Dynepo

RSS

epoetin delta

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Dynepo has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 23/04/2009

Authorisation details

Product details
Name
Dynepo
Agency product number
EMEA/H/C/000372
Active substance
epoetin delta
International non-proprietary name (INN) or common name
epoetin delta
Therapeutic area (MeSH)
  • Kidney Failure, Chronic
  • Anemia
Anatomical therapeutic chemical (ATC) code
B03XA
Publication details
Marketing-authorisation holder
Shire Pharmaceutical Contracts Limited
Revision
9
Date of issue of marketing authorisation valid throughout the European Union
18/03/2002
Contact address
Shire Pharmaceutical Contracts Ltd.
Hampshire International Business Park
Basingstoke, Hampshire RG24 8EP
United Kingdom

Product information

29/02/2008 Dynepo - EMEA/H/C/000372 - II/0020

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

ANTIANEMIC PREPARATIONS

Therapeutic indication

Dynepo is indicated for the treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult patients. It may be used in patients on dialysis and in patients not on dialysis.

Assessment history

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