Mimpara (cinacalcet)
- Region
- 🇪🇺 EU
- Active substance
- cinacalcet
- Company
- Amgen Europe B.V.
- Status
- Withdrawn
- Therapeutic area
- Hypercalcemia; Parathyroid Neoplasms; Hyperparathyroidism
- EU approval
- Fri 22 Oct 2004
- Application
- EMEA/H/C/000570
- ATC
- H05BX01
- Official record
- www.ema.europa.eu
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. Mimpara may be used as part of a therapeutic regimen including phosphate binders and/or Vitamin D sterols, as appropriate. 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.
Regulatory milestones
Mimpara: medicine discontinued
Tablet, Granules in capsule; Alternatives available: Yes · source
Same substance in other markets
- 🇪🇺 Cinacalcet Accordpharma Authorised · Accord Healthcare S.L.U.
- 🇪🇺 Cinacalcet Viatris (previously Cinacalcet Mylan) Authorised · Mylan Pharmaceuticals Limited
- 🇪🇺 Parareg Withdrawn · Dompé Biotec S.p.A.
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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.