Veterinary Medicines

ATIPAZOLE 5 MG/ML SOLUTION FOR INJECTION FOR DOGS AND CATS

Authorised
  • Atipamezole hydrochloride
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Product identification

Medicine name:
ATIPAZOLE 5 MG/ML SOLUTION FOR INJECTION FOR DOGS AND CATS
Atipazole 5 mg/ml Oplossing voor injectie
Atipazole 5 mg/ml Solution injectable
Atipazole 5 mg/ml Injektionslösung
Active substance:
  • Atipamezole hydrochloride
Target species:
  • Dog
  • Cat
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Atipamezole hydrochloride
    5.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QV03AB90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Belgium
Available 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:
  • Labiana Life Sciences S.A.
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V442242
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0247/001
Concerned member states:
  • Belgium
  • Bulgaria
  • Cyprus
  • Germany
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Poland
  • Portugal
  • Slovenia
  • Spain
  • 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.
Dutch (PDF)
Published on: 17/08/2025
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French (PDF)
Published on: 17/08/2025
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German (PDF)
Published on: 17/08/2025
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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: 17/08/2025
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French (PDF)
Published on: 17/08/2025
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German (PDF)
Published on: 17/08/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 17/08/2025
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French (PDF)
Published on: 17/08/2025
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German (PDF)
Published on: 17/08/2025
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eu-puar-frv0247001-mr-rpe_110-en.pdf

English (PDF)
Published on: 7/01/2026
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