Veterinary Medicine Information website

DEXMOPET SOLUTION FOR INJECTION FOR DOGS AND CATS

Authorised
  • Dexmedetomidine hydrochloride
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Product identification

Medicine name:
DEXMOPET SOLUTION FOR INJECTION FOR DOGS AND CATS
Active substance:
  • Dexmedetomidine hydrochloride
Target species:
  • Dog
  • Cat
Route of administration:
  • Intramuscular use
  • Intravenous use

Product details

Active substance and strength:
  • Dexmedetomidine hydrochloride
    0.50
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN05CM18
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Belgium
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:
  • Chemical Iberica Productos Veterinarios S.L.
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V508462
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0290/001
Concerned member states:
  • Belgium
  • Bulgaria
  • Cyprus
  • Czechia
  • Denmark
  • Germany
  • Ireland
  • Norway
  • Poland
  • Portugal
  • Slovakia
  • Spain
  • Sweden

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 28/02/2026
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German (PDF)
Published on: 28/02/2026
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Dutch (PDF)
Published on: 28/02/2026
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 28/02/2026
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German (PDF)
Published on: 28/02/2026
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Dutch (PDF)
Published on: 28/02/2026
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Labelling

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 28/02/2026
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German (PDF)
Published on: 28/02/2026
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Dutch (PDF)
Published on: 28/02/2026
Download

eu-puar-frv0290001-mr-rpe334-en.pdf

English (PDF)
Published on: 13/03/2026
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