Veterinary Medicine Information website

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

Authorised
  • Deltamethrin
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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
      • Meat and offal
        35
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP53AC11
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Denmark
Available in:
  • Denmark
Package description:
  • 2.5 litre white high density polyethylene back pack for use with a suitable dosing device and a white screwpolypropylene cap in a cardboard box.
  • 2 x 500 ml clear high-density polyethylene bottle with internal graduated calibration chamber and awhite screw polypropylene cap in a cardboard box.
  • 1 litre white high density polyethylene back pack for use with a suitable dosing device and a white screwpolypropylene cap in a cardboard box.
  • 1 x 500 ml clear high-density polyethylene bottle with internal graduated calibration chamber and awhite screw polypropylene cap in a cardboard box.
  • 250 ml clear high-density polyethylene bottle with internal graduated calibration chamber and awhite screw polypropylene cap in a cardboard box.

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 Limited
  • Norbrook Manufacturing Limited
Responsible authority:
  • Danish Medicines Agency
Authorisation number:
  • 52375
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0544/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Cyprus
  • Denmark
  • Estonia
  • Finland
  • France
  • Greece
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Malta
  • Poland
  • Portugal
  • Romania
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 2/03/2025
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Danish (PDF)
Published on: 29/06/2023
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Combined File of all Documents

English (PDF)
Published on: 2/03/2025
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