Veterinary Medicines

KETEXX 100 MG/ML SOLUTION FOR INJECTION

Authorised
  • Ketamine hydrochloride
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Product identification

Medicine name:
KETEXX 100 MG/ML SOLUTION FOR INJECTION
Ketexx Vet 100 mg/ml Stungulyf, lausn handa hundum, köttum, nautgripum, kindum, geitum, hestum, naggrísum, hömstrum, kanínum, rottum og músum
Active substance:
  • Ketamine hydrochloride
Target species:
  • Cattle
  • Rat
  • Mouse
  • Hamster
  • Guinea pig
  • Rabbit (exclusively kept as pet)
  • Cat
  • Horse
  • Dog
  • Sheep
  • Goat
Route of administration:
  • Intramuscular use
  • Intravenous use
  • Intraperitoneal use

Product details

Active substance and strength:
  • Ketamine hydrochloride
    115.30
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        1
        day
      • Milk
        0
        day
    • Rabbit (exclusively kept as pet)
      • All relevant tissues
        no withdrawal period
    • Horse
      • Meat and offal
        1
        day
      • Milk
        0
        day
  • Intravenous use
    • Cattle
      • Meat and offal
        1
        day
      • Milk
        0
        day
    • Rabbit (exclusively kept as pet)
      • All relevant tissues
        no withdrawal period
    • Horse
      • Meat and offal
        1
        day
      • Milk
        0
        day
    • Sheep
      • Meat and offal
        1
        day
      • Milk
        0
        day
    • Goat
      • Meat and offal
        1
        day
      • Milk
        0
        day
  • Intraperitoneal use
    • Rabbit (exclusively kept as pet)
      • All relevant tissues
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN01AX03
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Iceland
Available in:
  • Iceland
Package description:
  • Polystyrene box holding 15 vials of 50 ml
  • Carton box holding 1 vial of 10 ml
  • Carton box holding 1 vial of 20 ml
  • Carton box holding 1 vial of 50 ml
  • Carton box holding 5 vials of 10 ml
  • Carton box holding 5 vials of 20 ml
  • Carton box holding 5 vials of 50 ml
  • Polystyrene box holding 35 vials of 10 ml
  • Polystyrene box holding 28 vials of 20 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:
  • Alfasan Nederland B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Alfasan Nederland B.V.
Responsible authority:
  • Icelandic Medicines Agency
Authorisation number:
  • IS/2/22/003/01
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0435/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • 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.
Icelandic (PDF)
Published on: 3/08/2022
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Icelandic (PDF)
Published on: 3/08/2022
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Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Icelandic (PDF)
Published on: 24/06/2025
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