Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Aranesp   
Auth. number : EU/1/01/185
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: Amgen Europe B.V.
Minervum 7061, NL-4817 ZK Breda, Nederland

  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/332 (2001)1281 of 08/06/2001
10/10/2001 Centralised - Variation EMEA/H/C/332/I/1 (2001)2785 of 08/10/2001
07/11/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/332/I/2
07/05/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/332/I/5
07/05/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/332/I/6
07/05/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/332/I/4
27/05/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/332/I/11
31/05/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/332/I/7
10/07/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/332/I/10
10/07/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/332/I/9
01/08/2002 Centralised - Variation EMEA/H/C/332/I/8 (2002)3022 of 30/07/2002
26/08/2002 Centralised - Variation EMEA/H/C/332/II/3 (2002)3188 of 22/08/2002
21/03/2003 Centralised - Variation EMEA/H/C/332/II/13 (2003)718 of 27/02/2003
02/04/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/332/I/16
08/04/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/332/I/18
23/04/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/332/I/17
28/07/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/332/II/19
13/08/2003 Centralised - Variation EMEA/H/C/332/II/15 (2003)3037 of 11/08/2003
26/01/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/332/II/21
16/04/2004 Centralised - Variation EMEA/H/C/332/II/22 (2004)1462 of 14/04/2004
04/06/2004 Centralised - Variation EMEA/H/C/332/IA/25
Updated with Decision(2004)3476 of 09/09/2004
13/09/2004 Centralised - Variation EMEA/H/C/332/II/24 (2004)3476 of 09/09/2004
02/03/2005 Centralised - Variation EMEA/H/C/332/II/26 (2005)528 of 28/02/2005
23/03/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/332/II/27
12/07/2005 Centralised - Variation EMEA/H/C/332/II/28 (2005)2730 of 08/07/2005
03/08/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/332/II/29
13/09/2005 Centralised - Variation EMEA/H/C/332/II/30 (2005)3490 of 08/09/2005
28/02/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/332/II/32
02/03/2006 Centralised - Variation EMEA/H/C/332/II/31 (2006)691 of 28/02/2006
23/05/2006 Centralised - Renewal EMEA/H/C/332/R/33 (2006)2121 of 19/05/2006
28/07/2006 Corrigendum EMEA/H/C/332/R/33 (2006)2121 of 25/07/2006
03/08/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/332/II/34
07/08/2006 Centralised - Variation EMEA/H/C/332/IB/36
Updated with Decision(2006)5340 of 30/10/2006
01/11/2006 Centralised - Variation EMEA/H/C/332/II/37 (2006)5340 of 30/10/2006
01/12/2006 Centralised - Variation EMEA/H/C/332/II/38 (2006)5931 of 29/11/2006
26/03/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/332/II/40
04/05/2007 Centralised - Variation EMEA/H/C/332/II/39 (2007)2012 of 02/05/2007
17/08/2007 Centralised - Notification EMEA/H/C/332/N/41
Updated with Decision(2008)813 of 26/02/2008
05/09/2007 Centralised - Variation EMEA/H/C/332/II/35 (2007)4166 of 30/08/2007
28/02/2008 Centralised - Variation EMEA/H/C/332/II/43 (2008)813 of 26/02/2008
07/07/2008 Centralised - Variation EMEA/H/C/332/X/42 (2008)3463 of 03/07/2008
11/08/2008 Centralised - Variation EMEA/H/C/332/IA/47
Updated with Decision(2008)6482 of 28/10/2008
03/09/2008 Centralised - Variation EMEA/H/C/332/II/44 (2008)4823 of 01/09/2008
30/10/2008 Centralised - Variation EMEA/H/C/332/II/48, 46 (2008)6482 of 28/10/2008
01/12/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/332/II/45
21/04/2009 Centralised - Variation EMEA/H/C/332/IA/57
Updated with Decision(2009)8516 of 28/10/2009
21/04/2009 Centralised - Variation EMEA/H/C/332/IA/58
Updated with Decision(2009)8516 of 28/10/2009
21/04/2009 Centralised - Variation EMEA/H/C/332/IA/59
Updated with Decision(2009)8516 of 28/10/2009
21/04/2009 Centralised - Variation EMEA/H/C/332/IA/60
Updated with Decision(2009)8516 of 28/10/2009
21/04/2009 Centralised - Variation EMEA/H/C/332/IA/61
Updated with Decision(2009)8516 of 28/10/2009
21/04/2009 Centralised - Variation EMEA/H/C/332/IA/62
Updated with Decision(2009)8516 of 28/10/2009
21/04/2009 Centralised - Variation EMEA/H/C/332/IA/63
Updated with Decision(2009)8516 of 28/10/2009
21/04/2009 Centralised - Variation EMEA/H/C/332/IA/64
Updated with Decision(2009)8516 of 28/10/2009
21/04/2009 Centralised - Variation EMEA/H/C/332/IA/65
Updated with Decision(2009)8516 of 28/10/2009
21/04/2009 Centralised - Variation EMEA/H/C/332/IA/66
Updated with Decision(2009)8516 of 28/10/2009
21/04/2009 Centralised - Variation EMEA/H/C/332/IA/67
Updated with Decision(2009)8516 of 28/10/2009
21/04/2009 Centralised - Variation EMEA/H/C/332/IA/68
Updated with Decision(2009)8516 of 28/10/2009
21/04/2009 Centralised - Variation EMEA/H/C/332/IA/69
Updated with Decision(2009)8516 of 28/10/2009
21/04/2009 Centralised - Variation EMEA/H/C/332/IA/70
Updated with Decision(2009)8516 of 28/10/2009
21/04/2009 Centralised - Variation EMEA/H/C/332/IA/71
Updated with Decision(2009)8516 of 28/10/2009
21/04/2009 Centralised - Variation EMEA/H/C/332/IA/72
Updated with Decision(2009)8516 of 28/10/2009
21/04/2009 Centralised - Variation EMEA/H/C/332/IA/73
Updated with Decision(2009)8516 of 28/10/2009
21/04/2009 Centralised - Variation EMEA/H/C/332/IA/74
Updated with Decision(2009)8516 of 28/10/2009
21/04/2009 Centralised - Variation EMEA/H/C/332/IA/56
Updated with Decision(2009)8516 of 28/10/2009
21/04/2009 Centralised - Variation EMEA/H/C/332/IA/55
Updated with Decision(2009)8516 of 28/10/2009
21/04/2009 Centralised - Variation EMEA/H/C/332/IA/54
Updated with Decision(2009)8516 of 28/10/2009
21/04/2009 Centralised - Variation EMEA/H/C/332/IA/53
Updated with Decision(2009)8516 of 28/10/2009
21/04/2009 Centralised - Variation EMEA/H/C/332/IA/52
Updated with Decision(2009)8516 of 28/10/2009
21/04/2009 Centralised - Variation EMEA/H/C/332/IA/51
Updated with Decision(2009)8516 of 28/10/2009
21/04/2009 Centralised - Variation EMEA/H/C/332/IA/50
Updated with Decision(2009)8516 of 28/10/2009
21/04/2009 Centralised - Variation EMEA/H/C/332/IA/49
Updated with Decision(2009)8516 of 28/10/2009
30/10/2009 Centralised - Variation EMEA/H/C/332/II/75 (2009)8516 of 28/10/2009
16/11/2009 Centralised - Notification EMEA/H/C/332/N/77
Updated with Decision(2010)1995 of 23/03/2010
25/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/332/II/76
11/02/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/332/II/78
25/03/2010 Centralised - Variation EMEA/H/C/332/II/79 (2010)1995 of 23/03/2010
07/04/2010 Centralised - Variation EMEA/H/C/332/IA/80/G
Updated with Decision(2010)5394 of 28/07/2010
03/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/332/IB/83
02/08/2010 Centralised - Variation EMEA/H/C/332/II/81, 82 (2010)5394 of 28/07/2010
26/08/2010 Centralised - Variation EMEA/H/C/332/IA/85/G
Updated with Decision(2010)8894 of 03/12/2010
07/12/2010 Centralised - Variation (2010)8894 of 03/12/2010
09/12/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/332/IB/89
23/12/2010 Centralised - Variation EMEA/H/C/332/IA/88/G
Updated with Decision(2010)9613 of 20/12/2010
23/12/2010 Centralised - Variation EMEA/H/C/332/II/86, 87 (2010)9613 of 20/12/2010
04/03/2011 Centralised - Variation EMEA/H/C/332/X/84 (2011)1495 of 28/02/2011
15/04/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/332/II/90
07/12/2011 Centralised - Variation EMEA/H/C/332/II/92/G (2011)9172 of 05/12/2011
05/01/2012 Centralised - Notification EMEA/H/C/332/N/97
Updated with Decision(2012)7895 of 29/10/2012
13/08/2012 Centralised - Notification EMEA/H/C/332/N/103
Updated with Decision(2012)7895 of 29/10/2012
16/08/2012 Centralised - Variation EMEA/H/C/332/IA/106
Updated with Decision(2012)7895 of 29/10/2012
01/11/2012 Centralised - Variation (2012)7895 of 29/10/2012
29/07/2013 Centralised - 2-Monthly update EMEA/H/C/332/II/108 (2013)4944 of 25/07/2013
12/09/2013 Centralised - Variation EMEA/H/C/332/IB/114
Updated with Decision(2014)6738 of 16/09/2014
06/06/2014 Centralised - Notification EMEA/H/C/332/N/124
Updated with Decision(2014)6738 of 16/09/2014
19/09/2014 Centralised - Yearly update (2014)6738 of 16/09/2014
12/11/2014 Centralised - Variation EMEA/H/C/332/IB/131/G