Detogesic 10 mg/ml Solution for Injection for Horses
Detogesic 10 mg/ml Solution for Injection for Horses
Authorised
- DETOMIDINE HYDROCHLORIDE FOR VETERINARY USE
Product identification
Medicine name:
Detogesic 10 mg/ml Solution for Injection for Horses
Detogesic 10 mg/ml Solution injectable
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 USE10.00milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Intravenous use
- Horse
-
Meat and offal2day
-
Milk12hour
-
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:
- 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:
- Ministere De La Sante Division De La Pharmacie Et Des Medicaments
Authorisation number:
- V/445/08/06/0944
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)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 22/06/2022
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