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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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1667538
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Name of medicinal product:
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CINACALCET ACCORD
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Active substances:
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ATC code:
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H05BX01
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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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30mg
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Amount in package:
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28TK
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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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Secondary hyperparathyroidism
Adults
Treatment of secondary hyperparathyroidism (HPT) in adult patients with end-stage renal disease (ESRD) on maintenance dialysis therapy.
Paediatric population
Treatment of secondary hyperparathyroidism (HPT) in children aged 3years and older with end?stage renal disease (ESRD) on maintenance dialysis therapy in whom secondary HPT is not adequately controlled with standard of care therapy (see section 4.4).
may be used as part of a therapeutic regimen including phosphate binders and/or Vitamin D sterols, as appropriate (see section 5.1).
Parathyroid carcinoma and primary hyperparathyroidism in adults
Reduction of hypercalcaemia in adult patients with:
• parathyroid carcinoma.
• primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.
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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 March 3, 2021)
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Package information leaflet (PIL):
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EST (last updated May 21, 2020)
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Labelling:
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(last updated March 20, 2019)
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Last imported to Estonia:
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March 11, 2022
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Marketing authorization holder:
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Accord Healthcare B.V.
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Marketing authorization number:
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892315
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Marketing authorization issued on:
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November 11, 2015
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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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Percent
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Valid from
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Valid until
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Valid
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Diagnosis
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Doctor's speciality
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Primary
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Age
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Other
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100
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01.04.2023
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Yes
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N18-N18
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Nefroloog, Pediaater
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No
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hemo- või peritoneaaldialüüsil olevatele patsientidele, kelle ravi vitamiin D analoogidega on ebaõnnestunud (seerumi parathormooni taseme eesmärkväärtust <=300 pg/ml ei saavutata) või kellele on vitamiin D analoogid vastunäidustatud
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100
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01.04.2023
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Yes
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No
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until 4 years
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100
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01.04.2023
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Yes
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N18-N18
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Pediaater, Nefroloog
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No
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until 4 years
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hemo- või peritoneaaldialüüsil olevatele patsientidele, kelle ravi vitamiin D analoogidega on ebaõnnestunud (seerumi parathormooni taseme eesmärkväärtust <=300 pg/ml ei saavutata) või kellele on vitamiin D analoogid vastunäidustatud
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50
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01.04.2023
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Yes
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No
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Reference price:
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85,40 EUR
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Under reference price:
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No
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Reference price of daily dose:
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6,10 EUR
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Entry/Changing date:
March 3, 2021
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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