Veterinary Medicines

Reverse 5 mg/ml solution for injection for dogs and cats

Authorised
  • Atipamezole hydrochloride
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Product identification

Medicine name:
Reverse 5 mg/ml solution for injection for dogs and cats
Reverse 5 mg/ml solução injetável para cães e gatos
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:
  • Portugal
Package description:
  • box containing 1 vial of 10 ml

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:
  • Fatro S.p.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Labiana Life Sciences S.A.
Responsible authority:
  • Directorate General For Food And Veterinary
Authorisation number:
  • 987/01/16DFVPT
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0233/001
Concerned member states:
  • Italy
  • Portugal

Documents

Summary of Product Characteristics

English (PDF)
Published on: 11/04/2023
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Package Leaflet

English (PDF)
Published on: 11/04/2023
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Labelling

English (PDF)
Published on: 11/04/2023
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Combined File of all Documents

English (PDF)
Published on: 24/07/2025
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Portuguese (PDF)
Published on: 11/01/2024
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eu-PUAR-reverse-en.pdf

English (PDF)
Published on: 11/04/2023
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