Parsabiv

RSS

etelcalcetide

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

Overview

This is a summary of the European public assessment report (EPAR) for Parsabiv. 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 Parsabiv.

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

This EPAR was last updated on 12/10/2018

Authorisation details

Product details
Name
Parsabiv
Agency product number
EMEA/H/C/003995
Active substance
etelcalcetide hydrochloride
International non-proprietary name (INN) or common name
etelcalcetide
Therapeutic area (MeSH)
Hyperparathyroidism, Secondary
Anatomical therapeutic chemical (ATC) code
H05BX04
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Amgen Europe B.V.
Revision
5
Date of issue of marketing authorisation valid throughout the European Union
11/11/2016
Contact address
Minervum 7061
4817 ZK Breda
Netherlands

Product information

05/10/2018 Parsabiv - EMEA/H/C/003995 - IB/0011

Contents

  • 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.

Pharmacotherapeutic group

  • CALCIUM HOMEOSTASIS
  • anti parathyroid agents

Therapeutic indication

Parsabiv is indicated for the treatment of secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) on haemodialysis therapy.

Assessment history

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