Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: APROVEL
Active substances:
Irbesartan
Estonian, English, Latin
ATC code: C09CA04
Dosage form: film-coated tablet
Strength: 300mg
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
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
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 
Assessment report:   
Description Additional condition
Perearsti õel on õigus välja kirjutada Välja arvatud esmane retsept
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1213030  APROVEL  film-coated tablet  300mg 14TK  Prescription           
1213041  APROVEL  film-coated tablet  300mg 28TK  Prescription      20.05.2011     
1213052  APROVEL  film-coated tablet  300mg 56TK  Prescription           
1213063  APROVEL  film-coated tablet  300mg 98TK  Prescription           
1308248  APROVEL  film-coated tablet  300mg 84TK  Prescription           
1308259  APROVEL  film-coated tablet  300mg 30TK  Prescription           
1308260  APROVEL  film-coated tablet  300mg 90TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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