Product class: Authorized package
Medicinal product class: For human use
Package code: 1615441
Name of medicinal product: AMALORIS
Active substances:
Estonian, English, Latin
ATC code: C10BX03
Dosage form: film-coated tablet
Route of administration: oral use
Strengh: 10mg+5mg
Amount in package: 10TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
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
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)
Last imported to Estonia: Never imported to Estonia
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 
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: 30 October 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription