Aranesp
darbepoetin alfa
Table of contents
Overview
Aranesp is a medicine used to treat anaemia (low red blood cell counts) that is causing symptoms. It is used in two groups of patients:
- adults and children with chronic renal failure (long-term, decreasing in the ability of the kidneys to work properly);
- adults who are receiving chemotherapy for non‑myeloid cancer (cancer not originating in the bone marrow).
Aranesp contains the active substance darbepoetin alfa.
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List item
Aranesp : EPAR - Medicine overview (PDF/80.72 KB)
First published: 07/11/2007
Last updated: 14/05/2019 -
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List item
Aranesp : EPAR - Risk-management-plan summary (PDF/50.68 KB)
First published: 14/05/2019
Last updated: 13/01/2020
This EPAR was last updated on 13/01/2020
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) |
|
Anatomical therapeutic chemical (ATC) code |
B03XA02
|
Publication details | |
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Marketing-authorisation holder |
Amgen Europe B.V.
|
Revision |
42
|
Date of issue of marketing authorisation valid throughout the European Union |
08/06/2001
|
Contact address |
Product information
14/11/2019 Aranesp - EMEA/H/C/000332 - II/0150
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
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Pharmacotherapeutic group
Pharmacotherapeutic group
Other antianemic preparations
Therapeutic indication
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.