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Community Register of medicinal products
Community register of medicinal products for human use |
AUTHORISED |
Product information |
| Invented name: | Neulasta
|
| Auth. number : | EU/1/02/227 |
| INN : | Pegfilgrastim |
| ATC: | L - Antineoplastic and immunomodulating agents L03 - Immunomodulating agents L03A - Immunostimulating agents L03AA - Cytokines 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
|
The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
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 continues to be available in the Community Register. |
European Commission procedures
| 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 | EMEA/H/C/420/II/1 | ||||
| 15/01/2004 | Centralised - Variation | 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 | 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 | EMEA/H/C/420/II/8 | ||||
| 29/06/2004 | Centralised - Variation | 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 | EMEA/H/C/420/II/7 | ||||
| 09/08/2004 | Centralised - Variation | 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 | EMEA/H/C/420/II/16 | ||||
| 21/03/2005 | Centralised - Variation | EMEA/H/C/420/II/14 | ||||
| 03/05/2005 | Centralised - Variation | EMEA/H/C/420/II/17 | (2005)1419 of 29/04/2005 | |||
| 01/07/2005 | Centralised - Variation | 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 | EMEA/H/C/420/IB/22 | ||||
| 19/01/2006 | Centralised - Variation | EMEA/H/C/420/IA/25 | ||||
| 20/01/2006 | Centralised - Variation | EMEA/H/C/420/IA/24 | ||||
| 03/05/2006 | Centralised - Variation | 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 | EMEA/H/C/420/II/28 | ||||
| 27/03/2007 | Centralised - Variation | 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 | 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 | 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 | EMEA/H/C/420/II/36 | ||||
| 15/08/2008 | Centralised - Variation | 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 - Variation | EMEA/H/C/420/N/42 | ||||
| Updated with Decision(2011)2623 of 08/04/2011 | ||||||
| 02/02/2010 | Centralised - Variation | EMEA/H/C/420/II/41 | ||||
| 10/05/2010 | Centralised - Variation | 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 | EMEA/H/C/420/WS/43/G | ||||
| 16/12/2010 | Centralised - Variation | 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 - Variation | 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 - Variation | EMEA/H/C/420/N/53 | ||||
| 29/11/2012 | Centralised - Variation | EMEA/H/C/420/IA/61/G | ||||