Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Neulasta   
Auth. number : EU/1/02/227
INN : Pegfilgrastim
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L03 - Immunomodulating agents
Pharmacological subgroup: L03A - Immunostimulating agents
Chemical subgroup: L03AA - Cytokines
Chemical substance: L03AA13 - Pegfilgrastim
(See WHO ATC Index)
Indication: Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
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
26/08/2002 Centralised - Authorisation EMEA/H/C/420 (2002)3186 of 22/08/2002
02/06/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/420/II/1
15/01/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/420/II/3
03/02/2004 Centralised - Variation EMEA/H/C/420/II/2 (2004)293 of 29/01/2004
27/04/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/420/II/4
21/06/2004 Centralised - Variation EMEA/H/C/420/IA/11
Updated with Decision(2005)201 of 25/01/2005
27/06/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/420/II/8
29/06/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/420/II/9
06/07/2004 Centralised - Variation EMEA/H/C/420/IB/10
Updated with Decision(2005)201 of 25/01/2005
02/08/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/420/II/7
09/08/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/420/IB/12
27/01/2005 Centralised - Variation EMEA/H/C/420/II/13 (2005)201 of 25/01/2005
21/03/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/420/II/14
21/03/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/420/II/16
03/05/2005 Centralised - Variation EMEA/H/C/420/II/17 (2005)1419 of 29/04/2005
01/07/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/420/IA/21
03/08/2005 Centralised - Variation EMEA/H/C/420/II/19 (2005)3050 of 01/08/2005
02/09/2005 Centralised - Variation EMEA/H/C/420/II/18 (2005)3393 of 31/08/2005
04/11/2005 Centralised - Variation EMEA/H/C/420/II/15, 20 (2005)4350 of 28/10/2005
13/01/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/420/IB/22
19/01/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/420/IA/25
20/01/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/420/IA/24
03/05/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/420/II/23
09/01/2007 Centralised - Variation EMEA/H/C/420/II/26 (2007)13 of 03/01/2007
27/03/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/420/II/28
27/03/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/420/II/29
18/07/2007 Centralised - Renewal EMEA/H/C/420/R/30 (2007)3506 of 16/07/2007
08/10/2007 Corrigendum EMEA/H/C/420/R/30 (2007)3506 corr of 04/10/2007
21/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/420/II/33
22/11/2007 Centralised - Variation EMEA/H/C/420/II/31, 32 (2007)5701 of 20/11/2007
21/01/2008 Centralised - Variation EMEA/H/C/420/II/34 (2008)290 of 17/01/2008
26/02/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/420/II/35
23/04/2008 Centralised - Variation EMEA/H/C/420/II/37 (2008)1652 of 21/04/2008
05/06/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/420/II/36
15/08/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/420/IB/38
21/04/2009 Centralised - Variation EMEA/H/C/420/IA/39
Updated with Decision(2009)8391 of 23/10/2009
27/10/2009 Centralised - Variation EMEA/H/C/420/II/40 (2009)8391 of 23/10/2009
26/01/2010 Centralised - Notification EMEA/H/C/420/N/42
Updated with Decision(2011)2623 of 08/04/2011
02/02/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/420/II/41
10/05/2010 Centralised - Notification EMEA/H/C/420/N/43
Updated with Decision(2011)2623 of 08/04/2011
27/09/2010 Centralised - Variation EMEA/H/C/420/IB/44
Updated with Decision(2011)2623 of 08/04/2011
16/12/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/420/WS/43/G
16/12/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/420/IB/45/G
12/04/2011 Centralised - Variation (2011)2623 of 08/04/2011
01/06/2011 Centralised - Variation EMEA/H/C/420/II/46 (2011)3870 of 27/05/2011
24/10/2011 Centralised - Variation EMEA/H/C/420/IB/48
Updated with Decision(2012)3638 of 25/05/2012
17/01/2012 Centralised - Notification EMEA/H/C/420/N/50
Updated with Decision(2012)3638 of 25/05/2012
01/06/2012 Centralised - Variation (2012)3638 of 25/05/2012
26/06/2012 Centralised - Notification EMEA/H/C/420/N/53
Updated with Decision(2013)5752 of 03/09/2013
29/11/2012 Centralised - Variation EMEA/H/C/420/IAIN/61/G
Updated with Decision(2013)5752 of 03/09/2013
15/07/2013 Centralised - Notification EMEA/H/C/420/N/68
Updated with Decision(2013)5752 of 03/09/2013
02/08/2013 Centralised - Variation EMEA/H/C/420/IB/67
Updated with Decision(2013)816 of 15/11/2013
05/09/2013 Centralised - 2-Monthly update EMEA/H/C/420/WS/399 (2013)5752 of 03/09/2013
19/11/2013 Centralised - Modification EMEA/H/C/420/PSUV/71, PSUR/53 (2013)816 of 15/11/2013
21/11/2013 Centralised - Variation EMEA/H/C/420/II/70
09/04/2014 Corrigendum (2013)816 of 15/11/2013
22/05/2014 Centralised - Variation EMEA/H/C/420/II/75
27/06/2014 Centralised - Notification EMEA/H/C/420/N/79
15/08/2014 Centralised - Variation EMEA/H/C/420/IB/80