Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


WITHDRAWN  

Product information

Invented name: Neupopeg
Auth. number : EU/1/02/228
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: 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
26/08/2002 Centralised - Authorisation EMEA/H/C/422 (2002)3185 of 22/08/2002
27/01/2003 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/422/T/1 (2003)398 of 23/01/2003
02/06/2003 Centralised - Variation EMEA/H/C/422/II/2
15/01/2004 Centralised - Variation EMEA/H/C/422/II/4
03/02/2004 Centralised - Variation EMEA/H/C/422/II/3 (2004)294 of 29/01/2004
27/04/2004 Centralised - Variation EMEA/H/C/422/II/5
27/04/2004 Centralised - Variation EMEA/H/C/422/II/9
21/06/2004 Centralised - Variation EMEA/H/C/422/IA/12
Updated with Decision(2005)200 of 25/01/2005
29/06/2004 Centralised - Variation EMEA/H/C/422/II/10
06/07/2004 Centralised - Variation EMEA/H/C/422/IB/11
Updated with Decision(2005)200 of 25/01/2005
02/08/2004 Centralised - Variation EMEA/H/C/422/II/8
09/08/2004 Centralised - Variation EMEA/H/C/422/IB/15
27/01/2005 Centralised - Variation EMEA/H/C/422/II/14 (2005)200 of 25/01/2005
21/03/2005 Centralised - Variation EMEA/H/C/422/II/15
21/03/2005 Centralised - Variation EMEA/H/C/422/II/17
29/04/2005 Centralised - Variation EMEA/H/C/422/II/18 (2005)1391 of 27/04/2005
01/07/2005 Centralised - Variation EMEA/H/C/422/IA/22
03/08/2005 Centralised - Variation EMEA/H/C/422/II/20 (2005)3054 of 01/08/2005
02/09/2005 Centralised - Variation EMEA/H/C/422/II/20 (2005)3399 of 31/08/2005
04/11/2005 Centralised - Variation EMEA/H/C/422/II/16, 21 (2005)4348 of 28/10/2005
13/01/2006 Centralised - Variation EMEA/H/C/422/IB/23
20/01/2006 Centralised - Variation EMEA/H/C/422/IA/25
20/01/2006 Centralised - Variation EMEA/H/C/422/II/24
03/05/2006 Centralised - Variation EMEA/H/C/422/II/24
09/01/2007 Centralised - Variation EMEA/H/C/422/II/27 (2007)12 of 03/01/2007
27/03/2007 Centralised - Variation EMEA/H/C/422/II/30
27/03/2007 Centralised - Variation EMEA/H/C/422/II/29
18/07/2007 Centralised - Renewal EMEA/H/C/422/R/31 (2007)3509 of 16/07/2007
08/10/2007 Corrigendum EMEA/H/C/422/R/31 (2007)3509 corr of 04/10/2007
21/11/2007 Centralised - Variation EMEA/H/C/422/II/34
22/11/2007 Centralised - Variation EMEA/H/C/422/II/32, 33 (2007)5705 of 20/11/2007
21/01/2008 Centralised - Variation EMEA/H/C/422/II/35 (2008)289 of 17/01/2008
26/02/2008 Centralised - Variation EMEA/H/C/422/II/36
23/04/2008 Centralised - Variation EMEA/H/C/422/II/37 (2008)1634 of 18/04/2008
05/06/2008 Centralised - Variation EMEA/H/C/422/II/38
09/12/2008 Centralised - Withdrawal (2008)8251 of 05/12/2008