Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1824500
Name of medicinal product: DEXMEDETOMIDINE AUXILIA
Active substances:
Estonian, English, Latin
ATC code: N05CM18
Dosage form: concentrate for solution for infusion
Route of administration: intravenous use
Strengh: 100mcg 1ml
Amount in package: 4ml 4TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Safety features: Yes
Summary of product characteristics (SPC):  (last updated April 12, 2022)
Package information leaflet (PIL): EST  (last updated April 12, 2022)
Labelling:  (last updated October 4, 2021)
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Auxilia Pharma OÜ 
Marketing authorization number: 1042321 
Marketing authorization issued on: October 4, 2021 
Marketing authorization expires on: October 4, 2026 
Marketing authorization procedure type: National 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Description Additional condition
Ei ole lubatud väljastada korduvretsepti
Hambaarstil on õigus välja kirjutada Väikseima müügiloleva ravimpakendi suuruses, kuid mitte üle 20 tableti
Entry/Changing date: April 11, 2022
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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