Veterinary Medicines

Dorbene vet 1 mg/ml solution for injection for dogs and cats

Authorised
  • Medetomidine hydrochloride
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Product identification

Medicine name:
Dorbene vet 1 mg/ml solution for injection for dogs and cats
Dorbene vet 1 mg/ml инжекционен разтвор за кучета и котки
Active substance:
  • Medetomidine hydrochloride
Target species:
  • Cat
  • Dog
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
    • Cat
    • Dog
  • Intravenous use
    • Dog
  • Subcutaneous use
    • Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN05CM91
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Bulgaria
Available in:
  • Bulgaria
Package description:
  • Cardboard box with one colourless glass type II vial of 10 ml with a Teflon-coated type I chlorobutyl stopper and 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:
  • Laboratorios Syva S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Syva S.A.
Responsible authority:
  • Bulgarian Food Safety Authority
Authorisation number:
  • 0022-1852
Date of authorisation status change:
Reference member state:
  • Finland
Procedure number:
  • FI/V/0106/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • 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.
Bulgarian (PDF)
Published on: 14/10/2025
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Combined File of all Documents

English (PDF)
Published on: 25/07/2025
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Bulgarian (PDF)
Published on: 14/10/2025
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Bulgarian (PDF)
Published on: 14/10/2025
Download
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