Veterinary Medicines

Torphasol 10 mg/ml solution for injection for horses

Authorised
  • Butorphanol tartrate
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Product identification

Medicine name:
Torphasol 10 mg/ml solution for injection for horses
Morphasol 10 mg/ml Roztwór do wstrzykiwań
Active substance:
  • Butorphanol tartrate
Target species:
  • Horse
Route of administration:
  • Intravenous use

Product details

Active substance and strength:
  • Butorphanol tartrate
    14.70
    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:
  • Poland
Package description:
  • Cardboard box with 1 clear glass vial (type I) of 20 ml with a grey butyl rubber stopper and an aluminium cap.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application (Article 13(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • aniMedica GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • aniMedica GmbH
  • Industrial Veterinaria S.A.
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 2016
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0246/001
Concerned member states:
  • Austria
  • Belgium
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Hungary
  • Iceland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 11/02/2022
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Polish (PDF)
Published on: 23/05/2022
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 23/05/2022
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Combined File of all Documents

English (PDF)
Published on: 24/08/2025
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