Detonervin 10 mg/ml, solution for injection for horses and cattle
Detonervin 10 mg/ml, solution for injection for horses and cattle
Authorised
- DETOMIDINE HYDROCHLORIDE FOR VETERINARY USE
Product identification
Medicine name:
Detonervin 10 mg/ml, solution for injection for horses and cattle
Detonervin vet 10 mg/ml injektioneste, liuos
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 USE10.00milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Intramuscular use
- Cattle
-
Milk12hour
-
Meat and offal2day
-
- Horse
-
Meat and offal2day
-
-
Intravenous use
- Cattle
-
Milk12hour
-
Meat and offal2day
-
- 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:
-
Finland
Package description:
- Clear colourless glass (type I) vials closed with a coated bromobutyl rubber stopper (type I) and an aluminium cap with a polypropylene lid. 5 x 1 glass vials with 20 ml.
- Clear colourless glass (type I) vials closed with a coated bromobutyl rubber stopper (type I) and an aluminium cap with a polypropylene lid. 5 x 1 glass vial with 5 ml.
- Clear colourless glass (type I) vials closed with a coated bromobutyl rubber stopper (type I) and an aluminium cap with a polypropylene lid. 1 x 1 glass vial with 5 ml.
- Clear colourless glass (type I) vials closed with a coated bromobutyl rubber stopper (type I) and an aluminium cap with a polypropylene lid. 1 x 1 glass vial with 20 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:
- Le Vet. B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
- Produlab Pharma B.V.
Responsible authority:
- Finnish Medicines Agency
Authorisation number:
- 28432
Date of authorisation status change:
Reference member state:
-
Netherlands
Procedure number:
- NL/V/0147/001
Concerned member states:
-
Austria
-
Belgium
-
Czechia
-
Denmark
-
Finland
-
France
-
Greece
-
Hungary
-
Iceland
-
Ireland
-
Italy
-
Luxembourg
-
Poland
-
Portugal
-
Slovakia
-
Spain
-
Sweden
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
English (PDF)
Download Published on: 16/06/2022
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