Domosedan 10 mg/ml solution for injection for horses and cattle
Domosedan 10 mg/ml solution for injection for horses and cattle
Authorised
- DETOMIDINE HYDROCHLORIDE FOR VETERINARY USE
Product identification
Medicine name:
Domosedan 10 mg/ml Oplossing voor injectie
Domosedan 10 mg/ml Solution injectable
Domosedan 10 mg/ml Injektionslösung
Domosedan 10 mg/ml solution for injection for horses and cattle
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 USE10.00/milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Intramuscular use
-
Cattle
-
Meat and offal2day
-
Milk12hour
-
-
Horse
-
Meat and offal2day
-
-
-
Intravenous use
-
Cattle
-
Meat and offal2day
-
Milk12hour
-
-
Horse
-
Meat and offal2day
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QN05CM90
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Belgium
Package description:
- 1 x Type I clear glass vial containing 20 ml, closed with a chlorobutyl rubber stopper and an aluminium overseal, in a cardboard box.
- 1 x Type I clear glass vial containing 5 ml, closed with a chlorobutyl rubber stopper and an aluminium overseal, in a cardboard box.
- 6 x Type I clear glass vials containing 5 ml, closed with a chlorobutyl rubber stopper and an aluminium overseal, in a cardboard box.
- 10 x Type I clear glass vials containing 5 ml, closed with a chlorobutyl rubber stopper and an aluminium overseal, in a cardboard box.
- 5 x Type I clear glass vials containing 20 ml, closed with a chlorobutyl rubber stopper and an aluminium overseal, in a cardboard box.
- 10 x Type I clear glass vials containing 20 ml, closed with a chlorobutyl rubber stopper and an aluminium overseal, in a cardboard box.
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
- Orion Corporation
Marketing authorisation date:
Manufacturing sites for batch release:
- Orion Oyj / Orion Corporation / Orion Pharma
Responsible authority:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V138074
Date of authorisation status change:
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
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Package Leaflet
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Labelling
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Combined File of all Documents
English (PDF)
Download Published on: 12/12/2025
