On 18 December 2025, the European Commission withdrew the marketing authorisation for Mimpara (cinacalcet) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Amgen Europe B.V., which notified the European Commission of its decision not to market the medicine in the EU for commercial reasons. Mimpara was granted marketing authorisation in the EU on 22 October 2004 for the treatment of secondary hyperparathyroidism and hypercalcaemia. There are other generic medicines of cinacalcet authorised and marketed in the EU.
Therapeutic Indication
### Therapeutic 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.
Therapeutic Area (MeSH)
ATC Code
H05BX01
ATC Item
cinacalcet
Pharmacotherapeutic Group
Calcium homeostasis
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| cinacalcet hydrochloride | N/A | 西那卡塞 |
EMA Name
Mimpara
Medicine Name
Mimpara
Aliases
N/A
