Veterinary Medicines

Anesketin 100 mg/ml Solution for Injection

Authorised
  • Ketamine hydrochloride
Download as PDF

Product identification

Medicine name:
Anesketin 100 mg/ml Solution for Injection
Nimatek 100 mg/ml Oplossing voor injectie
Nimatek 100 mg/ml Solution injectable
Nimatek 100 mg/ml Injektionslösung
Active substance:
  • Ketamine hydrochloride
Target species:
  • Horse
  • Dog
  • Cat
Route of administration:
  • Intramuscular use
  • Intravenous use
  • Subcutaneous use

Product details

Active substance and strength:
  • Ketamine hydrochloride
    115.40
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Horse
      • Milk
        1
        day
      • Meat and offal
        1
        day
  • Intravenous use
    • Horse
      • Milk
        1
        day
      • Meat and offal
        1
        day
  • Subcutaneous use
    • Horse
      • Milk
        1
        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:
  • Belgium
Package description:
  • Clear colourless type I glass vials with bromobutyl rubber stoppers and aluminium caps filled with 50 ml, 1 vial in a cardboard box
  • Clear colourless type I glass vials with bromobutyl rubber stoppers and aluminium caps filled with 5 ml, 1 vial in a cardboard box
  • Clear colourless type I glass vials with bromobutyl rubber stoppers and aluminium caps filled with 30 ml, 1 vial in a cardboard box
  • Clear colourless type I glass vials with bromobutyl rubber stoppers and aluminium caps filled with 25 ml, 1 vial in a cardboard box
  • Clear colourless type I glass vials with bromobutyl rubber stoppers and aluminium caps filled with 20 ml, 1 vial in a cardboard box
  • Clear colourless type I glass vials with bromobutyl rubber stoppers and aluminium caps filled with 10 ml, 1 vial in a cardboard box

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:
  • Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Eurovet Animal Health B.V.
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V439546
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0278/001
Concerned member states:
  • Belgium
  • Denmark
  • France
  • Germany
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 10/11/2025
Download

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 18/08/2025
Download
French (PDF)
Published on: 18/08/2025
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 18/08/2025
Download
French (PDF)
Published on: 18/08/2025
Download
German (PDF)
Published on: 18/08/2025
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 14/08/2025
Download
French (PDF)
Published on: 14/08/2025
Download
German (PDF)
Published on: 14/08/2025
Download