Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: CINACALCET MYLAN
Active substances:
Cinacalcet
Estonian, English, Latin
ATC code: H05BX01
Dosage form: film-coated tablet
Strength: 90mg
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
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
Marketing authorization holder: Mylan Pharmaceuticals Limited 
Marketing authorization number: EU/1/15/1054 
Marketing authorization issued on: November 23, 2015 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported Additional information
1703898  CINACALCET MYLAN  film-coated tablet  90mg 28TK  Prescription         
1703900  CINACALCET MYLAN  film-coated tablet  90mg 30TK  Prescription         
1820810  CINACALCET MYLAN  film-coated tablet  90mg 84TK  Prescription         
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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