Versican Plus DP lyophilisate and solvent for suspension for injection for dogs

Authorised

Canine parvovirus 2b, strain CPV-2b Bio 12/B, Live
Canine distemper virus, strain CDV Bio 11/A, Live

Product identification

Medicine name:

Versican Plus DP Liofilizat (żywy, atenuowany):-Wirus nosówki psów, szczep CDV Bio 11/A ≥10^3,1 TCID50*, ≤10^5,1 TCID50,-Parwowirus psów, typ 2b, szczep CPV-2b-Bio 12/B ≥10^4,3 TCID50*, ≤10^6,6 TCID50.(*) Dawka zakaźna dla 50 % hodowli tkankowych Liofilizat i rozpuszczalnik do sporządzania zawiesiny do wstrzykiwań

Active substance:

Canine parvovirus 2b, strain CPV-2b Bio 12/B, Live
Canine distemper virus, strain CDV Bio 11/A, Live

Target species:

Route of administration:

Subcutaneous use

Product details

Active substance and strength:

Canine parvovirus 2b, strain CPV-2b Bio 12/B, Live

19953.00

tissue culture infective dose 50

/

1.00

Dose
Canine distemper virus, strain CDV Bio 11/A, Live

1259.00

tissue culture infective dose 50

/

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:

QI07AD03

Legal status of supply:

Veterinary medicinal product subject to veterinary prescription

Authorisation status:

Valid

Authorised in:

Poland

Available in:

Poland

Package description:

(ID2): 1 Box with 50 Vial (Glass) with 1 Dose and 50 Vial (Glass) with 1 ml (50.0 Dose, 50.0 ml)
(ID1): 1 Box with 25 Vial (Glass) with 1 Dose and 25 Vial (Glass) with 1 ml (25.0 Dose, 25.0 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 Polska Sp. z o.o.

Marketing authorisation date:

31/10/2016

Manufacturing sites for batch release:

Bioveta a.s.

Responsible authority:

Office For Registration Of Medicinal Products Medical Devices And Biocidal Products

Authorisation number:

2570

Date of authorisation status change:

31/10/2016

Reference member state:

Germany

Procedure number:

DE/V/0266/001

Concerned member states:

Belgium
Bulgaria
Cyprus
Greece
Hungary
Italy
Lithuania
Luxembourg
Malta
Netherlands
Poland
Portugal
Romania
Spain
United Kingdom (Northern Ireland)

To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet

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