Veterinary Medicines

BUTORVET 10 MG/ML SOLUTION FOR INJECTION

Authorised
  • Butorphanol tartrate
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Product identification

Medicine name:
BUTORVET 10 MG/ML SOLUTION FOR INJECTION
BUTORVET 10 MG/ML SOLUTION INJECTABLE
Active substance:
  • Butorphanol tartrate
Target species:
  • Dog
  • Cat
  • Horse
Route of administration:
  • Intramuscular use
  • Subcutaneous use
  • Intravenous use

Product details

Active substance and strength:
  • Butorphanol tartrate
    14.58
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intravenous use
    • Horse
      • Meat and offal
        0
        day
      • Milk
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN02AF01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • France
Package description:
  • Cardboard box containing 1 vial of 10 ml. Type I amber glass multi-dose vial, with chlorobutyl rubber stoppers secured with an aluminium cap.
  • Cardboard box containing 1 vial of 20 ml. Type I amber glass multi-dose vial, with chlorobutyl rubber stoppers secured with an aluminium cap.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 18 of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • Chanelle Pharmaceuticals Manufacturing Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Chanelle Pharmaceuticals Manufacturing Limited
Responsible authority:
  • French Agency For Food, Environmental And Occupational Health & Safety
Authorisation number:
  • FR/V/9965983 7/2025
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0492/001
Concerned member states:
  • Belgium
  • Denmark
  • Finland
  • Germany
  • Greece
  • Ireland
  • Italy
  • Netherlands
  • Norway
  • Portugal
  • Spain
  • Sweden
Generic of:

Documents

Package Leaflet and Labelling

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 7/04/2025
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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: 7/04/2025
Download

Combined File of all Documents

English (PDF)
Published on: 7/04/2025
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