Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1112409
Name of medicinal product: AMIOKORDIN
Active substances:
Amiodarone
Estonian, English, Latin
ATC code: C01BD01
Dosage form: solution for injection
Route of administration: intravenous use
Strengh: 50mg 1ml
Amount in package: 3ml 5TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Paroxysmal supraventricular tachycardia (including Wolff-Parkinson-White syndrome), atrial fibrillation and flutter, ventricular tachyarrhythmias, when other drugs are ineffective, contraindicated or have caused severe adverese reactions. Note: Amiokordin solution for injection is used only when rapid response to treatment is required or when oral treatment is not possible.
Safety features: Yes
Summary of product characteristics (SPC):  (last updated March 28, 2022)
Package information leaflet (PIL): EST  (last updated March 28, 2022)
Labelling:  (last updated October 6, 2020)
Last imported to Estonia: November 27, 2023
Marketing authorization holder: KRKA d.d. Novo mesto 
Marketing authorization number: 418003 
Marketing authorization issued on: August 8, 2003 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: National 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: August 7, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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