Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: DEXMEDETOMIDINE ACCORD
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: Accord Healthcare S.L.U. 
Marketing authorization number: EU/1/19/1418 
Marketing authorization issued on: February 13, 2020 
Marketing authorization expires on: February 17, 2025 
Marketing authorization procedure type: Centralised 
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
1811258  DEXMEDETOMIDINE ACCORD  concentrate for solution for infusion  100mcg 1ml 2ml 1TK  Prescription           
1811269  DEXMEDETOMIDINE ACCORD  concentrate for solution for infusion  100mcg 1ml 2ml 4TK  Prescription           
1811270  DEXMEDETOMIDINE ACCORD  concentrate for solution for infusion  100mcg 1ml 2ml 5TK  Prescription           
1811281  DEXMEDETOMIDINE ACCORD  concentrate for solution for infusion  100mcg 1ml 2ml 25TK  Prescription      11.07.2022     
1811292  DEXMEDETOMIDINE ACCORD  concentrate for solution for infusion  100mcg 1ml 4ml 1TK  Prescription           
1811304  DEXMEDETOMIDINE ACCORD  concentrate for solution for infusion  100mcg 1ml 4ml 4TK  Prescription      09.08.2022     
1811315  DEXMEDETOMIDINE ACCORD  concentrate for solution for infusion  100mcg 1ml 4ml 5TK  Prescription           
1811326  DEXMEDETOMIDINE ACCORD  concentrate for solution for infusion  100mcg 1ml 10ml 1TK  Prescription           
1811337  DEXMEDETOMIDINE ACCORD  concentrate for solution for infusion  100mcg 1ml 10ml 4TK  Prescription           
1811348  DEXMEDETOMIDINE ACCORD  concentrate for solution for infusion  100mcg 1ml 10ml 5TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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