Dynepo

RSS
Withdrawn

This medicine's authorisation has been withdrawn

epoetin delta
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

On 18 March 2002 the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Dynepo (epoetin delta), which had been approved for the treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult patients. The marketing authorisation holder (MAH) responsible for Dynepo was Shire Pharmaceutical Contract Limited. 

The European Commission was notified by letter dated 17 February 2009 of the MAH’s decision to voluntarily withdraw the marketing authorisation for Dynepo for commercial reasons. On 17 March 2009 the European Commission issued a decision to withdraw the marketing authorisation for Dynepo. 

Pursuant to this decision the European Public Assessment Report for Dynepo is updated to reflect that the marketing authorisation is no longer valid

български (BG) (444.96 KB - PDF)

View

español (ES) (257.67 KB - PDF)

View

čeština (CS) (420.32 KB - PDF)

View

dansk (DA) (257.27 KB - PDF)

View

Deutsch (DE) (258.33 KB - PDF)

View

eesti keel (ET) (256.47 KB - PDF)

View

ελληνικά (EL) (438.27 KB - PDF)

View

français (FR) (258.55 KB - PDF)

View

italiano (IT) (257.39 KB - PDF)

View

latviešu valoda (LV) (423.89 KB - PDF)

View

lietuvių kalba (LT) (395.92 KB - PDF)

View

magyar (HU) (411.43 KB - PDF)

View

Malti (MT) (427.18 KB - PDF)

View

Nederlands (NL) (257.57 KB - PDF)

View

polski (PL) (428.88 KB - PDF)

View

português (PT) (257.8 KB - PDF)

View

română (RO) (390.57 KB - PDF)

View

slovenčina (SK) (416.18 KB - PDF)

View

slovenščina (SL) (408.4 KB - PDF)

View

Suomi (FI) (256.75 KB - PDF)

View

svenska (SV) (257.24 KB - PDF)

View

Product information

български (BG) (1.44 MB - PDF)

View

español (ES) (1.22 MB - PDF)

View

čeština (CS) (1.35 MB - PDF)

View

dansk (DA) (1.05 MB - PDF)

View

Deutsch (DE) (966.03 KB - PDF)

View

eesti keel (ET) (1.15 MB - PDF)

View

ελληνικά (EL) (1.7 MB - PDF)

View

français (FR) (1.02 MB - PDF)

View

italiano (IT) (1.06 MB - PDF)

View

latviešu valoda (LV) (1.39 MB - PDF)

View

lietuvių kalba (LT) (1.13 MB - PDF)

View

magyar (HU) (1.19 MB - PDF)

View

Malti (MT) (1.46 MB - PDF)

View

Nederlands (NL) (1.16 MB - PDF)

View

polski (PL) (1.28 MB - PDF)

View

português (PT) (1.07 MB - PDF)

View

română (RO) (1.09 MB - PDF)

View

slovenčina (SK) (1.07 MB - PDF)

View

slovenščina (SL) (1.02 MB - PDF)

View

Suomi (FI) (881.44 KB - PDF)

View

svenska (SV) (927.68 KB - PDF)

View
Latest procedure affecting product information: II/0020
29/02/2008
icon globe

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

 

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).

български (BG) (325 KB - PDF)

View

español (ES) (230.66 KB - PDF)

View

čeština (CS) (323.33 KB - PDF)

View

dansk (DA) (230.71 KB - PDF)

View

Deutsch (DE) (230.61 KB - PDF)

View

eesti keel (ET) (230.86 KB - PDF)

View

ελληνικά (EL) (324.01 KB - PDF)

View

français (FR) (230.94 KB - PDF)

View

italiano (IT) (225.55 KB - PDF)

View

latviešu valoda (LV) (320.21 KB - PDF)

View

lietuvių kalba (LT) (295.34 KB - PDF)

View

magyar (HU) (317.21 KB - PDF)

View

Malti (MT) (336.87 KB - PDF)

View

Nederlands (NL) (225.28 KB - PDF)

View

polski (PL) (320.8 KB - PDF)

View

português (PT) (225.79 KB - PDF)

View

română (RO) (292.94 KB - PDF)

View

slovenčina (SK) (317.13 KB - PDF)

View

slovenščina (SL) (247.56 KB - PDF)

View

Suomi (FI) (230.58 KB - PDF)

View

svenska (SV) (225.96 KB - PDF)

View

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
Withdrawal of marketing authorisation
17/03/2009
Revision
9

Assessment history

This page was last updated on

Share this page