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Product class:
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Medicinal product with marketing authorization
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Medicinal product class:
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Human medicine
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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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Strength:
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10mg+10mg
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Legal status for supply*:
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Subject to medicinal prescription
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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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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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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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Assessment report:
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(last updated December 19, 2013)
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Description
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Additional condition
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Perearsti õel on õigus välja kirjutada
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Välja arvatud esmane retsept
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Package code
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Name of medicinal product
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Dosage form
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Package
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Legal status
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Reimbursements
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Reference price
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Last imported
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PƤritolumaa
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Additional information
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1565782
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AMALORIS
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film-coated tablet
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10mg +10mg 10TK
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Prescription
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1565793
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AMALORIS
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film-coated tablet
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10mg +10mg 14TK
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Prescription
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1565805
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AMALORIS
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film-coated tablet
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10mg +10mg 20TK
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Prescription
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1565816
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AMALORIS
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film-coated tablet
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10mg +10mg 28TK
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Prescription
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1565827
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AMALORIS
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film-coated tablet
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10mg +10mg 30TK
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Prescription
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1565838
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AMALORIS
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film-coated tablet
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10mg +10mg 50TK
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Prescription
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1565849
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AMALORIS
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film-coated tablet
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10mg +10mg 56TK
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Prescription
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1565850
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AMALORIS
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film-coated tablet
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10mg +10mg 60TK
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Prescription
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1565861
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AMALORIS
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film-coated tablet
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10mg +10mg 90TK
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Prescription
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1565872
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AMALORIS
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film-coated tablet
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10mg +10mg 100TK
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Prescription
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Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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