Mimpara

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Questions & Answers

On 22 June 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Mimpara. The marketing authorisation holder for this medicinal product is Amgen Europe B.V.

The CHMP adopted a change to the existing indication as follows1:

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 (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.”

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.


1New text in bold

Name Language First published Last updated
CHMP post-authorisation summary of positive opinion for Mimpara (X-55-G) (English only) 2017-06-23  

Key facts

Product details for Mimpara
NameMimpara
INN or common name

cinacalcet

Therapeutic area Parathyroid NeoplasmsHypercalcemiaHyperparathyroidism
Active substance

cinacalcet

Date opinion adopted22/06/2017
Company name

Amgen Europe B.V.

StatusPositive
Application typePost authorisation