Cinacalcet Accordpharma (cinacalcet)
- Region
- 🇪🇺 EU
- Active substance
- cinacalcet
- Company
- Accord Healthcare S.L.U.
- Status
- Authorised
- Therapeutic area
- Hyperparathyroidism
- CHMP opinion
- Thu 30 Jan 2020
- EU approval
- Fri 03 Apr 2020
- Designations
- Generic
- Application
- EMEA/H/C/005236
- ATC
- H05BX01
- Official record
- www.ema.europa.eu
Indication
Secondary hyperparathyroidism AdultsTreatment of secondary hyperparathyroidism (HPT) in adult patients with end-stage renal disease (ESRD) on maintenance dialysis therapy. Paediatric populationTreatment 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 Accordpharma 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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Mimpara Withdrawn · Amgen Europe B.V.
- 🇪🇺 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- 🇪🇺 Parareg Withdrawn · Dompé Biotec S.p.A.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.