Veterinary Medicines

Doramax 10 mg/ml Solution for Injection for Cattle, Sheep and Pigs

Authorised
  • Doramectin
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Product identification

Medicine name:
Doramax 10 mg/ml Solution for Injection for Cattle, Sheep and Pigs
DORIMEC 10 MG/ML SOLUTION INJECTABLE POUR BOVINS OVINS ET PORCINS
Active substance:
  • Doramectin
Target species:
  • Sheep
  • Pig
  • Cattle
Route of administration:
  • Intramuscular use
  • Subcutaneous use

Product details

Active substance and strength:
  • Doramectin
    10.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Sheep
      • Meat and offal
        70
        day
    • Pig
      • Meat and offal
        77
        day
  • Subcutaneous use
    • Cattle
      • Meat and offal
        70
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP54AA03
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • France
Package description:
  • Type II amber glass multi-dose vials, with chlorobutyl rubber stoppers secured with an aluminium cap. Package sizes: Cardboard box containing 1 vial of 500 ml.
  • Type II amber glass multi-dose vials, with chlorobutyl rubber stoppers secured with an aluminium cap. Package sizes: Cardboard box containing 1 vial of 250 ml.
  • Type II amber glass multi-dose vials, with chlorobutyl rubber stoppers secured with an aluminium cap. Package sizes: Cardboard box containing 1 vial of 50 ml.

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:
  • Chanelle Pharmaceuticals Manufacturing Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Chanelle Pharmaceuticals Manufacturing Limited
Responsible authority:
  • French Agency For Food, Environmental And Occupational Health & Safety
Authorisation number:
  • FR/V/3673141 9/2022
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0770/001
Concerned member states:
  • Austria
  • Belgium
  • Croatia
  • Denmark
  • France
  • Germany
  • Hungary
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Spain

Documents

Summary of Product Characteristics

English (PDF)
Published on: 24/11/2024
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French (PDF)
Published on: 7/11/2025
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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: 7/11/2025
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Combined File of all Documents

English (PDF)
Published on: 24/11/2024
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ie-puar-mr-iev0770001-doramax-10-mgml-solution-for-injection-for-cattle--en.pdf

English (PDF)
Published on: 24/11/2024
Download