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Product class:
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Authorized package
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Medicinal product class:
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For human use
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Package code:
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1044616
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Name of medicinal product:
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AMIOKORDIN
|
|
Active substances:
|
|
|
ATC code:
|
C01BD01
|
|
Dosage form:
|
tablet
|
|
Route of administration:
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oral use
|
|
Strengh:
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200mg
|
|
Amount in package:
|
60TK
|
|
Legal status for supply*:
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Subject to medicinal prescription
|
|
Class of active substance:
|
|
|
Additional information:
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|
|
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.
|
|
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 August 31, 2020)
|
|
Last imported to Estonia:
|
November 27, 2023
|
|
Marketing authorization holder:
|
KRKA d.d. Novo mesto
|
|
Marketing authorization number:
|
438904
|
|
Marketing authorization issued on:
|
March 26, 2004
|
|
Marketing authorization expires on:
|
Unlimited
|
|
Marketing authorization procedure type:
|
National
|
|
Percent
|
Valid from
|
Valid until
|
Valid
|
Diagnosis
|
Doctor's speciality
|
Primary
|
Age
|
Other
|
|
90
|
24.10.2023
|
|
Yes
|
I47-I49
|
Kardioloog, Pediaater
|
Yes
|
|
|
|
75
|
24.10.2023
|
|
Yes
|
I47-I49
|
Kardioloog, Pediaater
|
Yes
|
|
|
|
90
|
24.10.2023
|
|
Yes
|
I47-I49
|
Kardioloog, Pediaater
|
Yes
|
from 63 years
|
|
|
50
|
24.10.2023
|
|
Yes
|
|
|
No
|
|
|
|
100
|
24.10.2023
|
|
Yes
|
I47-I49
|
Kardioloog, Pediaater
|
Yes
|
until 4 years
|
|
|
100
|
24.10.2023
|
|
Yes
|
|
|
No
|
until 4 years
|
|
|
90
|
24.10.2023
|
|
Yes
|
I47-I49
|
Kardioloog, Pediaater
|
Yes
|
4 years - 17 years
|
|
|
90
|
24.10.2023
|
|
Yes
|
I47-I49
|
Kardioloog, Pediaater
|
Yes
|
|
|
|
Reference price:
|
6,60 EUR
|
|
Under reference price:
|
Yes
|
|
Reference price of daily dose:
|
0,11 EUR
|
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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