Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: AMALORIS
Active substances:
Estonian, English, Latin
ATC code: C10BX03
Dosage form: film-coated tablet
Strength: 10mg+10mg
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):  (last updated November 29, 2022)
Package information leaflet (PIL): EST  (last updated November 29, 2022)
Labelling:  (last updated June 21, 2022)
Indication: is indicated for prevention of cardiovascular events in hypertensive patients, with three concomitant cardiovascular risk factors, normal to mildly elevated cholesterol levels, without clinically evident coronary heart disease where combined use of amlodipine and a low dose of atorvastatin is considered appropriate, in accordance with current treatment guidelines (see section 5.1). should be used when response to diet and other non-pharmacological measures is inadequate.
Safety features: Yes
Marketing authorization holder: KRKA, d.d., Novo mesto 
Marketing authorization number: 811513 
Marketing authorization issued on: March 28, 2013 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Decentralised 
Assessment report:  (last updated December 19, 2013) 
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
1565782  AMALORIS  film-coated tablet  10mg +10mg 10TK  Prescription           
1565793  AMALORIS  film-coated tablet  10mg +10mg 14TK  Prescription           
1565805  AMALORIS  film-coated tablet  10mg +10mg 20TK  Prescription           
1565816  AMALORIS  film-coated tablet  10mg +10mg 28TK  Prescription           
1565827  AMALORIS  film-coated tablet  10mg +10mg 30TK  Prescription           
1565838  AMALORIS  film-coated tablet  10mg +10mg 50TK  Prescription           
1565849  AMALORIS  film-coated tablet  10mg +10mg 56TK  Prescription           
1565850  AMALORIS  film-coated tablet  10mg +10mg 60TK  Prescription           
1565861  AMALORIS  film-coated tablet  10mg +10mg 90TK  Prescription           
1565872  AMALORIS  film-coated tablet  10mg +10mg 100TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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