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, oplossing voor injectie voor paarden en runderen
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:
  • Netherlands
Package description:
  • (ID3): 1 unspecified outer container with 1 Vial (-) with 20 millilitre(s) (20 millilitre(s))
  • (ID2): 1 unspecified outer container with 1 Vial (-) with 10 millilitre(s) (10 millilitre(s))
  • (ID1): 1 unspecified outer container with 1 Vial (-) with 5 millilitre(s) (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:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 10429
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

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Dutch (PDF)
Published on: 7/02/2022
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Summary of Product Characteristics

English (PDF)
Published on: 11/02/2022
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