Veterinary Medicine Information website

Robonex 5 mg/ml Pour-on Solution for Dairy cattle and cattle for meat production

Authorised
  • Eprinomectin
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Product identification

Medicine name:
Robonex 5 mg/ml Pour-on Solution for Dairy cattle and cattle for meat production
Active substance:
  • Eprinomectin
Target species:
  • Cattle
Route of administration:
  • Pour-on use

Product details

Active substance and strength:
  • Eprinomectin
    5.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Pour-on solution
Withdrawal period by route of administration:
  • Pour-on use
    • Cattle
      • Meat and offal
        10
        day
      • Milk
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP54AA04
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • United Kingdom (Northern Ireland)
Package description:
  • Noreprinec 5 mg/ml pour-on sol. 1 l white HDPE backpack and white polypropylene screw cap
  • Noreprinec 5 mg/ml pour-on sol. 2.5 l white HDPE backpack and white polypropylene screw cap
  • Noreprinec 5 mg/ml pour-on sol. 5 l white HDPE backpack and white polypropylene screw cap
  • Noreprinec 5 mg/ml pour-on sol. 250 ml translucent HDPE container with integral squeeze measure pour system and white HDPE screw cap
  • Noreprinec 5 mg/ml pour-on sol. 1 l translucent HDPE container with integral squeeze measure pour system and white HDPE screw cap

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 18 of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • Norbrook Laboratories Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Norbrook Manufacturing Limited
  • Norbrook Laboratories Limited
Responsible authority:
  • The Veterinary Medicines Directorate
Authorisation number:
  • Vm 02000/4340
Date of authorisation status change:
Reference member state:
  • Belgium
Procedure number:
  • BE/V/0044/001
Concerned member states:
  • Luxembourg
  • Portugal
  • Spain
  • United Kingdom (Northern Ireland)
Generic of:

Documents

Labelling

English (PDF)
Published on: 13/03/2026
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English (PDF)
Published on: 14/03/2026
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Combined File of all Documents

English (PDF)
Published on: 13/03/2026
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Package Leaflet

English (PDF)
Published on: 13/03/2026
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English (PDF)
Published on: 14/03/2026
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Summary of Product Characteristics

English (PDF)
Published on: 13/03/2026
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English (PDF)
Published on: 14/03/2026
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