BioEquin FH, Emulsion for injection
BioEquin FH, Emulsion for injection
Authorised
- Equine influenza virus H3N8, A/Equi 2/Brno/08, Inactivated
- Equine Influenza virus H3N8, A/Equi 2/Limerick 2010, Inactivated
- Equine herpesvirus 1, Inactivated
Product identification
Medicine name:
BioEquin FH, Emulsion for injection
BIOEQUIN FH, emulsie injectabilă pentru cai
Active substance:
- Equine influenza virus H3N8, A/Equi 2/Brno/08, Inactivated
- Equine Influenza virus H3N8, A/Equi 2/Limerick 2010, Inactivated
- Equine herpesvirus 1, Inactivated
Target species:
-
Horse
Route of administration:
-
Intramuscular use
Product details
Active substance and strength:
-
Equine influenza virus H3N8, A/Equi 2/Brno/08, Inactivated6.00log2 haemagglutination inhibiting unit(s)1.00Dose
-
Equine Influenza virus H3N8, A/Equi 2/Limerick 2010, Inactivated6.00log2 haemagglutination inhibiting unit(s)1.00Dose
-
Equine herpesvirus 1, Inactivated2.10log10 virus neutralising unit(s)1.00Dose
Pharmaceutical form:
-
Emulsion for injection
Withdrawal period by route of administration:
-
Intramuscular use
- Horse
-
Meat0day
-
Milk0hour
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QI05AA04
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Romania
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:
- Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
- 180051
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
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.
Romanian (PDF)
Published on: 5/04/2023
Combined File of all Documents
English (PDF)
Download Published on: 5/09/2022
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