Veterinary Medicines

Domidine 10 mg/ml solution for injection for horses and cattle

Authorised
  • DETOMIDINE HYDROCHLORIDE FOR VETERINARY USE
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Product identification

Medicine name:
Domidine 10 mg/ml solution for injection for horses and cattle
Domidine 10 mg/ml Injektionslösung für Pferde und Rinder
Active substance:
  • DETOMIDINE HYDROCHLORIDE FOR VETERINARY USE
Target species:
  • Cattle
  • Horse
Route of administration:
  • Intramuscular use
  • Intravenous use

Product details

Active substance and strength:
  • DETOMIDINE HYDROCHLORIDE FOR VETERINARY USE
    10.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Milk
        12
        hour
      • Meat and offal
        2
        day
    • Horse
      • Milk
        12
        hour
      • Meat and offal
        2
        day
  • Intravenous use
    • Cattle
      • Milk
        12
        hour
      • Meat and offal
        2
        day
    • Horse
      • Milk
        12
        hour
      • Meat and offal
        2
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN05CM90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Germany
Package description:
  • (ID3) 20 millilitre(s): unspecified outer container with 1 Vial with 20 millilitre(s)
  • (ID2) 10 millilitre(s): unspecified outer container with 1 Vial with 10 millilitre(s)
  • (ID1) 5 millilitre(s): unspecified outer container with 1 Vial with 5 millilitre(s)

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:
  • Eurovet Animal Health B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Eurovet Animal Health B.V.
Responsible authority:
  • Federal Office Of Consumer Protection And Food Safety
Authorisation number:
  • 400880.00.00
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0115/001
Concerned member states:
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • France
  • Hungary
  • Ireland
  • Italy
  • Lithuania
  • Luxembourg
  • Netherlands
  • Poland
  • Portugal
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 24/07/2025
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Summary of Product Characteristics

English (PDF)
Published on: 12/01/2026
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2400880-paren-20070123.pdf

English (PDF)
Published on: 12/01/2026
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