Veterinary Medicines

Fencovis

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
Download as PDF

Product identification

Medicine name:
Fencovis, Suspension for injection
Fencovis
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:
  • Ireland
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:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA10454/080/001
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
Download

Package Leaflet

English (PDF)
Published on: 25/08/2022
Download

Labelling

English (PDF)
Published on: 25/08/2022
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."