF)
Published on: 1/09/2023
Lithuanian (PDF)
Published on: 1/09/2023
Maltese (PDF)
Published on: 1/09/2023
Norwegian (PDF)
Published on: 1/09/2023
Polish (PDF)
Published on: 1/09/2023
Portuguese (PDF)
Published on: 1/09/2023
Romanian (PDF)
Published on: 1/09/2023
Slovak (PDF)
Published on: 1/09/2023
Slovenian (PDF)
Published on: 1/09/2023
Spanish (PDF)
Published on: 1/09/2023
Swedish (PDF)
Published on: 1/09/2023
ema-puar-versican-plus-dhppi-l4-v-3678-par-en.pdf
English (PDF)
Download Published on: 16/03/2023
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