Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Filgrastim Hexal   
Auth. number : EU/1/08/496
INN : 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: - 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 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.
- Mobilisation of peripheral blood progenitor cells (PBPC).
- In children and 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.
- Treatment of persistent neutropenia (ANC ≤ 1.0 x 109/l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other therapeutic options are inappropriate.
Marketing Authorisation Holder: Hexal AG
Industriestrasse 25, D-83607 Holzkirchen, Deutschland

  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
10/02/2009 Centralised - Authorisation EMEA/H/C/918 (2009)966 of 06/02/2009
30/09/2009 Centralised - Variation EMEA/H/C/918/II/1
26/10/2009 Centralised - Variation EMEA/H/C/918/II/2 (2009)8320 of 21/10/2009
07/04/2010 Centralised - Variation EMEA/H/C/918/IG/1
Updated with Decision(2010)7734 of 03/11/2010
11/05/2010 Centralised - Variation EMEA/H/C/918/N/3
Updated with Decision(2010)7734 of 03/11/2010
20/09/2010 Centralised - Variation EMEA/H/C/918/IG/18/G
Updated with Decision(2010)7734 of 03/11/2010
24/09/2010 Centralised - Variation EMEA/H/C/918/WS/23
09/11/2010 Centralised - Variation (2010)7734 of 03/11/2010
17/02/2011 Centralised - Variation EMEA/H/C/918/IB/4
Updated with Decision(2011)5953 of 10/08/2011
24/02/2011 Centralised - Variation EMEA/H/C/918/WS/59
25/03/2011 Centralised - Variation EMEA/H/C/918/IG/56/G
12/08/2011 Centralised - Variation EMEA/H/C/918/WS/136/G (2011)5953 of 10/08/2011
10/12/2012 Centralised - Variation EMEA/H/C/918/IB/13
Updated with Decision(2013)8080 of 13/11/2013
15/11/2013 Centralised - Renewal EMEA/H/C/918/R/14 (2013)8080 of 13/11/2013
26/06/2014 Centralised - Variation EMEA/H/C/918/WS/583