Veterinary Medicines

Dolorex 10 mg/ml Solution for Injection for horse, dog and cat

Authorised
  • Butorphanol tartrate
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Product identification

Medicine name:
Dolorex 10 mg/ml Solution for Injection for horse, dog and cat
Butordol 10 mg/ml injektioneste, liuos, hevoselle, koiralle ja kissalle
Active substance:
  • Butorphanol tartrate
Target species:
  • Dog
  • Horse
  • Cat
Route of administration:
  • Intramuscular use
  • Intravenous use
  • Subcutaneous use

Product details

Active substance and strength:
  • Butorphanol tartrate
    14.60
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Dog
  • Intravenous use
    • Dog
    • Horse
      • Meat and offal
        0
        day
      • Milk
        0
        hour
  • Subcutaneous use
    • Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN02AF01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Finland
Package description:
  • Cardboard box with 1 glass vial (type I) of 50 ml with a halogenated butyl rubber stopper (type I) and analuminium cap.
  • Cardboard box with 1 glass vial (type I) of 10 ml with a halogenated butyl rubber stopper (type I) and analuminium cap.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Well-established use application (Article 13a of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Intervet International B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Intervet International GmbH
Responsible authority:
  • Finnish Medicines Agency
Authorisation number:
  • 22887
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0194/001
Concerned member states:
  • Belgium
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Luxembourg
  • Netherlands
  • Norway
  • Portugal
  • Slovakia
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 29/12/2024
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Combined File of all Documents

English (PDF)
Published on: 29/12/2024
Download

ie-puar-mr-iev0194001-dolorex-10-mgml-solution-for-injection-for-horse-d-en.pdf

English (PDF)
Published on: 26/08/2024
Download
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