Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Ratiograstim   
Auth. number : EU/1/08/444
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: Ratiograstim 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.
Ratiograstim 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 Ratiograstim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.
Ratiograstim 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: ratiopharm GmbH
Graf-Arco-Straße 3, D-89079 Ulm, 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
17/09/2008 Centralised - Authorisation EMEA/H/C/825rev (2008)5214 of 15/09/2008
11/11/2009 Centralised - Variation EMEA/H/C/825/IA/2
Updated with Decision(2010)77 of 08/01/2010
11/11/2009 Centralised - Variation EMEA/H/C/825/IA/3
Updated with Decision(2010)77 of 08/01/2010
11/11/2009 Centralised - Variation EMEA/H/C/825/IA/4
Updated with Decision(2010)77 of 08/01/2010
11/11/2009 Centralised - Variation EMEA/H/C/825/IA/5
Updated with Decision(2010)77 of 08/01/2010
13/01/2010 Centralised - Variation EMEA/H/C/825/II/1 (2010)77 of 08/01/2010
24/03/2010 Centralised - Variation EMEA/H/C/825/IA/6
Updated with Decision(2010)7208 of 14/10/2010
25/05/2010 Centralised - Variation EMEA/H/C/825/IB/9
25/05/2010 Centralised - Variation EMEA/H/C/825/IB/8
05/07/2010 Centralised - Variation EMEA/H/C/825/II/7
14/10/2010 Centralised - Variation EMEA/H/C/825/IB/10
14/10/2010 Centralised - Variation EMEA/H/C/825/IA/11
18/10/2010 Centralised - Variation (2010)7208 of 14/10/2010
28/02/2011 Centralised - Variation EMEA/H/C/825/IB/12/G
Updated with Decision(2011)5383 of 20/07/2011
25/07/2011 Centralised - Variation EMEA/H/C/825/II/13 (2011)5383 of 20/07/2011
26/10/2012 Centralised - Variation EMEA/H/C/825/IB/25
Updated with Decision(2012)8004 of 31/10/2012
07/11/2012 Centralised - Variation (2012)8004 of 31/10/2012
23/07/2013 Centralised - Renewal EMEA/H/C/825/R/27 (2013)4805 of 19/07/2013
04/12/2013 Centralised - Variation EMEA/H/C/825/IB/30