Veterinary Medicines

Butorgesic 10 mg/ml solution for injection

Authorised
  • Butorphanol tartrate
  • Butorphanol tartrate
  • Butorphanol tartrate
  • Butorphanol tartrate
Download as PDF

Product identification

Medicine name:
Butorgesic 10 mg/ml solution for injection
Butorgesic vet 10 mg/ml injeksjonsvæske, oppløsning til hest, hund og katt
Active substance:
  • Butorphanol tartrate
  • Butorphanol tartrate
  • Butorphanol tartrate
  • Butorphanol tartrate
Target species:
  • Cat
  • Dog
  • Horse
Route of administration:
  • Intravenous use
  • Intramuscular use
  • Subcutaneous use

Product details

Active substance and strength:
  • Butorphanol tartrate
    14.58
    milligram(s)
    /
    1.00
    millilitre(s)
  • Butorphanol tartrate
    14.58
    milligram(s)
    /
    1.00
    millilitre(s)
  • Butorphanol tartrate
    14.58
    milligram(s)
    /
    1.00
    millilitre(s)
  • Butorphanol tartrate
    14.58
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intravenous use
    • Cat
    • Dog
    • Horse
      • Milk
        0
        day
      • Milk
        0
        day
      • Milk
        0
        day
      • Milk
        0
        day
      • Meat and offal
        0
        day
      • Meat and offal
        0
        day
      • Meat and offal
        0
        day
      • Meat and offal
        0
        day
  • Intramuscular use
    • Dog
    • Horse
    • Cat
  • Subcutaneous use
    • Dog
    • Horse
    • Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN02AF01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Norway
Available in:
  • Norway
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:
  • CP-Pharma Handelsgesellschaft mbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • CP-Pharma Handelsgesellschaft mbH
Responsible authority:
  • Norwegian Medical Products Agency
Authorisation number:
  • 19-13174
Date of authorisation status change:
Reference member state:
  • Denmark
Procedure number:
  • DK/V/0124/001
Concerned member states:
  • Austria
  • Finland
  • France
  • Hungary
  • Italy
  • Norway
  • Sweden

Documents

Summary of Product Characteristics

English (PDF)
Published on: 25/01/2022
Download
Norwegian (PDF)
Published on: 27/01/2022
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."