Veterinary Medicines

Detogesic 10 mg/ml Solution for Injection for Horses

Authorised
  • DETOMIDINE HYDROCHLORIDE FOR VETERINARY USE
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Product identification

Medicine name:
Detogesic 10 mg/ml Solution for Injection for Horses
DETOGESIC 10 mg/ml raztopina za injiciranje za konje
Active substance:
  • DETOMIDINE HYDROCHLORIDE FOR VETERINARY USE
Target species:
  • Horse
Route of administration:
  • 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:
  • Intravenous use
    • Horse
      • Meat and offal
        2
        day
      • Milk
        12
        hour
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN05CM90
Legal status of supply:
This information is not available for this product.
Authorisation status:
  • Valid
Authorised in:
  • Slovenia
Package description:
  • Multidose, clear, cyclic olefin copolymer injection vial containing 15 ml solution, which may be closed with either a red bromobutyl rubber stopper or grey chlorobutyl rubber stopper, secured with an aluminium crimp.
  • Multidose, clear, Type I glass injection vial containing 10 ml solution which may be closed with either a red bromobutyl rubber stopper or grey chlorobutyl rubber stopper, secured with an aluminium crimp.

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:
  • Vetcare Oy
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Syva S.A.U.
Responsible authority:
  • Agency For Medicinal Products And Medical Devices Of The Republic Of Slovenia
Authorisation number:
  • MR/V/0441/001
Date of authorisation status change:
Reference member state:
  • Finland
Procedure number:
  • FI/V/0112/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)
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