Veterinary Medicines

BOVIGEN SCOUR Emulsion for injection for cattle

Authorised
  • Bovine coronavirus, strain C-197, Inactivated
  • Bovine rotavirus A, type G6P1, strain TM-91, Inactivated
  • Escherichia coli, serotype O9:K35 (fimbrial adhesin F5), strain EC/17, Inactivated
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Product identification

Medicine name:
BOVIGEN SCOUR Emulsion for injection for cattle
Bovigen RCE vet. Injektionsvätska, emulsion
Active substance:
  • Bovine coronavirus, strain C-197, Inactivated
  • Bovine rotavirus A, type G6P1, strain TM-91, Inactivated
  • Escherichia coli, serotype O9:K35 (fimbrial adhesin F5), strain EC/17, Inactivated
Target species:
  • Cattle
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Bovine coronavirus, strain C-197, Inactivated
    5.00
    log2 haemagglutination inhibiting unit(s)
    /
    1.00
    Dose
  • Bovine rotavirus A, type G6P1, strain TM-91, Inactivated
    6.00
    log2 virus neutralising unit(s)
    /
    1.00
    Dose
  • Escherichia coli, serotype O9:K35 (fimbrial adhesin F5), strain EC/17, Inactivated
    44.80
    enzyme-linked immunosorbent assay unit
    /
    1.00
    Dose
Pharmaceutical form:
  • Emulsion for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI02AL01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Sweden
Available in:
  • Sweden
Package description:
  • Glass bottle, type I (450 ml) closed with bromobutyl rubber stoppers sealed with aluminium caps.Package size:Cardboard box with 1 glass bottle of 450 ml (150 doses), type I (450 ml) closed with bromobutyl rubber stoppers sealed with aluminium caps.
  • Glass vials, type I (90 ml) closed with chlorobutyl rubber stoppers.Package size:Cardboard box with 1 vial of 90 ml (30 doses), type I (90 ml) closed with chlorobutyl rubber stoppers
  • Glass vials, type I (15 ml) closed with chlorobutyl rubber stoppers.Package size:Cardboard box with 1 vial of 15 ml (5 doses), type I (15 ml) closed with chlorobutyl rubber stoppers
  • Glass bottle, type I (450 ml) closed with bromobutyl rubber stoppers sealed with aluminium caps.Package size:Plastic bottle with 450 ml (150 doses) closed with chlorobutyl rubber stoppers and sealed with aluminium caps without outer package

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:
  • Forte Healthcare Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Pharmagal Bio spol. s r.o.
Responsible authority:
  • Swedish Medical Products Agency
Authorisation number:
  • 52898
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0341/001
Concerned member states:
  • Austria
  • Belgium
  • Croatia
  • Cyprus
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Malta
  • Netherlands
  • Norway
  • Portugal
  • Romania
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 11/02/2022
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Swedish (PDF)
Published on: 31/01/2024
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Swedish (PDF)
Published on: 29/01/2024
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