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Active Substance: cinacalcet
Common Name: cinacalcet
ATC Code: H05BX01
Marketing Authorisation Holder: Dompé Biotec S.p.A.
Active Substance: cinacalcet
Status: Withdrawn
Authorisation Date: 2004-10-22
Therapeutic Area: Parathyroid Neoplasms Hypercalcemia Hyperparathyroidism
Pharmacotherapeutic Group: Calcium homeostasis

Therapeutic Indication

Treatment of secondary hyperparathyroidism (HPT) in patients with end-stage renal disease (ESRD) on maintenance dialysis therapy.
Mimpara 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.

The marketing authorisation for Parareg has been withdrawn at the request of the marketing authorisation holder.

Source: European Medicines Agency

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