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Versican Plus Pi/L4R

Canine parainfluenza virus (live attenuated), canine leptospirosis and rabies (inactivated) vaccine

Opinion

On 13 September 2018, the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a positive opinion1, recommending the granting of a variation to the terms of the marketing authorisations for the veterinary medicinal products Versican Plus DHPPi/L4R, Versican Plus DHPPi/L4, Versican Plus DHPPi, Versican Plus Pi/L4R, Versican Plus Pi/L4, Versican Plus Pi and Versican Plus L4. The marketing authorisation holder for these veterinary medicinal products is Zoetis Belgium S.A.

Versican Plus DHPPi/L4R, Versican Plus DHPPi/L4, Versican Plus Pi/L4R, Versican Plus Pi/L4 and Versican Plus Pi are currently authorised as lyophilisate and suspension for suspension for injection. Versican Plus DHPPi and Versican Plus Pi are currently authorised as lyophilisate and solvent for suspension for injection.Versican Plus L4 is currently authorised as suspension for injection. The variation concerns the inclusion of data regarding the use of Versican Plus range vaccines during pregnancy. The variation introduces changes to the summary of product characteristics (SPC) and other product information. The product information has been simultaneously aligned with the latest quality review of documents (QRD) template v.8.1.

Detailed conditions for the use of these products are described in the updated summary of product characteristics (SPC), for which updated versions reflecting the changes will be published in the revised European public assessment reports (EPAR) and will be available in all official European Union languages after the variation to the marketing authorisations has been granted by the European Commission.


1Applicants may appeal any CVMP opinion, provided they notify the European Medicines Agency in writing of their intention to appeal within 15 days of receipt of the opinion.

Key facts

Name
Versican Plus Pi/L4R
International non-proprietary name (INN) or common name
  • Canine parainfluenza virus (live attenuated), canine leptospirosis and rabies (inactivated) vaccine
Species
Dogs
Active substance
  • Canine parainfluenza type 2 virus, strain CPiV-2 Bio 15 (live attenuated), Leptospira interrogans serogroup Australis serovar Bratislava, strain MSLB 1088, L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae, strain MSLB 1089, L. interrogans serogroup Canicola serovar Canicola, strain MSLB 1090, L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa, strain MSLB 1091 and rabies virus, strain SAD Vnukovo-32 (all inactivated)
Date opinion adopted
13/09/2018
Company name
Zoetis Belgium S.A.
Status
Positive
Application type
Post-authorisation

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