Product class:
|
Authorized package
|
Medicinal product class:
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For human use
|
Package code:
|
1190034
|
Name of medicinal product:
|
AMPRIL 5 MG
|
Active substances:
|
|
ATC code:
|
C09AA05
|
Dosage form:
|
tablet
|
Route of administration:
|
oral use
|
Strengh:
|
5mg
|
Amount in package:
|
30TK
|
Legal status for supply*:
|
Subject to medicinal prescription
|
Class of active substance:
|
|
Additional information:
|
|
Indication:
|
Treatment of hypertension:
Cardiovascular prevention: reduction of cardiovascular morbidity and mortality in patients with:
- manifest atherothrombotic cardiovascular disease (history of coronary heart disease or stroke, or peripheral vascular disease) or
- diabetes with at least one cardiovascular risk factor.
Treatment of renal disease:
- Incipient glomerular diabetic nephropathy as defined by the presence of microalbuminuria.
- Manifest glomerular diabetic nephropathy as defined by macroproteinuria in patients with at least one cardiovascular risk factor (see section 5.1).
- Manifest glomerular non diabetic nephropathy as defined by macroproteinuria ? 3 g/day (see section 5.1).
Treatment of symptomatic heart failure.
Secondary prevention after acute myocardial infarction: reduction of mortality from the acute phase of myocardial infarction in patients with clinical signs of heart failure, when started >48 hours following acute myocardial infarction.
|
Safety features:
|
Yes
|
Summary of product characteristics (SPC):
|
(last updated September 27, 2019)
|
Package information leaflet (PIL):
|
EST (last updated September 27, 2019)
|
Translation of package information leaflet into Russian:
|
RUS (last updated September 27, 2019)
|
Translation of package information leaflet into English:
|
ENG (last updated September 27, 2019)
|
Labelling:
|
(last updated September 27, 2019)
|
Last imported to Estonia:
|
November 13, 2023
|
Marketing authorization holder:
|
KRKA, d.d., Novo mesto
|
Marketing authorization number:
|
496705
|
Marketing authorization issued on:
|
November 11, 2005
|
Marketing authorization expires on:
|
Unlimited
|
Marketing authorization procedure type:
|
Mutual recognition
|
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
|
|
|
100
|
01.01.2024
|
01.04.2024
|
Yes
|
I15-I15; I50-I50; I10-I13
|
|
No
|
until 4 years
|
|
75
|
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
|
|
90
|
01.01.2024
|
01.04.2024
|
Yes
|
I15-I15; I50-I50; I10-I13
|
|
No
|
4 years - 17 years
|
|
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
|
|
Reference price:
|
2,40 EUR
|
Under reference price:
|
No
|
Reference price of daily dose:
|
0,04 EUR
|
Description
|
Additional condition
|
Perearsti õel on õigus välja kirjutada
|
Välja arvatud esmane retsept
|
Entry/Changing date:
October 26, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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