Veterinary Medicine Information website

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

Authorised
  • Medetomidine hydrochloride
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Product identification

Medicine name:
SEDEDORM 1 MG/ML SOLUTION FOR INJECTION FOR DOGS AND CATS
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:
  • Poland
Package description:
  • Type I clear glass vials of 10 ml capacity. Vials are fitted with a bromobutyl stopper and sealed with an aluminium cap. Vials are packed in a cardboard box. Pack sizes: Box with 1 vial

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:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 1892
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

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 20/11/2025
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Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 20/11/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 20/11/2025
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