Product class:
|
Authorized package
|
Medicinal product class:
|
Veterinary medicine
|
Package code:
|
1771680
|
Name of medicinal product:
|
Ketabel
|
Active substances:
|
|
ATC code:
|
QN01AX03
|
Dosage form:
|
solution for injection
|
Route of administration:
|
intravenous use
|
Strengh:
|
100mg 1ml
|
Amount in package:
|
25ml 1TK
|
Legal status for supply*:
|
Subject to medicinal prescription
|
Class of active substance:
|
Psychotropic
|
Additional information:
|
|
Indication:
|
The product may be used in combination with a sedative for:
- Immobilisation
- Sedation
-General anaesthesia
|
Safety features:
|
No
|
Summary of product characteristics (SPC):
|
(last updated August 26, 2021)
|
Package information leaflet (PIL):
|
EST (last updated August 26, 2021)
|
Labelling:
|
(last updated June 30, 2020)
|
Withdrawal time:
|
Veised, lambad, kitsed ja hobused
Lihale ja söödavatele kudedele: 1 päev.
Piimale: 0 tundi.
Sead
Lihale ja söödavatele kudedele: 1 päev.
|
Species:
|
hamster, rott, merisiga, hiir, koer, hobune, küülik, lammas, siga, kass, veis, kits
|
Last imported to Estonia:
|
September 14, 2023
|
Marketing authorization holder:
|
Bela-Pharm GmbH & Co. KG
|
Marketing authorization number:
|
2245
|
Marketing authorization issued on:
|
June 30, 2020
|
Marketing authorization expires on:
|
June 30, 2025
|
Marketing authorization procedure type:
|
Decentralised
|
Entry/Changing date:
November 22, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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