Cinacalcet Viatris (previously Cinacalcet Mylan) (cinacalcet)
- Region
- 🇪🇺 EU
- Active substance
- cinacalcet
- Company
- Mylan Pharmaceuticals Limited
- Status
- Authorised
- Therapeutic area
- Hyperparathyroidism, Secondary; Hypercalcemia
- CHMP opinion
- Thu 24 Sep 2015
- EU approval
- Thu 19 Nov 2015
- Designations
- Generic
- Application
- EMEA/H/C/004014
- 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. 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.
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- 🇪🇺 Mimpara Withdrawn · Amgen Europe B.V.
- 🇪🇺 Parareg Withdrawn · Dompé Biotec S.p.A.
Follow Cinacalcet Viatris (previously Cinacalcet Mylan)
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
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.