Product class:
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Authorized package
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Medicinal product class:
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For human use
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Package code:
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1565827
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Name of medicinal product:
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AMALORIS
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Active substances:
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ATC code:
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C10BX03
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Dosage form:
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film-coated tablet
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Route of administration:
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oral use
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Strengh:
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10mg+10mg
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Amount in package:
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30TK
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Legal status for supply*:
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Subject to medicinal prescription
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Class of active substance:
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|
Additional information:
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Indication:
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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.
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Safety features:
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Yes
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Summary of product characteristics (SPC):
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(last updated November 29, 2022)
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Package information leaflet (PIL):
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EST (last updated November 29, 2022)
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Labelling:
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(last updated June 21, 2022)
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Last imported to Estonia:
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Never imported to Estonia
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Marketing authorization holder:
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KRKA, d.d., Novo mesto
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Marketing authorization number:
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811513
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Marketing authorization issued on:
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March 28, 2013
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Marketing authorization expires on:
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Unlimited
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Marketing authorization procedure type:
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Decentralised
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Reference price:
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Under reference price:
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Reference price of daily dose:
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Description
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Additional condition
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Perearsti õel on õigus välja kirjutada
|
Välja arvatud esmane retsept
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Entry/Changing date:
October 30, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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