Veterinary Medicines

Bovilis Rotavec Corona Emulsion for Injection for Cattle

Authorised
  • Escherichia coli, serotype O101:K99 (fimbrial adhesins F5 and F41), strain CN7985, Inactivated
  • Bovine coronavirus, strain Mebus, Inactivated
  • Bovine rotavirus A, type G6P5, strain UK-Compton, Inactivated
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Product identification

Medicine name:
Bovilis Rotavec Corona Emulsion for Injection for Cattle
Bovilis Rotavec Corona vet. injeksjonsvæske, emulsjon til storfe
Active substance:
  • Escherichia coli, serotype O101:K99 (fimbrial adhesins F5 and F41), strain CN7985, Inactivated
  • Bovine coronavirus, strain Mebus, Inactivated
  • Bovine rotavirus A, type G6P5, strain UK-Compton, Inactivated
Target species:
  • Cattle
Route of administration:
  • Intramuscular use
  • Subcutaneous use

Product details

Active substance and strength:
  • Escherichia coli, serotype O101:K99 (fimbrial adhesins F5 and F41), strain CN7985, Inactivated
    560.00
    enzyme-linked immunosorbent assay unit
    /
    2.00
    millilitre(s)
  • Bovine coronavirus, strain Mebus, Inactivated
    340.00
    enzyme-linked immunosorbent assay unit
    /
    2.00
    millilitre(s)
  • Bovine rotavirus A, type G6P5, strain UK-Compton, Inactivated
    874.00
    enzyme-linked immunosorbent assay unit
    /
    2.00
    millilitre(s)
Pharmaceutical form:
  • Emulsion for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        0
        day
  • Subcutaneous 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:
  • Norway
Package description:
  • (ID3) 40 millilitre(s): Box (Cardboard) with 1 Vial (Glass) with 40 millilitre(s)
  • (ID4) 100 millilitre(s): Box (Cardboard) with 1 Vial (Glass) with 100 millilitre(s)
  • (ID2) 10 millilitre(s): Box (Cardboard) with 1 Vial (Glass) with 10 millilitre(s)
  • (ID1) 20 millilitre(s): Box (Cardboard) with 10 Vial (Glass) each with 2 millilitre(s)
  • (ID5) 10 millilitre(s): Box (Cardboard) with 1 Vial (PolyEthylene TerePhthalate) with 10 millilitre(s)
  • (ID6) 40 millilitre(s): Box (Cardboard) with 1 Vial (PolyEthylene TerePhthalate) with 40 millilitre(s)
  • (ID7) 100 millilitre(s): Box (Cardboard) with 1 Vial (PolyEthylene TerePhthalate) with 100 millilitre(s)

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Immunological veterinary medicinal product application (Article 13d of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Intervet International B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Burgwedel Biotech GmbH
  • Intervet International B.V.
Responsible authority:
  • Norwegian Medical Products Agency
Authorisation number:
  • 20-13257
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0276/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Malta
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 28/01/2022
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Norwegian (PDF)
Published on: 31/01/2022
Download

Combined File of all Documents

English (PDF)
Published on: 3/01/2025
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