Veterinary Medicines

Rokopig, emulsion for injection for pigs

Authorised
  • Porcine rotavirus A, strain OSU 6, Inactivated
  • Escherichia coli, serotype O101:K99 (fimbrial adhesin F5), Inactivated
  • Escherichia coli, serotype O149:K88 (fimbrial adhesin F4), Inactivated
  • Escherichia coli, serotype O147:K88 (fimbrial adhesin F4), Inactivated
  • Escherichia coli, serotype K85:987P (fimbrial adhesin F6), Inactivated
  • Escherichia coli, serotype O101:K99 (fimbrial adhesins F5 and F41), Inactivated
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Product identification

Medicine name:
Rokopig, emulsion for injection for pigs
Active substance:
  • Porcine rotavirus A, strain OSU 6, Inactivated
  • Escherichia coli, serotype O101:K99 (fimbrial adhesin F5), Inactivated
  • Escherichia coli, serotype O149:K88 (fimbrial adhesin F4), Inactivated
  • Escherichia coli, serotype O147:K88 (fimbrial adhesin F4), Inactivated
  • Escherichia coli, serotype K85:987P (fimbrial adhesin F6), Inactivated
  • Escherichia coli, serotype O101:K99 (fimbrial adhesins F5 and F41), Inactivated
Target species:
  • Pig
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Porcine rotavirus A, strain OSU 6, Inactivated
    1.00
    relative potency
    /
    2.00
    millilitre(s)
  • Escherichia coli, serotype O101:K99 (fimbrial adhesin F5), Inactivated
    1.00
    relative potency
    /
    2.00
    millilitre(s)
  • Escherichia coli, serotype O149:K88 (fimbrial adhesin F4), Inactivated
    1.00
    relative potency
    /
    2.00
    millilitre(s)
  • Escherichia coli, serotype O147:K88 (fimbrial adhesin F4), Inactivated
    1.00
    relative potency
    /
    2.00
    millilitre(s)
  • Escherichia coli, serotype K85:987P (fimbrial adhesin F6), Inactivated
    1.00
    relative potency
    /
    2.00
    millilitre(s)
  • Escherichia coli, serotype O101:K99 (fimbrial adhesins F5 and F41), Inactivated
    1.00
    relative potency
    /
    2.00
    millilitre(s)
Pharmaceutical form:
  • Emulsion for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Pig
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI09AL02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Ireland
Package description:
  • Glass vial (hydrolytic glass class I) of 10 ml sealed with a rubber stopper (chlorobutyl material) and aluminium or flip-off cap, in a cardboard box. 1 × 10 ml (1 x 5 doses) in 10 ml glass vial hydrolytic class I
  • Glass vial (hydrolytic glass class II) of 50 ml sealed with a rubber stopper (chlorobutyl material) and aluminium or flip-off cap, in a cardboard box. 1 × 50 ml (1 x 25 doses) in 50 ml glass vial hydrolytic class II
  • High density polyethylene bottle of 60 ml sealed with a rubber stopper (chlorobutyl material) and aluminium or flip-off cap, in a cardboard. 1 × 50 ml (1 x 25 doses) in 60 ml HDPE plastic vial
  • Glass vial (hydrolytic glass class II) of 100 ml sealed with a rubber stopper (chlorobutyl material) and aluminium or flip-off cap, in a cardboard box. 1 × 100 ml (1 x 50 doses) in 100 ml glass vial hydrolytic class II
  • High density polyethylene bottle of 120 ml sealed with a rubber stopper (chlorobutyl material) and aluminium or flip-off cap, in a cardboard box. 1 × 100 ml (1 x 50 doses) in 120 ml HDPE plastic vial
  • High density polyethylene bottle of 250 ml sealed with a rubber stopper (chlorobutyl material) and aluminium or flip-off cap, in a cardboard box. 1 × 250 ml (1 x 125 doses) in 250 ml HDPE plastic bottle
  • Glass vial (hydrolytic glass class I) of 10 ml sealed with a rubber stopper (chlorobutyl material) and aluminium or flip-off cap, in a plastic box. 10 × 10 ml (10 x 5 doses) in 10 ml glass vial hydrolytic class I

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Similar biological application (Article 13(4) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Animal Health Distributors Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Bioveta a.s.
Responsible authority:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA22715/005/001
Date of authorisation status change:

Documents

Summary of Product Characteristics

English (PDF)
Published on: 25/09/2024
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