Veterinary Medicines

Fencovis, Suspension for injection

Authorised
  • Escherichia coli, serotype O8:K35 (fimbrial adhesin F5), Inactivated
  • Bovine coronavirus, strain C-197, Inactivated
  • Bovine rotavirus A, type G6P1, strain TM-91, Inactivated
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Product identification

Medicine name:
Fencovis, Injekční suspenze
Fencovis, Suspension for injection
Active substance:
  • Escherichia coli, serotype O8:K35 (fimbrial adhesin F5), Inactivated
  • Bovine coronavirus, strain C-197, Inactivated
  • Bovine rotavirus A, type G6P1, strain TM-91, Inactivated
Target species:
  • Cattle
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Escherichia coli, serotype O8:K35 (fimbrial adhesin F5), Inactivated
    1.00
    relative potency
    /
    1.00
    Dose
  • Bovine coronavirus, strain C-197, Inactivated
    1.00
    relative potency
    /
    1.00
    Dose
  • Bovine rotavirus A, type G6P1, strain TM-91, Inactivated
    1.00
    relative potency
    /
    1.00
    Dose
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        0
        hour
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI02AL01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Czechia
Package description:
  • Glass Vial 2 x 1.0 Dose
  • Glass Vial 10 x 1.0 Dose
  • Glass Vial 20 x 1.0 Dose
  • Glass Vial 1 x 5.0 Dose
  • Plastic Vial 1 x 5.0 Dose
  • Glass Vial 5 x 5.0 Dose
  • Plastic Vial 5 x 5.0 Dose
  • Glass Vial 10 x 5.0 Dose
  • Plastic Vial 10 x 5.0 Dose
  • Glass Vial 1 x 25.0 Dose
  • Plastic Vial 1 x 25.0 Dose
  • Glass Vial 12 x 25.0 Dose
  • Plastic Vial 12 x 25.0 Dose
  • Glass Vial 24 x 25.0 Dose
  • Plastic Vial 24 x 25.0 Dose
  • Glass Vial 1 x 50.0 Dose
  • Plastic Vial 1 x 50.0 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:
  • Boehringer Ingelheim Vetmedica GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Bioveta a.s.
Responsible authority:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 97/015/22-C
Date of authorisation status change:
Reference member state:
  • Czechia
Procedure number:
  • CZ/V/0177/001
Concerned member states:
  • Austria
  • Belgium
  • Finland
  • France
  • Germany
  • Greece
  • Ireland
  • Italy
  • Luxembourg
  • Netherlands
  • Norway
  • Portugal
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 25/08/2022
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Czech (PDF)
Published on: 6/01/2025
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Labelling

English (PDF)
Published on: 25/08/2022
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Czech (PDF)
Published on: 6/01/2025
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Package Leaflet

English (PDF)
Published on: 25/08/2022
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Czech (PDF)
Published on: 6/01/2025
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eu-puar-czv0177001-mr-fencovis-en.pdf

English (PDF)
Published on: 16/11/2023
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