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Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1815713
Name of medicinal product: CINACALCET ACCORDPHARMA
Active substances:
Cinacalcet
Estonian, English, Latin
ATC code: H05BX01
Dosage form: film-coated tablet
Route of administration: oral use
Strengh: 90mg
Amount in package: 28TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: 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 3 years 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). Cinacalcet Accordpharma 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.
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: August 27, 2020
Marketing authorization holder: Accord Healthcare S.L.U. 
Marketing authorization number: EU/1/20/1429 
Marketing authorization issued on: April 3, 2020 
Marketing authorization expires on: April 7, 2025 
Marketing authorization procedure type: Centralised 
Percent Valid from Valid until Valid Diagnosis Doctor's speciality Primary Age Other
50  04.07.2022  01.10.2022  Yes      No      
100  04.07.2022  01.10.2022  Yes  N18-N18  Pediaater, Nefroloog  No  until 4 years  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 
100  04.07.2022  01.10.2022  Yes      No  until 4 years   
100  04.07.2022  01.10.2022  Yes  N18-N18  Pediaater, Nefroloog  No     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 
Reference price: 256,20 EUR 
Under reference price: Yes 
Reference price of daily dose: 6,10 EUR 
Entry/Changing date: April 9, 2020
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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