Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: DEXMEDETOMIDINE KABI
Active substances:
Dexmedetomidine
Estonian, English, Latin
ATC code: N05CM18
Dosage form: concentrate for solution for infusion
Strength: 100mcg 1ml
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):  (last updated January 13, 2023)
Package information leaflet (PIL): EST  (last updated January 13, 2023)
Labelling:  (last updated September 15, 2021)
Indication: For sedation of adult ICU (Intensive Care Unit) patients requiring a sedation level not deeper than arousal in response to verbal stimulation (corresponding to Richmond Agitation-Sedation Scale (RASS) 0 to -3). For sedation of non-intubated adult patients prior to and/or during diagnostic or surgical procedures requiring sedation, i.e. procedural/awake sedation.
Safety features: Yes
Marketing authorization holder: Fresenius Kabi Polska Sp. z o.o. 
Marketing authorization number: 1038821 
Marketing authorization issued on: September 15, 2021 
Marketing authorization expires on: September 15, 2026 
Marketing authorization procedure type: Decentralised 
Assessment report:   
Description Additional condition
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Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1829392  DEXMEDETOMIDINE KABI  concentrate for solution for infusion  100mcg 1ml 2ml 10TK  Prescription           
1829404  DEXMEDETOMIDINE KABI  concentrate for solution for infusion  100mcg 1ml 2ml 25TK  Prescription           
1829415  DEXMEDETOMIDINE KABI  concentrate for solution for infusion  100mcg 1ml 4ml 1TK  Prescription           
1829426  DEXMEDETOMIDINE KABI  concentrate for solution for infusion  100mcg 1ml 4ml 4TK  Prescription           
1829437  DEXMEDETOMIDINE KABI  concentrate for solution for infusion  100mcg 1ml 4ml 10TK  Prescription      01.04.2024     
1829448  DEXMEDETOMIDINE KABI  concentrate for solution for infusion  100mcg 1ml 10ml 4TK  Prescription           
1829459  DEXMEDETOMIDINE KABI  concentrate for solution for infusion  100mcg 1ml 10ml 10TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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