Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1667448
Name of medicinal product: CINACALCET TEVA
Active substances:
Cinacalcet
Estonian, English, Latin
ATC code: H05BX01
Dosage form: film-coated tablet
Route of administration: oral use
Strengh: 60mg
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). 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):  (last updated September 2, 2020)
Package information leaflet (PIL): EST  (last updated September 2, 2020)
Labelling:  (last updated September 2, 2020)
Last imported to Estonia: January 24, 2020
Marketing authorization holder: Teva B.V. 
Marketing authorization number: 903316 
Marketing authorization issued on: March 8, 2016 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Decentralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: January 10, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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