BioEquin F suspension for injection for horses
BioEquin F suspension for injection for horses
Authorised
- Influenza A virus, subtype H3N8, strain A/equine/Brno/08, Inactivated
- Influenza A virus, subtype H3N8, strain A/equine/Limerick/2010, Inactivated
Product identification
Medicine name:
BioEquin F suspension for injection for horses
Active substance:
- Influenza A virus, subtype H3N8, strain A/equine/Brno/08, Inactivated
- Influenza A virus, subtype H3N8, strain A/equine/Limerick/2010, Inactivated
Target species:
-
Horse
Route of administration:
-
Intramuscular use
Product details
Active substance and strength:
-
Influenza A virus, subtype H3N8, strain A/equine/Brno/08, Inactivated5.00/log2 haemagglutination inhibiting unit(s)1.00Dose
-
Influenza A virus, subtype H3N8, strain A/equine/Limerick/2010, Inactivated5.00/log2 haemagglutination inhibiting unit(s)1.00Dose
Pharmaceutical form:
-
Suspension for injection
Withdrawal period by route of administration:
-
Intramuscular use
-
Horse
-
Milk0hour
-
Meat and offal0day
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QI05AA01
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Belgium
Package description:
- glass vial 2 x 1.0 dose
- glass vial 5 x 1.0 dose
- glass vial 10 x 1.0 dose
- glass vial 1 x 5.0 dose
- glass vial 10 x 5.0 dose
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
- Bioveta a.s.
Marketing authorisation date:
Manufacturing sites for batch release:
- Bioveta a.s.
Responsible authority:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V665134
Date of authorisation status change:
Reference member state:
-
Czechia
Procedure number:
- CZ/V/0200/001
Concerned member states:
-
Austria
-
Belgium
-
Denmark
-
Finland
-
France
-
Germany
-
Ireland
-
Italy
-
Latvia
-
Lithuania
-
Netherlands
-
Norway
-
Poland
-
Portugal
-
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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Labelling
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Package Leaflet
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