Product class:
|
Authorized package
|
Medicinal product class:
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For human use
|
Package code:
|
1183867
|
Name of medicinal product:
|
ATACAND
|
Active substances:
|
|
ATC code:
|
C09CA06
|
Dosage form:
|
tablet
|
Route of administration:
|
oral use
|
Strengh:
|
32mg
|
Amount in package:
|
28TK
|
Legal status for supply*:
|
Subject to medicinal prescription
|
Class of active substance:
|
|
Additional information:
|
|
Indication:
|
Atacand is indicated for:
? The treatment of primary hypertension in adults.
? The treatment of hypertension in children and adolescents aged 6 to <18 years.
? The treatment of adult patients with heart failure and impaired left ventricular systolic function
(left ventricular ejection fraction ? 40%) when Angiotensin Converting Enzyme (ACE)-
inhibitors are not tolerated or as add-on therapy to ACE-inhibitors in patients with symptomatic
heart failure, despite optimal therapy, when mineralocorticoid receptor antagonists are not
tolerated (see sections 4.2, 4.4, 4.5 and 5.1).
|
Safety features:
|
Yes
|
Summary of product characteristics (SPC):
|
(last updated November 15, 2023)
|
Package information leaflet (PIL):
|
EST (last updated December 11, 2023)
|
Labelling:
|
(last updated November 15, 2023)
|
Last imported to Estonia:
|
September 15, 2023
|
Marketing authorization holder:
|
Cheplapharm Arzneimittel GmbH
|
Marketing authorization number:
|
511306
|
Marketing authorization issued on:
|
March 30, 2006
|
Marketing authorization expires on:
|
Unlimited
|
Marketing authorization procedure type:
|
Decentralised
|
Percent
|
Valid from
|
Valid until
|
Valid
|
Diagnosis
|
Doctor's speciality
|
Primary
|
Age
|
Other
|
90
|
01.01.2024
|
01.04.2024
|
Yes
|
I15-I15; I50-I50; I10-I13
|
|
No
|
4 years - 17 years
|
|
75
|
01.01.2024
|
01.04.2024
|
Yes
|
I15-I15; I50-I50; I10-I13
|
|
No
|
|
|
50
|
01.01.2024
|
01.04.2024
|
Yes
|
|
|
No
|
|
|
90
|
01.01.2024
|
01.04.2024
|
Yes
|
I15-I15; I50-I50; I10-I13
|
|
No
|
|
|
100
|
01.01.2024
|
01.04.2024
|
Yes
|
|
|
No
|
until 4 years
|
|
90
|
01.01.2024
|
01.04.2024
|
Yes
|
I15-I15; I50-I50; I10-I13
|
|
No
|
|
|
90
|
01.01.2024
|
01.04.2024
|
Yes
|
I15-I15; I50-I50; I10-I13
|
|
No
|
from 63 years
|
|
100
|
01.01.2024
|
01.04.2024
|
Yes
|
I15-I15; I50-I50; I10-I13
|
|
No
|
until 4 years
|
|
Reference price:
|
7,84 EUR
|
Under reference price:
|
No
|
Reference price of daily dose:
|
0,07 EUR
|
Description
|
Additional condition
|
Perearsti õel on õigus välja kirjutada
|
Välja arvatud esmane retsept
|
Entry/Changing date:
December 11, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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