Veterinary Medicines

Rotavak vakcina A.U.V.

Authorised
  • Bovine rotavirus, strain TM-91, Inactivated
  • Bovine coronavirus, strain C-197, Inactivated
  • Escherichia coli, fimbrial adhesin F5
Download as PDF

Product identification

Medicine name:
Rotavak vakcina A.U.V.
Active substance:
  • Bovine rotavirus, 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, 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
Download

Package Leaflet

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

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
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."