Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: DEXDOR
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):
Package information leaflet (PIL): EST
Labelling:  
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: Orion Corporation 
Marketing authorization number: EU/1/11/718 
Marketing authorization issued on: September 16, 2011 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Assessment report:   
Description Additional condition
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Hambaarstil on õigus välja kirjutada Väikseima müügiloleva ravimpakendi suuruses, kuid mitte üle 20 tableti
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1540336  DEXDOR  concentrate for solution for infusion  100mcg 1ml 2ml 5TK  Prescription      04.11.2013     
1540347  DEXDOR  concentrate for solution for infusion  100mcg 1ml 2ml 25TK  Prescription      28.09.2022     
1540358  DEXDOR  concentrate for solution for infusion  100mcg 1ml 4ml 4TK  Prescription      04.05.2022     
1540369  DEXDOR  concentrate for solution for infusion  100mcg 1ml 10ml 4TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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