Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: AMALORIS
Active substances:
Atorvastatin+Amlodipine
Estonian, English, Latin
ATC code: C10BX03
Dosage form: film-coated tablet
Strength: 10mg+5mg
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):  (last updated 29 November 2022)
Package information leaflet (PIL): EST  (last updated 29 November 2022)
Labelling:  (last updated 21 June 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: 845714 
Marketing authorization issued on: 26 May 2014 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Decentralised 
Assessment report:  (last updated 29 November 2022) 
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
1615441  AMALORIS  film-coated tablet  10mg +5mg 10TK  Prescription           
1615452  AMALORIS  film-coated tablet  10mg +5mg 14TK  Prescription           
1615463  AMALORIS  film-coated tablet  10mg +5mg 20TK  Prescription           
1615474  AMALORIS  film-coated tablet  10mg +5mg 28TK  Prescription           
1615485  AMALORIS  film-coated tablet  10mg +5mg 30TK  Prescription           
1615496  AMALORIS  film-coated tablet  10mg +5mg 50TK  Prescription           
1615508  AMALORIS  film-coated tablet  10mg +5mg 56TK  Prescription           
1615519  AMALORIS  film-coated tablet  10mg +5mg 60TK  Prescription           
1615520  AMALORIS  film-coated tablet  10mg +5mg 90TK  Prescription           
1615531  AMALORIS  film-coated tablet  10mg +5mg 100TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription