Dynepo

Withdrawn

This medicine's authorisation has been withdrawn

epoetin delta

Overview

The marketing authorisation for Dynepo has been withdrawn at the request of the marketing authorisation holder.

Dynepo : EPAR - Summary for the public

Product information

Dynepo : EPAR - Product Information

Latest procedure affecting product information: II/0020

29/02/2008

This medicine’s product information is available in all official EU languages.
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Product information documents contain:

• summary of product characteristics (annex I);
• manufacturing authorisation holder responsible for batch release (annex IIA);
• conditions of the marketing authorisation (annex IIB);
• labelling (annex IIIA);
• package leaflet (annex IIIB).

Dynepo : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Dynepo
• 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

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.

Authorisation details

• EMA product number:
  EMEA/H/C/000372
• Marketing authorisation holder:
  Shire Pharmaceutical Contracts Limited

  Shire Pharmaceutical Contracts Ltd.; Hampshire International Business Park; Basingstoke, Hampshire RG24 8EP; United Kingdom

• Marketing authorisation issued:
  18/03/2002
• Revision:
  9

Assessment history

Changes since initial authorisation of medicine

Dynepo : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Dynepo : EPAR - Procedural steps taken before authorisation

Dynepo : EPAR - Scientific Discussion