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, 1.0 mg/ml, solution for injection for cats and dogs
Active substance:
  • Medetomidine hydrochloride
Target species:
  • Dog
  • Cat
Route of administration:
  • Intramuscular use
  • Intravenous use
  • Subcutaneous 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:
  • Ireland
Package description:
  • Clear colourless, sterile aqueous solution and presented in a Type I clear glass vial of 5 ml capacity, each packed in a cardboard box. Vials are fitted with a teflon coated halogenated rubber stopper and sealed with an aluminium cap.
  • Clear colourless, sterile aqueous solution and presented in a Type I clear glass vial of 10 ml capacity, each packed in a cardboard box. Vials are fitted with a teflon coated halogenated rubber stopper and sealed with an aluminium cap.
  • Clear colourless, sterile aqueous solution and presented in a Type I clear glass vial of 20 ml capacity, each packed in a cardboard box. Vials are fitted with a teflon coated halogenated rubber stopper and sealed with an aluminium cap.

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:
  • Eurovet Animal Health B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Eurovet Animal Health B.V.
Responsible authority:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA10989/057/001
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0476/001
Concerned member states:
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 27/10/2024
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