Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


WITHDRAWN  

Product information

Invented name: Nespo
Auth. number : EU/1/01/184
INN : darbepoetin alfa
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: B03XA02 - Darbepoetin alfa
(See WHO ATC Index)
Indication: Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adults and paediatric patients.
Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.
Marketing Authorisation Holder: Dompé Biotec S.p.A.
Via San Martino, 12, I-20122 Milano, Italia

  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
11/06/2001 Centralised - Authorisation EMEA/H/C/333 (2001)1280 of 08/06/2001
04/10/2001 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/333/T/7 (2001)2760 of 01/10/2001
17/10/2001 Centralised - Variation EMEA/H/C/333/I/1 (2001)2846 of 16/10/2001
07/11/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/333/I/2
07/05/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/333/I/6
07/05/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/333/I/7
07/05/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/333/I/5
08/07/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/333/I/10
08/07/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/333/I/11
01/08/2002 Centralised - Variation EMEA/H/C/333/I/9 (2002)3019 of 30/07/2002
26/08/2002 Centralised - Variation EMEA/H/C/333/I/1 (2002)3187 of 22/08/2002
15/10/2002 Centralised - Variation EMEA/H/C/333/I/13 (2002)3962 of 11/10/2002
24/03/2003 Centralised - Variation EMEA/H/C/333/II/15 (2003)719 of 27/02/2003
02/04/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/333/I/17
08/04/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/333/I/19
24/04/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/333/I/18
28/07/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/333/II/20
13/08/2003 Centralised - Variation EMEA/H/C/333/II/16 (2003)3034 of 11/08/2003
26/01/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/333/II/22
16/04/2004 Centralised - Variation EMEA/H/C/333/II/23 (2004)1477 of 14/04/2004
04/06/2004 Centralised - Variation EMEA/H/C/333/IA/26
Updated with Decision(2004)3482 of 09/09/2004
13/09/2004 Centralised - Variation EMEA/H/C/333/II/25 (2004)3482 of 09/09/2004
03/02/2005 Centralised - Variation EMEA/H/C/333/II/27 (2005)527 of 28/02/2005
23/03/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/333/II/285
12/07/2005 Centralised - Variation EMEA/H/C/333/II/29 (2005)2732 of 08/07/2005
13/09/2005 Centralised - Variation EMEA/H/C/333/II/31 (2005)3485 of 08/09/2005
28/02/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/333/II/33
02/03/2006 Centralised - Variation EMEA/H/C/333/II/32 (2006)700 of 28/02/2006
23/05/2006 Centralised - Renewal EMEA/H/C/333/R/34 (2006)2120 of 19/05/2006
03/08/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/333/II/35
07/08/2006 Centralised - Variation EMEA/H/C/333/IB/37
Updated with Decision(2006)5338 of 30/10/2006
02/11/2006 Centralised - Variation EMEA/H/C/333/II/38 (2006)5338 of 30/10/2006
01/12/2006 Centralised - Variation EMEA/H/C/333/II/39 (2006)5921 of 28/11/2006
09/03/2007 Corrigendum EMEA/H/C/333/II/38 (2006)5338 corr of 07/03/2007
25/03/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/333/II/41
04/05/2007 Centralised - Variation EMEA/H/C/333/II/40 (2007)2011 of 02/05/2007
17/08/2007 Centralised - Notification EMEA/H/C/333/N/42
Updated with Decision(2008)816 of 26/02/2008
05/09/2007 Centralised - Variation EMEA/H/C/333/II/36 (2007)4171 of 30/08/2007
28/02/2008 Centralised - Variation EMEA/H/C/333/II/44 (2008)816 of 26/02/2008
07/07/2008 Centralised - Variation EMEA/H/C/333/X/43 (2008)3460 of 03/07/2008
02/09/2008 Centralised - Variation EMEA/H/C/333/II/45 (2008)4782 of 29/08/2008
30/10/2008 Centralised - Variation EMEA/H/C/333/II/46, 47 (2008)6485 of 28/10/2008
09/12/2008 Centralised - Withdrawal (2008)8250 of 05/12/2008