Veterinary Medicines

SEDIN 1 mg/ml solution for injection for cats and dogs

Authorised
  • Medetomidine hydrochloride
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Product identification

Medicine name:
SEDIN 1 mg/ml SOLUCION INYECTABLE PARA PERROS Y GATOS
SEDIN 1 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
Withdrawal period by route of administration:
  • Intramuscular use
    • Dog
    • Cat
  • Intravenous use
    • Dog
    • Cat
  • Subcutaneous use
    • Dog
    • Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN05CM91
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Spain
Available in:
  • Spain
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.
  • Chemical Iberica Productos Veterinarios S.L.
Responsible authority:
  • The Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 2076 ESP
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0151/001
Concerned member states:
  • Austria
  • Bulgaria
  • Germany
  • Latvia
  • Lithuania
  • Portugal
  • Slovenia

Documents

Summary of Product Characteristics

English (PDF)
Published on: 21/12/2023
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Spanish (PDF)
Published on: 17/03/2023
Download

Labelling

English (PDF)
Published on: 21/12/2023
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Spanish (PDF)
Published on: 17/03/2023
Download

Combined File of all Documents

English (PDF)
Published on: 21/11/2022
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 17/03/2023
Download

es-puar-sedin-1-mg-ml-solution-for-injection-for-cats-and-dogs-es.pdf

Spanish (PDF)
Published on: 17/03/2023
Download
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