Table of contents
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/93.39 KB)
First published: 22/08/2019
Last updated: 10/01/2022
|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||
29/12/2022 Mimpara - EMEA/H/C/000570 - N/0073
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.
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.