Product class: Authorized package
Medicinal product class: Veterinary medicine
Package code: 1735107
Name of medicinal product: Cepedex
Active substances:
Dexmedetomidine
Estonian, English, Latin
ATC code: QN05CM18
Dosage form: solution for injection
Route of administration: intramuscular use; intravenous use
Strengh: 0,5mg 1ml
Amount in package: 10ml 5TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Non-invasive, mildly to moderately painful, procedures and examinations which require restraint, sedation and analgesia in dogs and cats. Deep sedation and analgesia in dogs in concomitant use with butorphanol for medical and minor surgical procedures. Premedication in dogs and cats before induction and maintenance of general anaesthesia.
Safety features: No
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Withdrawal time: Ei rakendata.
Species: kass, koer
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: CP-Pharma Handelsgesellschaft mbH 
Marketing authorization number: EU/2/16/200 
Marketing authorization issued on: 13 December 2016 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Entry/Changing date: 02 May 2022
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription