Dynepo
epoetin delta
Table of contents
Withdrawn
This medicine is now withdrawn from use in the European Union.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The marketing authorisation for Dynepo has been withdrawn at the request of the marketing authorisation holder.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) |
|
| 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
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Pharmacotherapeutic group
Antianemic preparations
Therapeutic indication
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.