Veterinary Medicines

Ketamidor 100 mg/ml - Injektionslösung für Tiere

Authorised
  • Ketamine hydrochloride
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Product identification

Medicine name:
Ketamidor 100 mg/ml - Injektionslösung für Tiere
Ketamidor 100 mg/ml raztopina za injiciranje
Active substance:
  • Ketamine hydrochloride
Target species:
  • Dog
  • Cat
  • Pig
  • Cattle
  • Horse
Route of administration:
  • Intramuscular use
  • Intravenous use
  • Subcutaneous use

Product details

Active substance and strength:
  • Ketamine hydrochloride
    115.33
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Dog
    • Cat
    • Pig
      • Meat and offal
        0
        day
  • Intravenous use
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        0
        day
    • Dog
    • Horse
      • Meat and offal
        0
        day
      • Milk
        0
        day
    • Cat
  • Subcutaneous use
    • Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN01AX03
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Slovenia
Package description:
  • Clear glass vial, type I (Ph. Eur.) with bromobutyl-rubber stopper type I (Ph.Eur.) and aluminium cap, packed in a cardboard box. Package size: 1 x 10 ml
  • Clear glass vial, type I (Ph. Eur.) with bromobutyl-rubber stopper type I (Ph.Eur.) and aluminium cap, packed in a cardboard box. Package size: 1 x 50 ml
  • Clear glass vial, type I (Ph. Eur.) with bromobutyl-rubber stopper type I (Ph.Eur.) and aluminium cap, packed in a cardboard box. Package size: 5 x 10 ml

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:
  • Vetviva Richter GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Vetviva Richter GmbH
Responsible authority:
  • Agency For Medicinal Products And Medical Devices Of The Republic Of Slovenia
Authorisation number:
  • MR/V/0544/001
Date of authorisation status change:
Reference member state:
  • Austria
Procedure number:
  • AT/V/0009/001
Concerned member states:
  • Belgium
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Netherlands
  • Poland
  • Portugal
  • Slovenia
  • 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.
Slovenian (PDF)
Published on: 15/12/2023
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 15/12/2023
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 15/12/2023
Download
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