Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: CINACALCET ACCORD
Active substances:
Cinacalcet
Estonian, English, Latin
ATC code: H05BX01
Dosage form: film-coated tablet
Strength: 30mg
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):  (last updated March 3, 2021)
Package information leaflet (PIL): EST  (last updated May 21, 2020)
Labelling:  (last updated March 20, 2019)
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 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.
Safety features: Yes
Marketing authorization holder: Accord Healthcare B.V. 
Marketing authorization number: 892315 
Marketing authorization issued on: November 11, 2015 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Decentralised 
Assessment report:  (last updated November 18, 2015) 
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1667527  CINACALCET ACCORD  film-coated tablet  30mg 14TK  Prescription           
1667538  CINACALCET ACCORD  film-coated tablet  30mg 28TK  Prescription  100% 50%  85,40  31.10.2023     
1667549  CINACALCET ACCORD  film-coated tablet  30mg 84TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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