File downloaded on 2026-04-04
Source URL: https://medicines.health.europa.eu/veterinary/en/600000036957
Authorised

Product identification

Medicine name:
Detonervin 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 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
      • Meat and offal
        2
        day
  • Intravenous use
    • Cattle
      • Milk
        12
        hour
      • Meat and offal
        2
        day
    • Horse
      • 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:
  • Luxembourg
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:
  • Ministry Of Health And Social Security
Authorisation number:
  • V/333/11/01/1039
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)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 16/06/2022
Download
French (PDF)
Published on: 22/06/2022
Updated on: 23/06/2022
Download

Combined File of all Documents

English (PDF)
Published on: 13/06/2025
Updated on: 12/06/2025
Download