Veterinary Medicines

DECTOSPOT 10 MG/ML POUR-ON SOLUTION FOR CATTLE AND SHEEP

Authorised
  • Deltamethrin
Download as PDF

Product identification

Medicine name:
DECTOSPOT 10 MG/ML POUR-ON SOLUTION FOR CATTLE AND SHEEP
DECTOSPOT 10 MG/ML SOLUTION POUR-ON POUR BOVINS ET OVINS
Active substance:
  • Deltamethrin
Target species:
  • Cattle
  • Sheep
Route of administration:
  • Cutaneous use

Product details

Active substance and strength:
  • Deltamethrin
    10.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Pour-on solution
Withdrawal period by route of administration:
  • Cutaneous use
    • Cattle
      • Meat and offal
        18
        day
      • Milk
        0
        day
    • Sheep
      • Meat and offal
        35
        day
      • Milk
        24
        hour
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP53AC11
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • France
Package description:
  • 500 ml high density polyethylene flexipacks with twin neck dispenser, internal graduated calibration chamber and polypropylene heat-sealed screw cap.
  • 1 litre high-density polyethylene flat bottom containers with polypropylene closures and tamper evident with induction heat-sealed wadding. A spouted cap is provided with the 1 litre presentations.
  • 2.5 litre high-density polyethylene flat bottom containers with polypropylene closures and tamper evident with induction heat-sealed wadding. A spouted cap is provided with the 2.5 litre presentations.
  • 250 ml high density polyethylene flexipacks with twin neck dispenser, internal graduated calibration chamber and polypropylene heat-sealed screw cap.

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:
  • Bimeda Animal Health Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Bimeda Animal Health Limited
Responsible authority:
  • French Agency For Food, Environmental And Occupational Health & Safety
Authorisation number:
  • FR/V/6739546 0/2016
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0293/001
Concerned member states:
  • Austria
  • Belgium
  • Denmark
  • Estonia
  • Finland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Poland
  • Portugal
  • Romania
  • Spain
  • Sweden

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 8/01/2024
Download

Package Leaflet and Labelling

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 29/11/2023
Download

Combined File of all Documents

English (PDF)
Published on: 19/02/2024
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."