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: 30mg
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
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 Mylan 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: 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
1703843  CINACALCET MYLAN  film-coated tablet  30mg 28TK  Prescription         
1703854  CINACALCET MYLAN  film-coated tablet  30mg 30TK  Prescription         
1703865  CINACALCET MYLAN  film-coated tablet  30mg 100TK  Prescription         
1820797  CINACALCET MYLAN  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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