Bovilis INtranasal RSP Live nasal spray, lyophilisate and solvent for suspension for cattle
Bovilis INtranasal RSP Live nasal spray, lyophilisate and solvent for suspension for cattle
Authorised
- Bovine parainfluenza virus 3, strain INT2-2013, Live
- Bovine respiratory syncytial virus, strain Jencine-2013, Live
Product identification
Medicine name:
Bovilis INtranasal RSP Live nasal spray, lyophilisate and solvent for suspension for cattle
Bovilis INtranasal RSP Live Neusspray, lyofilisaat en oplosmiddel voor suspensie
Bovilis INtranasal RSP Live Lyophilisat et solvant pour suspension pour pulvérisation nasale
Bovilis INtranasal RSP Live Nasenspray, Lyophilisat und Lösungsmittel zur Herstellung einer Suspension
Active substance:
- Bovine parainfluenza virus 3, strain INT2-2013, Live
- Bovine respiratory syncytial virus, strain Jencine-2013, Live
Target species:
-
Cattle
Route of administration:
-
Nasal use
Product details
Active substance and strength:
-
Bovine parainfluenza virus 3, strain INT2-2013, Live4.80/log10 50% tissue culture infectious dose2.00millilitre(s)
-
Bovine respiratory syncytial virus, strain Jencine-2013, Live5.00/log10 50% tissue culture infectious dose2.00millilitre(s)
Pharmaceutical form:
-
Nasal spray, suspension
Withdrawal period by route of administration:
-
Nasal use
-
Cattle
-
Meat and offalno withdrawal periodzero days
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QI02AD07
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Belgium
Available in:
-
Belgium
Package description:
- Cardboard box 5 x 5 doses of lyophilisate and 5 x 10 ml of solvent
- Cardboard box with 20 doses of lyophilisate and cardboard box with 40 ml of solvent
- Cardboard box with 1 dose of lyophilisate and 2 ml of solvent.
- Cardboard box 5 x 1 dose of lyophilisate and 5 x 2 ml of solvent
- Cardboard box 5 doses of lyophilisate and 10 ml of solvent.
- Cardboard box 10 doses of lyophilisate and 20 ml of solvent.
- Cardboard box with 10 doses of lyophilisate and cardboard box with 20 ml solvent
- Cardboard box with 20 doses of lyophilisate and 40 ml of solvent
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
- Intervet International B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
- Intervet International B.V.
Responsible authority:
- Federal Agency For Medicines And Health Products
Authorisation number:
This information is not available for this product.
Date of authorisation status change:
Reference member state:
-
Netherlands
Procedure number:
- NL/V/0257/001
Concerned member states:
-
Austria
-
Belgium
-
Bulgaria
-
Croatia
-
Cyprus
-
Czechia
-
Denmark
-
Estonia
-
Finland
-
France
-
Germany
-
Greece
-
Hungary
-
Iceland
-
Ireland
-
Italy
-
Latvia
-
Lithuania
-
Luxembourg
-
Norway
-
Poland
-
Portugal
-
Romania
-
Slovakia
-
Slovenia
-
Spain
-
Sweden
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
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Package Leaflet
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Combined File of all Documents
English (PDF)
Download Published on: 25/03/2024
Labelling
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