Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Nivestim   
Auth. number : EU/1/10/631
Active substance : Filgrastim
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: L03AA02 - Filgrastim
(See WHO ATC Index)
Indication: Filgrastim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy.Filgrastim is indicated for the mobilisation of peripheral blood progenitor cells (PBPC).In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of 0.5 x 109 /l and a history of severe or recurrent infections, long term administration of filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.Filgrastim is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109 /l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.
Marketing Authorisation Holder: Hospira UK Limited
Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom
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
10/06/2010 Centralised - Authorisation EMEA/H/C/1142 (2010)3808 of 08/06/2010
27/07/2010 Centralised - Variation EMEA/H/C/1142/IA/1
Updated with Decision(2011)697 of 01/02/2011
28/10/2010 Centralised - Variation EMEA/H/C/1142/IB/2
Updated with Decision(2011)697 of 01/02/2011
30/11/2010 Centralised - Variation EMEA/H/C/1142/IB/3
Updated with Decision(2011)697 of 01/02/2011
03/02/2011 Centralised - Variation (2011)697 of 01/02/2011
27/07/2011 Centralised - Notification EMEA/H/C/1142/N/4
Updated with Decision(2012)4177 of 14/06/2012
19/12/2011 Centralised - Variation EMEA/H/C/1142/IA/5/G
Updated with Decision(2012)4177 of 14/06/2012
18/06/2012 Centralised - Variation (2012)4177 of 14/06/2012
13/12/2012 Centralised - Variation EMEA/H/C/1142/II/11
Updated with Decision(2013)9723 of 18/12/2013
25/04/2013 Centralised - Variation EMEA/H/C/1142/II/13/G
Updated with Decision(2013)9723 of 18/12/2013
07/08/2013 Centralised - Notification EMEA/H/C/1142/N/17
Updated with Decision(2013)9723 of 18/12/2013
20/12/2013 Centralised - Yearly update (2013)9723 of 18/12/2013
21/01/2014 Centralised - Variation EMEA/H/C/1142/IB/19
Updated with Decision(2015)211 of 15/01/2015
01/08/2014 Centralised - Variation EMEA/H/C/1142/IA/23/G
Updated with Decision(2015)211 of 15/01/2015
05/01/2015 Centralised - Notification EMEA/H/C/1142/N/27
Updated with Decision(2015)3636 of 27/05/2015
19/01/2015 Centralised - Yearly update (2015)211 of 15/01/2015
29/05/2015 Centralised - Renewal EMEA/H/C/1142/R/25 (2015)3636 of 27/05/2015
16/07/2015 Centralised - Variation EMEA/H/C/1142/IAin/32
14/08/2015 Centralised - Variation EMEA/H/C/1142/IAIN/35/G
14/08/2015 Centralised - Variation EMEA/H/C/1142/IAIN/34
17/06/2016 Centralised - Notification EMEA/H/C/1142/N/42