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.
Mimpara : EPAR - Summary for the public (PDF/87.38 KB)
First published: 20/11/2009
Last updated: 05/09/2017
Mimpara : EPAR - Risk-management-plan summary (PDF/108.96 KB)
First published: 22/08/2019
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Amgen Europe B.V.
|Date of issue of marketing authorisation valid throughout the European Union||
01/07/2019 Mimpara - EMEA/H/C/000570 - II/0062/G
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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.
Treatment of secondary hyperparathyroidism (HPT) in adult patients with end stage renal disease (ESRD) on maintenance dialysis therapy.
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 (see section 4.4).
Mimpara may be used as part of a therapeutic regimen including phosphate binders and/or Vitamin D sterols, as appropriate (see section 5.1).
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.