Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: Veterinary medicine
Package code: 1771680
Name of medicinal product: Ketabel
Active substances:
Ketamine
Estonian, English, Latin
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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