Veterinary Medicines

NIMATEK 100 mg/ml, Solution for injection for dogs, cats and horses

Authorised
  • Ketamine hydrochloride
Download as PDF

Product identification

Medicine name:
NIMATEK 100 mg/ml, Solution for injection for dogs, cats and horses
Nimatek Vet. 100 mg/ml Injektionsvätska, lösning
Active substance:
  • Ketamine hydrochloride
Target species:
  • Dog
  • Cat
  • Horse
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:
  • Intravenous use
    • Horse
      • Meat and offal
        1
        day
      • Milk
        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:
  • Sweden
Package description:
  • Clear colourless type I glass vial with bromobutyl rubber stopper and aluminium cap filled with 5 ml.1 vial in a cardboard box.
  • Clear colourless type I glass vial with bromobutyl rubber stopper and aluminium cap filled with 10 ml.1 vial in a cardboard box.
  • Clear colourless type I glass vial with bromobutyl rubber stopper and aluminium cap filled with 20 ml.1 vial in a cardboard box.
  • Clear colourless type I glass vial with bromobutyl rubber stopper and aluminium cap filled with 25 ml.1 vial in a cardboard box.
  • Clear colourless type I glass vial with bromobutyl rubber stopper and aluminium cap filled with 30 ml.1 vial in a cardboard box.
  • Clear colourless type I glass vial with bromobutyl rubber stopper and aluminium cap filled with 50 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:
  • Eurovet Animal Health B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Eurovet Animal Health B.V.
Responsible authority:
  • Swedish Medical Products Agency
Authorisation number:
  • 49564
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0475/001
Concerned member states:
  • Austria
  • Finland
  • Italy
  • Poland
  • Portugal
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 6/10/2024
Download
Swedish (PDF)
Published on: 9/06/2023
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Swedish (PDF)
Published on: 9/06/2023
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Swedish (PDF)
Published on: 21/06/2023
Updated on: 26/06/2023
Download