Veterinary Medicines Information website

ANAESTAMINE 100 MG/ML SOLUTION FOR INJECTION

Authorised
  • Ketamine hydrochloride
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Product identification

Medicine name:
ANAESTAMINE 100 MG/ML SOLUTION FOR INJECTION
Active substance:
  • Ketamine hydrochloride
Target species:
  • Cattle
  • Pig
  • Rat
  • Mouse
  • Hamster
  • Guinea pig
  • Rabbit
  • Cat
  • Horse
  • Horse (mare)
  • Sheep
  • Goat
  • Dog
Route of administration:
  • Intramuscular use
  • Intravenous use
  • Intraperitoneal use

Product details

Active substance and strength:
  • Ketamine hydrochloride
    115.34
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Milk
        0
        day
      • Meat and offal
        1
        day
    • Pig
      • Meat and offal
        1
        day
    • Horse
      • Meat and offal
        1
        day
    • Horse (mare)
      • Milk
        0
        day
    • Sheep
      • Milk
        0
        day
      • Meat and offal
        1
        day
    • Goat
      • Milk
        0
        day
      • Meat and offal
        1
        day
  • Intravenous use
    • Cattle
      • Milk
        0
        day
      • Meat and offal
        1
        day
    • Pig
      • Meat and offal
        1
        day
    • Horse
      • Meat and offal
        1
        day
    • Horse (mare)
      • Milk
        0
        day
    • Sheep
      • Milk
        0
        day
      • Meat and offal
        1
        day
    • Goat
      • Milk
        0
        day
      • Meat and offal
        1
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN01AX03
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Denmark
Package description:
  • Vial containing 50 ml in a carton box
  • Vial containing 10 ml in a carton box
  • Vial containing 25 ml in a carton box

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:
  • Le Vet. Beheer B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Produlab Pharma B.V.
Responsible authority:
  • Danish Medicines Agency
Authorisation number:
  • 54401
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0262/001
Concerned member states:
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Danish (, INJEKTIONSVÆSKE, OPLØSNING 100 MG-ML)
Published on: 29/06/2023
Download

eu-puar-frv0262001-mr-rpe_152-en.pdf

English (PDF)
Published on: 13/03/2026
Download