Veterinary Medicines

DiarrVac RCE Emulsion for injection for cattle.

Authorised
  • Bovine rotavirus A, Inactivated
  • Bovine coronavirus, Inactivated
  • Escherichia coli (inactivated)
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Product identification

Medicine name:
DiarrVac RCE Emulsion for injection for cattle.
DiarrVac RCE Emulsion for injection for cattle.
Active substance:
  • Bovine rotavirus A, Inactivated
  • Bovine coronavirus, Inactivated
  • Escherichia coli (inactivated)
Target species:
  • Cattle
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Bovine rotavirus A, Inactivated
    6.00
    log2 virus neutralising unit(s)
    /
    1.00
    Dose
  • Bovine coronavirus, Inactivated
    6.00
    log2 haemagglutination inhibiting unit(s)
    /
    1.00
    Dose
  • Escherichia coli (inactivated)
    44.80
    enzyme-linked immunosorbent assay unit
    /
    1.00
    Dose
Pharmaceutical form:
  • Emulsion for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        0
        hour
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI02AL01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Ireland
Package description:
  • Glass bottle, type I (450 ml) closed with bromobutyl rubber stoppers sealed with aluminium caps. Plastic bottles (450 ml) closed with chlorobutyl rubber stoppers and sealed with aluminium caps without outer package.Cardboard box with 1glass bottle of 450 ml (150 doses). Plastic bottle with 450 ml (150 doses)
  • Glass vial, type I closed with chlorobutyl rubber stopper. Cardboard box with 1 vial of 90 ml
  • Glass vials, type I closed with chlorobutyl rubber stoppers. Cardboard box with 1 vial of 15 ml.

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:
  • Forte Healthcare Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Pharmagal Bio spol. s r.o.
Responsible authority:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA10806/007/001
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0777/001
Concerned member states:
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 15/02/2026
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Combined File of all Documents

English (PDF)
Published on: 15/02/2026
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