Veterinary Medicines

SEDEDORM 1 MG/ML SOLUTION FOR INJECTION FOR DOGS AND CATS

Authorised
  • Medetomidine hydrochloride
Download as PDF

Product identification

Medicine name:
SEDEDORM 1 MG/ML SOLUTION FOR INJECTION FOR DOGS AND CATS
SEDEDORM SOLUTION INJECTABLE POUR CHIENS ET CHATS
Active substance:
  • Medetomidine hydrochloride
Target species:
  • Dog
  • Cat
Route of administration:
  • Intramuscular use
  • Subcutaneous use
  • Intravenous use

Product details

Active substance and strength:
  • Medetomidine hydrochloride
    1.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN05CM91
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • France
Available in:
  • France
Package description:

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:
  • Vetpharma Animal Health S.L.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Industrial Veterinaria S.A.
Responsible authority:
  • French Agency For Food, Environmental And Occupational Health & Safety
Authorisation number:
  • FR/V/8390307 4/2009
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0192/001
Concerned member states:
  • Belgium
  • Germany
  • Hungary
  • Netherlands
  • Poland
  • Portugal
  • Spain
  • United Kingdom (Northern Ireland)

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: 9/04/2025
Download

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: 24/11/2025
Download