This is a summary of the European public assessment report (EPAR) for Cinacalcet Mylan. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Cinacalcet Mylan. For practical information about using Cinacalcet Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Therapeutic Indication
### Therapeutic 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. 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.
Therapeutic Area (MeSH)
N/AATC Code
H05BX01
ATC Item
cinacalcet
Pharmacotherapeutic Group
Calcium homeostasis
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| cinacalcet hydrochloride | N/A | 西那卡塞 |
EMA Name
Cinacalcet Mylan
Medicine Name
Cinacalcet Mylan
Aliases
N/ANo risk management plan link.
