RISPOVAL 3 BRSV PI3 BVD LYOPHILISATE AND SUSPENSION FOR SUSPENSION FOR INJECTION FOR CATTLE
RISPOVAL 3 BRSV PI3 BVD LYOPHILISATE AND SUSPENSION FOR SUSPENSION FOR INJECTION FOR CATTLE
Authorised
- Bovine parainfluenza virus 3, strain RLB103, Live
- Bovine viral diarrhoea virus 1, strain 5960, Inactivated
- Bovine viral diarrhoea virus 1, strain 6309, Inactivated
- Bovine respiratory syncytial virus, strain 375, Live
Product identification
Medicine name:
RISPOVAL 3 BRSV PI3 BVD LYOPHILISATE AND SUSPENSION FOR SUSPENSION FOR INJECTION FOR CATTLE
RISPOVAL 3 RS PI3 BVD LYOPHILISAT ET SUSPENSION POUR SUSPENSION INJECTABLE POUR BOVINS
Active substance:
- Bovine parainfluenza virus 3, strain RLB103, Live
- Bovine viral diarrhoea virus 1, strain 5960, Inactivated
- Bovine viral diarrhoea virus 1, strain 6309, Inactivated
- Bovine respiratory syncytial virus, strain 375, Live
Target species:
-
Cattle
Route of administration:
-
Intramuscular use
Product details
Active substance and strength:
-
Bovine parainfluenza virus 3, strain RLB103, Live100000.00cell culture infective dose 501.00unit(s)
-
Bovine viral diarrhoea virus 1, strain 5960, Inactivated3.00log2 serum neutralising unit(s)1.00unit(s)
-
Bovine viral diarrhoea virus 1, strain 6309, Inactivated3.00log2 serum neutralising unit(s)1.00unit(s)
-
Bovine respiratory syncytial virus, strain 375, Live100000.00cell culture infective dose 501.00unit(s)
Pharmaceutical form:
-
Lyophilisate and suspension for suspension for injection
Withdrawal period by route of administration:
-
Intramuscular use
- Cattle
-
All relevant tissues0day
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QI02AH
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
France
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Full application - New active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
- Zoetis France
Marketing authorisation date:
Manufacturing sites for batch release:
- Zoetis Belgium
Responsible authority:
- French Agency For Food, Environmental And Occupational Health & Safety
Authorisation number:
- FR/V/1611855 9/2003
Date of authorisation status change:
Reference member state:
-
France
Procedure number:
- FR/V/0146/001
Concerned member states:
-
Belgium
-
Bulgaria
-
Czechia
-
Estonia
-
Germany
-
Hungary
-
Ireland
-
Latvia
-
Lithuania
-
Luxembourg
-
Netherlands
-
Poland
-
Portugal
-
Romania
-
Slovakia
-
Slovenia
-
Spain
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 22/05/2024
Combined File of all Documents
English (PDF)
Download Published on: 24/01/2024
Package Leaflet and Labelling
This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 22/05/2024
How useful was this page?: