Product class: Authorized package
Medicinal product class: For human use
Package code: 1703898
Name of medicinal product: CINACALCET MYLAN
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: Treatment of secondary hyperparathyroidism (HPT) in patients with end-stage renal disease (ESRD) on maintenance dialysis therapy. Cinacalcet Mylan may be used as part of a therapeutic regimen including phosphate binders and/or vitamin D sterols, as appropriate (see section 5.1). Reduction of hypercalcaemia in 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: Never imported to Estonia
Marketing authorization holder: Mylan Pharmaceuticals Limited 
Marketing authorization number: EU/1/15/1054 
Marketing authorization issued on: 23 November 2015 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: 26 October 2021
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription