Aranesp

RSS

darbepoetin alfa

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

Overview

This is a summary of the European public assessment report (EPAR) for Aranesp. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Aranesp.

This EPAR was last updated on 10/07/2018

Authorisation details

Product details
Name
Aranesp
Agency product number
EMEA/H/C/000332
Active substance
darbepoetin alfa
International non-proprietary name (INN) or common name
darbepoetin alfa
Therapeutic area (MeSH)
  • Anemia
  • Cancer
  • Kidney Failure, Chronic
Anatomical therapeutic chemical (ATC) code
B03XA02
Publication details
Marketing-authorisation holder
Amgen Europe B.V.
Revision
40
Date of issue of marketing authorisation valid throughout the European Union
08/06/2001
Contact address
Minervum 7061
NL-4817 ZK Breda
The Netherlands

Product information

20/06/2018 Aranesp - EMEA/H/C/000332 - N/0087

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

Anti anaemic preparations

Therapeutic indication

Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adults and paediatric patients.

Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.

Assessment history

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