Veterinary Medicines

Sedator, 1.0 mg/ml, solution for injection for cats and dogs

Authorised
  • Medetomidine hydrochloride
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Product identification

Medicine name:
Sedator, 1.0 mg/ml, solution for injection for cats and dogs
Sedator 1 mg/ml Oplossing voor injectie
Sedator 1 mg/ml Solution injectable
Sedator 1 mg/ml Injektionslösung
Active substance:
  • Medetomidine hydrochloride
Target species:
  • Dog
  • Cat
Route of administration:
  • Intramuscular use
  • Intravenous use

Product details

Active substance and strength:
  • Medetomidine hydrochloride
    1.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Dog
    • Cat
  • Intravenous use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN05CM91
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Belgium
Package description:
  • (ID3) 20 millilitre(s): unspecified outer container with 1 Vial with 20 millilitre(s)
  • (ID2) 10 millilitre(s): unspecified outer container with 1 Vial with 10 millilitre(s)
  • (ID1) 5 millilitre(s): unspecified outer container with 1 Vial with 5 millilitre(s)

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:
  • Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Eurovet Animal Health B.V.
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V301007
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0119/001
Concerned member states:
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Finland
  • France
  • Greece
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Slovakia
  • Slovenia
  • Spain
  • Sweden

Documents

Summary of Product Characteristics

English (PDF)
Published on: 11/02/2022
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Dutch (PDF)
Published on: 22/03/2022
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French (PDF)
Published on: 22/03/2022
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 22/03/2022
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French (PDF)
Published on: 22/03/2022
Download
German (PDF)
Published on: 22/03/2022
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