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
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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
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Summary of Product Characteristics

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Czech (PDF)
Published on: 25/10/2022
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Package Leaflet

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Czech (PDF)
Published on: 25/10/2022
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Labelling

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Czech (PDF)
Published on: 25/10/2022
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