Veterinary Medicines

Rotavak vakcina A.U.V.

Authorised
  • Bovine rotavirus A, type G6P1, strain TM-91, Inactivated
  • Bovine coronavirus, strain C-197, Inactivated
  • Escherichia coli, fimbrial adhesin F5
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Product identification

Medicine name:
Rotavak vakcina A.U.V.
Active substance:
  • Bovine rotavirus A, type G6P1, strain TM-91, Inactivated
  • Bovine coronavirus, strain C-197, Inactivated
  • Escherichia coli, fimbrial adhesin F5
Target species:
  • Cattle
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Bovine rotavirus A, type G6P1, strain TM-91, Inactivated
    6.00
    log2 virus neutralising unit(s)
    /
    1.00
    unit(s)/dose
  • Bovine coronavirus, strain C-197, Inactivated
    5.00
    haemagglutination inhibiting unit(s)
    /
    1.00
    unit(s)/dose
  • Escherichia coli, fimbrial adhesin F5
    45.00
    enzyme-linked immunosorbent assay unit
    /
    1.00
    unit(s)/dose
Pharmaceutical form:
  • Emulsion for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        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:
  • Hungary
Package description:

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:
  • Fortevit Kft.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Pharmagal Bio spol. s r.o.
Responsible authority:
  • Directorate Of Veterinary Medicinal Products
Authorisation number:
This information is not available for this product.
Date of authorisation status change:

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Hungarian (PDF)
Published on: 1/03/2024
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Package Leaflet

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Hungarian (PDF)
Published on: 1/03/2024
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Hungarian (PDF)
Published on: 1/03/2024
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