Mimpara

Withdrawn

This medicine's authorisation has been withdrawn

cinacalcet

Overview

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.

Mimpara : EPAR - Summary for the public

Mimpara : EPAR - Risk-management-plan

Product information

Mimpara : EPAR - Product Information

Mimpara : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Mimpara
• Active substance:
  cinacalcet hydrochloride
• International non-proprietary name (INN) or common name:
  cinacalcet
• Therapeutic area (MeSH):
  • Hypercalcemia
  • Parathyroid Neoplasms
  • Hyperparathyroidism
• Anatomical therapeutic chemical (ATC) code:
  H05BX01

Pharmacotherapeutic group

Calcium homeostasis

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.

Authorisation details

• EMA product number:
  EMEA/H/C/000570
• Marketing authorisation holder:
  Amgen Europe B.V.

  Minervum 7061; NL-4817 ZK Breda; The Netherlands

• Marketing authorisation issued:
  22/10/2004
• Withdrawal of marketing authorisation:
  18/12/2025
• Revision:
  27

Assessment history

Changes since initial authorisation of medicine

Mimpara : EPAR - Procedural steps taken and scientific information after authorisation

Mimpara : EPAR - Divergent position of CHMP

Mimpara-H-C-570-X-0055-G : EPAR - Assessment Report - Extension

Adopted Reference Number: EMA/449274/2017

CHMP post-authorisation summary of positive opinion for Mimpara (X-55-G)

Reference Number: EMA/CHMP/379833/2017

CHMP post-authorisation summary of positive opinion for Mimpara on 24 April 2008

Adopted Reference Number: EMEA/CHMP/206457/2008

Mimpara-H-C-570-II-0010 : EPAR - Assessment Report - Variation

Reference Number: EMEA/365368/2008

Initial marketing authorisation documents

Mimpara : EPAR - Procedural steps taken before authorisation

Mimpara : EPAR - Scientific Discussion