Veterinary Medicines

BioEquin FH, Emulsion for injection

Authorised
  • Influenza A virus, subtype H3N8, strain A/equine/Brno/08, Inactivated
  • Influenza A virus, subtype H3N8, strain A/equine/Limerick/2010, Inactivated
  • Equine herpesvirus 1, Inactivated
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Product identification

Medicine name:
BioEquin FH, Emulsion for injection
BioEquin FH, emulzija za injiciranje za konje
Active substance:
  • Influenza A virus, subtype H3N8, strain A/equine/Brno/08, Inactivated
  • Influenza A virus, subtype H3N8, strain A/equine/Limerick/2010, Inactivated
  • Equine herpesvirus 1, 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
    6.00
    log2 haemagglutination inhibiting unit(s)
    /
    1.00
    Dose
  • Influenza A virus, subtype H3N8, strain A/equine/Limerick/2010, Inactivated
    6.00
    log2 haemagglutination inhibiting unit(s)
    /
    1.00
    Dose
  • Equine herpesvirus 1, Inactivated
    2.10
    log10 virus neutralising unit(s)
    /
    1.00
    Dose
Pharmaceutical form:
  • Emulsion for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Horse
      • Meat
        0
        day
      • Milk
        0
        hour
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI05AA04
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Slovenia
Package description:
  • Glass Vial
  • Glass Vial
  • Glass Vial
  • Glass Vial
  • Glass Vial

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:
  • Agency For Medicinal Products And Medical Devices Of The Republic Of Slovenia
Authorisation number:
  • MR/V/0485/001
Date of authorisation status change:
Reference member state:
  • Czechia
Procedure number:
  • CZ/V/0127/001
Concerned member states:
  • Estonia
  • Hungary
  • Latvia
  • Lithuania
  • Poland
  • Romania
  • Slovakia
  • Slovenia

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 2/03/2022
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 2/03/2022
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 2/03/2022
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Combined File of all Documents

English (PDF)
Published on: 5/09/2022
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