Veterinary Medicines

KOLIBIN RC NEO, Injekční emulze

Authorised
  • Bovine coronavirus, strain C-197, Inactivated
  • Bovine rotavirus A, type G6P1, strain TM-91, Inactivated
  • Escherichia coli, serotype O8:K35 (fimbrial adhesin F5), Inactivated
  • Escherichia coli, serotype O9:K35 (fimbrial adhesin F5), Inactivated
  • Escherichia coli, serotype O101:K30 (fimbrial adhesin F5), Inactivated
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Product identification

Medicine name:
KOLIBIN RC NEO, Injekční emulze
Active substance:
  • Bovine coronavirus, strain C-197, Inactivated
  • Bovine rotavirus A, type G6P1, strain TM-91, Inactivated
  • Escherichia coli, serotype O8:K35 (fimbrial adhesin F5), Inactivated
  • Escherichia coli, serotype O9:K35 (fimbrial adhesin F5), Inactivated
  • Escherichia coli, serotype O101:K30 (fimbrial adhesin F5), Inactivated
Target species:
  • Cattle (cow)
  • Cattle (pregnant heifer)
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • 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
  • Escherichia coli, serotype O8:K35 (fimbrial adhesin F5), Inactivated
    1.00
    relative potency
    /
    1.00
    Dose
  • Escherichia coli, serotype O9:K35 (fimbrial adhesin F5), Inactivated
    1.00
    relative potency
    /
    1.00
    Dose
  • Escherichia coli, serotype O101:K30 (fimbrial adhesin F5), Inactivated
    1.00
    relative potency
    /
    1.00
    Dose
Pharmaceutical form:
  • Emulsion for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle (cow)
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Cattle (pregnant heifer)
      • 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:

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 State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 97/029/05-C
Date of authorisation status change:

Documents

Summary of Product Characteristics

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Czech (PDF)
Published on: 27/01/2025
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Package Leaflet

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Czech (PDF)
Published on: 27/01/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 27/01/2025
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