Cinacalcet Mylan

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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 Cinacalcet Mylan. 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 Cinacalcet Mylan.

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

This EPAR was last updated on 12/09/2022

Authorisation details

Product details
Name
Cinacalcet Mylan
Agency product number
EMEA/H/C/004014
Active substance
cinacalcet hydrochloride
International non-proprietary name (INN) or common name
cinacalcet
Therapeutic area (MeSH)
  • Hyperparathyroidism, Secondary
  • Hypercalcemia
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
Mylan Pharmaceuticals Limited
Revision
14
Date of issue of marketing authorisation valid throughout the European Union
19/11/2015
Contact address

Mylan Pharmaceuticals Limited
Damastown Industrial Park
Mulhuddart
Dublin 15
Ireland

Product information

12/09/2022 Cinacalcet Mylan - EMEA/H/C/004014 - N/0021

Other EU languages available icon 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:

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.

Pharmacotherapeutic group

Calcium homeostasis

Therapeutic indication

Treatment of secondary hyperparathyroidism (HPT) in patients with end-stage renal disease (ESRD) on maintenance dialysis therapy.

Cinacalcet Mylan may be used as part of a therapeutic regimen including phosphate binders and/or vitamin D sterols, as appropriate.

Reduction of hypercalcaemia in 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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