Veterinary Medicines

KETABEL 100 MG/ML SOLUTION FOR INJECTION

Authorised
  • Ketamine hydrochloride
Download as PDF

Product identification

Medicine name:
KETABEL 100 MG/ML SOLUTION FOR INJECTION
Ketabel 100 mg/ml ενέσιμο διάλυμα
Active substance:
  • Ketamine hydrochloride
Target species:
  • Cattle
  • Pig
  • Rat
  • Guinea pig
  • Rabbit
  • Cat
  • Sheep
  • Goat
  • Dog
  • Horse
  • Hamster
  • Mouse
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
    • Rat
    • Guinea pig
    • Rabbit
    • Cat
    • Sheep
      • Meat and offal
        1
        day
      • Milk
        0
        day
    • Goat
      • Meat and offal
        1
        day
      • Milk
        0
        day
    • Dog
  • Intravenous use
    • Cattle
      • Meat and offal
        1
        day
      • Milk
        0
        day
    • 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
    • Hamster
    • Rat
    • Mouse
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN01AX03
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Cyprus
Available in:
  • Cyprus
Package description:
  • Carton with 10 vials of 10 mL
  • Carton with 1 vial of 25 mL
  • Carton with 10 vials of 25 mL
  • Carton with 1 vial of 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:
  • Bela-Pharm GmbH & Co. KG
Marketing authorisation date:
Manufacturing sites for batch release:
  • Bela-Pharm GmbH & Co. KG
Responsible authority:
  • Ministry Of Agriculture Rural Development And Environment
Authorisation number:
  • CY00875V
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0338/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Norway
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Greek (PDF)
Published on: 6/06/2022
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."