Veterinary Medicine Information website

Spotinor 10 mg/ml Spot-on Solution for cattle and sheep

Authorised
  • Deltamethrin
Download as PDF

Product identification

Medicine name:
Spotinor 10 mg/ml Spot-on Solution for cattle and sheep
Active substance:
  • Deltamethrin
Target species:
  • Cattle
  • Sheep
Route of administration:
  • Spot-on use

Product details

Active substance and strength:
  • Deltamethrin
    10.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Spot-on solution
Withdrawal period by route of administration:
  • Spot-on use
    • Cattle
      • Meat and offal
        17
        day
      • Milk
        0
        hour
    • Sheep
      • Milk
        no withdrawal period
      • Meat and offal
        35
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP53AC11
Legal status of supply:
  • Veterinary medicinal product not subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Germany
Available in:
  • Germany
Package description:
  • (ID1) 250 millilitre(s): Box (cardboard) with 1 Bottle (high-density polyethylene) with 250 millilitre(s), closed with Screw cap (polypropylene)
  • (ID2) 500 millilitre(s): Box (cardboard) with 1 Bottle (high-density polyethylene) with 500 millilitre(s), closed with Screw cap (polypropylene)
  • (ID3) 1 litre(s): Box (cardboard) with 1 Container (high-density polyethylene) with 1 litre(s), closed with Screw cap (polypropylene)
  • (ID4) 2.5 litre(s): Box (cardboard) with 1 Container (high-density polyethylene) with 2.5 litre(s), closed with Screw cap (polypropylene)

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Norbrook Laboratories (Ireland) Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Norbrook Laboratories (Ireland) Limited
  • Norbrook Laboratories Limited
Responsible authority:
  • Federal Office Of Consumer Protection And Food Safety
Authorisation number:
  • 401978.00.00
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0320/001
Concerned member states:
  • Netherlands
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 18/09/2025
Download
German (PDF)
Published on: 18/09/2025
Download

2401978-paren-20200527.pdf

English (PDF)
Published on: 18/12/2024
Download