Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1213041
Name of medicinal product: APROVEL
Active substances:
Irbesartan
Estonian, English, Latin
ATC code: C09CA04
Dosage form: film-coated tablet
Route of administration: oral use
Strengh: 300mg
Amount in package: 28TK
Legal status for supply*: 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: May 20, 2011
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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