Product class:
|
Authorized package
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Medicinal product class:
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For human use
|
Package code:
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1502334
|
Name of medicinal product:
|
CARDACE
|
Active substances:
|
|
ATC code:
|
C09AA05
|
Dosage form:
|
tablet
|
Route of administration:
|
oral use
|
Strengh:
|
10mg
|
Amount in package:
|
50TK
|
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:
o manifest atherothrombotic cardiovascular disease (history of coronary heart disease or
stroke, or peripheral vascular disease) or
o diabetes with at least one cardiovascular risk factor (see section 5.1).
- Treatment of renal disease:
o Incipient glomerular diabetic nephropathy as defined by the presence of
microalbuminuria,
o Manifest glomerular diabetic nephropathy as defined by macroproteinuria in patients
with at least one cardiovascular risk factor (see section 5.1),
o 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 June 20, 2023)
|
Package information leaflet (PIL):
|
EST (last updated June 20, 2023)
|
Translation of package information leaflet into Russian:
|
RUS (last updated December 20, 2021)
|
Translation of package information leaflet into English:
|
ENG (last updated December 20, 2021)
|
Labelling:
|
(last updated June 20, 2023)
|
Last imported to Estonia:
|
Never imported to Estonia
|
Marketing authorization holder:
|
Sanofi Winthrop Industrie
|
Marketing authorization number:
|
384202
|
Marketing authorization issued on:
|
June 7, 2002
|
Marketing authorization expires on:
|
Unlimited
|
Marketing authorization procedure type:
|
Mutual recognition
|
Reference price:
|
|
Under reference price:
|
|
Reference price of daily dose:
|
|
Description
|
Additional condition
|
Perearsti õel on õigus välja kirjutada
|
Välja arvatud esmane retsept
|
Entry/Changing date:
February 19, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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