Veterinary Medicines

BioEquin FT suspension for injection for horses

Authorised
  • Influenza A virus, subtype H3N8, strain A/equine/Brno/08, Inactivated
  • Clostridium tetani, toxoid
  • Influenza A virus, subtype H3N8, strain A/equine/Limerick/2010, Inactivated
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Product identification

Medicine name:
BioEquin FT suspension for injection for horses
BIOEQUIN FT SUSPENSION INYECTABLE PARA CABALLOS
Active substance:
  • Influenza A virus, subtype H3N8, strain A/equine/Brno/08, Inactivated
  • Clostridium tetani, toxoid
  • 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, Inactivated
    5.00
    log2 haemagglutination inhibiting unit(s)
    /
    1.00
    Dose
  • Clostridium tetani, toxoid
    30.00
    international unit(s)
    /
    1.00
    Dose
  • Influenza A virus, subtype H3N8, strain A/equine/Limerick/2010, Inactivated
    5.00
    log2 haemagglutination inhibiting unit(s)
    /
    1.00
    Dose
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Horse
      • Milk
        0
        hour
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI05AL01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Spain
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:
  • Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 4412 ESP
Date of authorisation status change:
Reference member state:
  • Czechia
Procedure number:
  • CZ/V/0201/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Denmark
  • Finland
  • France
  • Germany
  • Ireland
  • Italy
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)
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