Veterinary Medicines

KOLIBIN RC NEO injekčná emulzia pre hovädzí dobytok

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

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

Product details

Active substance and strength:
  • Bovine rotavirus, strain TM-91, Inactivated
  • Bovine coronavirus, strain C-197, Inactivated
    5.00
    log2 haemagglutination inhibiting unit(s)
    /
    2.00
    millilitre(s)
  • Escherichia coli, serotype O101:K30 (fimbrial adhesin F5), Inactivated
    1.00
    relative potency
    /
    2.00
    millilitre(s)
  • Escherichia coli, serotype O8:K35 (fimbrial adhesin F5), Inactivated
    1.00
    relative potency
    /
    2.00
    millilitre(s)
  • Escherichia coli, serotype O9:K35, Inactivated
    1.00
    relative potency
    /
    2.00
    millilitre(s)
Pharmaceutical form:
  • Emulsion for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle (pregnant cow)
      • All relevant tissues
        0
        day
    • Cattle (pregnant heifer)
      • All relevant tissues
        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:
  • Slovakia
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:
  • 97/045/07-S
Date of authorisation status change:

Documents

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Published on: 7/01/2022
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