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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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1087871
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Name of medicinal product:
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AMLOCARD 5 MG
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Active substances:
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ATC code:
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C08CA01
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Dosage form:
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tablet
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Route of administration:
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oral use
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|
Strengh:
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5mg
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Amount in package:
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30TK
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|
Legal status for supply*:
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Subject to medicinal prescription
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Class of active substance:
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|
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Additional information:
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|
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Indication:
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Hypertension
Chronic stable angina pectoris
Vasospastic (Prinzmetal's) angina
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|
Safety features:
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Yes
|
|
Summary of product characteristics (SPC):
|
 (last updated November 2, 2020)
|
|
Package information leaflet (PIL):
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EST (last updated November 2, 2020)
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|
Translation of package information leaflet into Russian:
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RUS (last updated November 2, 2020)
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Translation of package information leaflet into English:
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ENG (last updated November 2, 2020)
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Labelling:
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(last updated November 2, 2020)
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Last imported to Estonia:
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June 14, 2017
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Marketing authorization holder:
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Hexal AG
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Marketing authorization number:
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538507
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Marketing authorization issued on:
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February 12, 2007
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Marketing authorization expires on:
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Unlimited
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Marketing authorization procedure type:
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Mutual recognition
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Percent
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Valid from
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Valid until
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Valid
|
Diagnosis
|
Doctor's speciality
|
Primary
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Age
|
Other
|
|
90
|
01.07.2023
|
|
Yes
|
I15-I15; I10-I13; I20-I20
|
|
No
|
from 63 years
|
|
|
90
|
01.07.2023
|
|
Yes
|
I15-I15; I10-I13; I20-I20
|
|
No
|
|
|
|
90
|
01.07.2023
|
|
Yes
|
I15-I15; I10-I13; I20-I20
|
|
No
|
|
|
|
90
|
01.07.2023
|
|
Yes
|
I15-I15; I10-I13; I20-I20
|
|
No
|
4 years - 17 years
|
|
|
100
|
01.07.2023
|
|
Yes
|
|
|
No
|
until 4 years
|
|
|
50
|
01.07.2023
|
|
Yes
|
|
|
No
|
|
|
|
75
|
01.07.2023
|
|
Yes
|
I15-I15; I10-I13; I20-I20
|
|
No
|
|
|
|
100
|
01.07.2023
|
|
Yes
|
I15-I15; I10-I13; I20-I20
|
|
No
|
until 4 years
|
|
|
Reference price:
|
1,20 EUR
|
|
Under reference price:
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No
|
|
Reference price of daily dose:
|
0,04 EUR
|
|
Description
|
Additional condition
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|
Perearsti õel on õigus välja kirjutada
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Välja arvatud esmane retsept
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Entry/Changing date:
April 25, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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