Mimpara

RSS

cinacalcet

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Mimpara. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Mimpara.

For practical information about using Mimpara, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 02/03/2020

Authorisation details

Product details
Name
Mimpara
Agency product number
EMEA/H/C/000570
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
Publication details
Marketing-authorisation holder
Amgen Europe B.V.
Revision
22
Date of issue of marketing authorisation valid throughout the European Union
22/10/2004
Contact address

Minervum 7061
NL-4817 ZK Breda
The Netherlands

Product information

23/01/2020 Mimpara - EMEA/H/C/000570 - II/0065

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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.

Assessment history

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