Veterinary Medicines

ROTAGAL BG Emulsion for injection for cattle (pregnant cows and heifers)

Authorised
  • Escherichia coli, serotype O9:K35 (fimbrial adhesins F5 and F41), strain EC/17, Inactivated
  • Bovine coronavirus, strain C-197, Inactivated
  • Bovine rotavirus A, type G6P1, strain TM-91, Inactivated
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Product identification

Medicine name:
РОТАГАЛ БГ Инжекционна емулсия за говеда (бременни крави и юници)
ROTAGAL BG Emulsion for injection for cattle (pregnant cows and heifers)
Active substance:
  • Escherichia coli, serotype O9:K35 (fimbrial adhesins F5 and F41), strain EC/17, Inactivated
  • Bovine coronavirus, strain C-197, Inactivated
  • Bovine rotavirus A, type G6P1, strain TM-91, Inactivated
Target species:
  • Cattle
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Escherichia coli, serotype O9:K35 (fimbrial adhesins F5 and F41), strain EC/17, Inactivated
    45.20
    enzyme-linked immunosorbent assay unit
    /
    1.00
    Dose
  • Bovine coronavirus, strain C-197, Inactivated
  • Bovine rotavirus A, type G6P1, strain TM-91, Inactivated
    6.00
    log2 virus neutralising unit(s)
    /
    1.00
    Dose
Pharmaceutical form:
  • Emulsion for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI02AL01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Bulgaria
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Informed consent application (Article 13c of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Vet Pro Komers OOD
Marketing authorisation date:
Manufacturing sites for batch release:
  • Pharmagal Bio spol. s r.o.
Responsible authority:
  • Bulgarian Food Safety Authority
Authorisation number:
  • 0022-2511
Date of authorisation status change:

Documents

Summary of Product Characteristics

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Bulgarian (PDF)
Published on: 20/03/2025
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Package Leaflet

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Bulgarian (PDF)
Published on: 20/03/2025
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Labelling

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Bulgarian (PDF)
Published on: 20/03/2025
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