Parsabiv (etelcalcetide)
- Region
- 🇪🇺 EU
- Active substance
- etelcalcetide
- Company
- Amgen Europe B.V.
- Status
- Authorised
- Therapeutic area
- Hyperparathyroidism, Secondary
- CHMP opinion
- Thu 15 Sep 2016
- EU approval
- Fri 11 Nov 2016
- Application
- EMEA/H/C/003995
- ATC
- H05BX04
- Official record
- www.ema.europa.eu
Indication
Parsabiv is indicated for the treatment of secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) on haemodialysis therapy.
Regulatory milestones
No milestones recorded in the last year.
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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.