Product class:
|
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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1213018
|
Name of medicinal product:
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APROVEL
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Active substances:
|
|
ATC code:
|
C09CA04
|
Dosage form:
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film-coated tablet
|
Route of administration:
|
oral use
|
Strengh:
|
150mg
|
Amount in package:
|
56TK
|
Legal status for supply*:
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Subject to medicinal prescription
|
Class of active substance:
|
|
Additional information:
|
|
Indication:
|
Aprovel is indicated in adults for the treatment of essential hypertension.
It is also indicated for the treatment of renal disease in adult patients with hypertension and type 2
diabetes mellitus as part of an antihypertensive medicinal product regimen (see sections 4.3, 4.4, 4.5
and 5.1).
|
Safety features:
|
Yes
|
Summary of product characteristics (SPC):
|
|
Package information leaflet (PIL):
|
EST
|
Labelling:
|
|
Last imported to Estonia:
|
Never imported to Estonia
|
Marketing authorization holder:
|
Sanofi Winthrop Industrie
|
Marketing authorization number:
|
EU/1/97/046
|
Marketing authorization issued on:
|
March 2, 2004
|
Marketing authorization expires on:
|
Unlimited
|
Marketing authorization procedure type:
|
Centralised
|
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 14, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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