Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


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Product information

Invented name: Dynepo
Auth. number : EU/1/02/211
INN : Epoetin delta
ATC: Anatomical main group: B - Blood and blood forming organs
Therapeutic subgroup: B03 - Antianemic preparations
Pharmacological subgroup: B03X - Other antianemic preparations
Chemical subgroup: B03XA - Other antianemic preparations
Chemical substance: B03XA - Other antianemic preparations
(See WHO ATC Index)
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.
Marketing Authorisation Holder: Shire Pharmaceutical Contracts Ltd
Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
21/03/2002 Centralised - Authorisation EMEA/H/C/372 (2002)1232 of 18/03/2002
15/09/2005 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/372/T/1 (2005)3547 of 09/09/2005
16/11/2005 Centralised - Variation EMEA/H/C/372/IA/2
Updated with Decision(2006)2302 of 08/06/2006
12/06/2006 Centralised - Variation EMEA/H/C/372/II/3 (2006)2302 of 08/06/2006
25/09/2006 Centralised - Variation EMEA/H/C/372/II/5
26/10/2006 Centralised - Variation EMEA/H/C/372/II/4, 6, 7 (2006)5156 of 23/10/2006
07/12/2006 Centralised - Variation EMEA/H/C/372/IA/11
Updated with Decision(2007)1591 of 02/04/2007
18/01/2007 Centralised - Variation EMEA/H/C/372/IA/12
20/03/2007 Centralised - Variation EMEA/H/C/372/N/13
Updated with Decision(2008)302 of 18/01/2008
04/04/2007 Centralised - Variation EMEA/H/C/372/II/10 (2007)1591 of 02/04/2007
19/04/2007 Centralised - Renewal EMEA/H/C/372/R/9 (2007)1801 of 17/04/2007
11/06/2007 Centralised - Variation EMEA/H/C/372/IA/17
Updated with Decision(2008)302 of 18/01/2008
24/07/2007 Centralised - Variation EMEA/H/C/372/II/14
22/01/2008 Centralised - Variation (2008)302 of 18/01/2008
29/01/2008 Centralised - Variation EMEA/H/C/372/IB/21, 22
03/03/2008 Centralised - Variation EMEA/H/C/372/II/19
04/03/2008 Centralised - Variation EMEA/H/C/372/II/20 (2008)881 of 29/02/2008
05/05/2008 Centralised - Variation EMEA/H/C/372/II/23
21/07/2008 Centralised - Variation EMEA/H/C/372/IA/24
19/03/2009 Centralised - Withdrawal (2009)2071 of 17/03/2009