Parareg (cinacalcet)
- Region
- 🇪🇺 EU
- Active substance
- cinacalcet
- Company
- Dompé Biotec S.p.A.
- Status
- Withdrawn
- Therapeutic area
- Hypercalcemia; Parathyroid Neoplasms; Hyperparathyroidism
- EU approval
- Fri 22 Oct 2004
- Application
- EMEA/H/C/000575
- ATC
- H05BX01
- Official record
- www.ema.europa.eu
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 calciumlevels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Cinacalcet Accordpharma Authorised · Accord Healthcare S.L.U.
- 🇪🇺 Mimpara Withdrawn · Amgen Europe B.V.
- 🇪🇺 Cinacalcet Viatris (previously Cinacalcet Mylan) Authorised · Mylan Pharmaceuticals Limited
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.