Dexmedocord 0.5 mg/ml solution for injection for dogs and cats
Dexmedocord 0.5 mg/ml solution for injection for dogs and cats
Authorised
- Dexmedetomidine hydrochloride
Product identification
Medicine name:
Dexmedocord 0.5 mg/ml solution for injection for dogs and cats
Active substance:
- Dexmedetomidine hydrochloride
Target species:
-
Dog
-
Cat
Route of administration:
-
Intramuscular use
-
Intravenous use
Product details
Active substance and strength:
-
Dexmedetomidine hydrochloride0.50/milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QN05CM18
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
France
Package description:
- Type I clear glass vial with a fluoropolymer coated chlorobutyl rubber stopper and an aluminium overseal. Cardboard box containing one 10 ml vial
- Type I clear glass vial with a fluoropolymer coated chlorobutyl rubber stopper and an aluminium overseal. Cardboard box containing ten 10 ml vials
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Generic application (Article 18 of Regulation (EU) 2019/6)
Marketing authorisation holder:
- Accord Healthcare B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
- Fundacio Privada Dau
Responsible authority:
- French Agency For Food, Environmental And Occupational Health & Safety
Authorisation number:
- FR/V/2692570 9/2024
Date of authorisation status change:
Reference member state:
-
Ireland
Procedure number:
- IE/V/0888/001
Concerned member states:
-
Belgium
-
Bulgaria
-
Estonia
-
France
-
Germany
-
Italy
-
Latvia
-
Lithuania
-
Netherlands
-
Poland
-
Romania
-
Slovakia
-
Spain
-
United Kingdom (Northern Ireland)
Generic of:
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: 29/03/2026
French (PDF)
Published on: 11/12/2024
Package Leaflet and Labelling
This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 15/10/2025
Combined File of all Documents
English (PDF)
Download Published on: 30/11/2025
ie-puar-mr-iev0888001-dexmedocord-05-mgml-solution-for-injection-for-dog-en.pdf
English (PDF)
Download Published on: 30/11/2025