Cinacalcet Accordpharma

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cinacalcet

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

Overview

Cinacalcet Accordpharma is a medicine used to treat:

  • secondary hyperparathyroidism (overactive parathyroid glands) in adults and children aged 3 years and older with serious kidney disease who need dialysis (to clear their blood of waste products);
  • hypercalcaemia (high blood calcium levels) in adults with cancer of the parathyroid glands or with primary hyperparathyroidism when the parathyroid glands cannot be removed.

In hyperparathyroidism, the parathyroid glands in the neck produce too much parathyroid hormone (PTH), which can lead to high levels of blood calcium, bone and joint pain and deformities of the arms and legs. ‘Secondary’ means that it is caused by another condition (serious kidney disease) while ‘primary’ means there is no other cause.

Cinacalcet Accordpharma contains the active substance cinacalcet and is a ‘generic medicine’. This means that Cinacalcet Accordpharma contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Mimpara.

This EPAR was last updated on 04/09/2020

Authorisation details

Product details
Name
Cinacalcet Accordpharma
Agency product number
EMEA/H/C/005236
Active substance
cinacalcet (as hydrochloride)
International non-proprietary name (INN) or common name
cinacalcet
Therapeutic area (MeSH)
Hyperparathyroidism
Anatomical therapeutic chemical (ATC) code
H05BX01
GenericGeneric

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder
Accord Healthcare S.L.U.
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
03/04/2020
Contact address

World Trade Center
Moll de Barcelona
s/n, Edifici Est 6ª planta
08039 Barcelona
Spain

Product information

18/08/2020 Cinacalcet Accordpharma - EMEA/H/C/005236 - IAIN/0001/G

Contents

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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 (see section 4.4).

Cinacalcet Accordpharma 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.

Assessment history

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