Veterinary Medicines

ROTAGAL emulsion for injection

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

Product identification

Medicine name:
ROTAGAL emulsion for injection
ROTAGAL, Injekční emulze
Active substance:
  • Escherichia coli, fimbrial adhesin F5
  • Bovine coronavirus, strain C-197, Inactivated
  • Bovine rotavirus A, type G6P1, strain TM-91, Inactivated
Target species:
  • Cattle (pregnant cow)
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Escherichia coli, fimbrial adhesin F5
    39.70
    enzyme-linked immunosorbent assay unit
    /
    3.00
    millilitre(s)
  • Bovine coronavirus, strain C-197, Inactivated
    44.80
    enzyme-linked immunosorbent assay unit
    /
    3.00
    millilitre(s)
  • Bovine rotavirus A, type G6P1, strain TM-91, Inactivated
    32.10
    enzyme-linked immunosorbent assay unit
    /
    3.00
    millilitre(s)
Pharmaceutical form:
  • Emulsion for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle (pregnant cow)
      • 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:
  • 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:
  • Pharmagal Bio spol. s r.o.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Pharmagal Bio spol. s r.o.
Responsible authority:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 97/041/08/C
Date of authorisation status change:
Reference member state:
  • Slovakia
Procedure number:
  • SK/V/0105/001
Concerned member states:
  • Czechia

Documents

Combined File of all Documents

English (PDF)
Published on: 24/01/2022
Download

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 25/10/2022
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 25/10/2022
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 25/10/2022
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."