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Community Register of medicinal products
Community register of medicinal products for human use |
AUTHORISED |
Product information |
| Invented name: | Nivestim
|
| Auth. number : | EU/1/10/631 |
| INN : | Filgrastim |
| ATC: | L - Antineoplastic and immunomodulating agents L03 - Immunomodulating agents L03A - Immunostimulating agents L03AA - Cytokines 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
Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom |
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 |
| 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 - Variation | 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 | |||
| 14/12/2012 | Centralised - Variation | EMEA/H/C/1142/II/11 | ||||
| 25/04/2013 | Centralised - Variation | EMEA/H/C/1142/II/13/G | ||||