Register of Medicinal Products

AMALORIS

Product class:	Authorized package
Medicinal product class:	For human use
Package code:	1615496
Name of medicinal product:	AMALORIS
Active substances:	Atorvastatin+Amlodipine Estonian, English, Latin
ATC code:	C10BX03
Dosage form:	film-coated tablet
Route of administration:	oral use
Strengh:	10mg+5mg
Amount in package:	50TK
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 November 29, 2022)
Package information leaflet (PIL):	EST (last updated November 29, 2022)
Labelling:	(last updated June 21, 2022)
Last imported to Estonia:	Never imported to Estonia

Marketing authorization

Marketing authorization holder:	KRKA d.d. Novo mesto
Marketing authorization number:	845714
Marketing authorization issued on:	May 26, 2014
Marketing authorization expires on:	Unlimited
Marketing authorization procedure type:	Decentralised

Reference price:
Under reference price:
Reference price of daily dose:

Perscription conditions and restrictions

Description	Additional condition
Perearsti õel on õigus välja kirjutada	Välja arvatud esmane retsept

Entry/Changing date: May 8, 2023

Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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