Veterinary Medicines

Butorgesic 10 mg/ml solution for injection

Authorised
  • Butorphanol tartrate
  • Butorphanol tartrate
  • Butorphanol tartrate
  • Butorphanol tartrate
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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
    • 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
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
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Norwegian (PDF)
Published on: 27/01/2022
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