Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Biograstim   
Auth. number : EU/1/08/450
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. Mobilisation of peripheral blood progenitor cells (PBPC). Severe congenital, cyclic, or idiopathic neutropenia, persistent neutropenia.
Marketing Authorisation Holder: AbZ-Pharma 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/826 (2008)5216 of 15/09/2008
11/11/2009 Centralised - Variation EMEA/H/C/826/IA/2
Updated with Decision(2009)10780 of 23/12/2009
11/11/2009 Centralised - Variation EMEA/H/C/826/IA/3
Updated with Decision(2009)10780 of 23/12/2009
29/12/2009 Centralised - Variation EMEA/H/C/826/II/1 (2009)10780 of 23/12/2009
10/03/2010 Centralised - Variation EMEA/H/C/826/IA/4
Updated with Decision(2010)7218 of 14/10/2010
26/05/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/826/IB/7
26/05/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/826/IB/6
07/07/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/826/II/5
03/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/826/IB/8
18/10/2010 Centralised - Variation (2010)7218 of 14/10/2010
21/02/2011 Centralised - Variation EMEA/H/C/826/IB/9/G
Updated with Decision(2011)5847 of 05/08/2011
10/08/2011 Centralised - Variation EMEA/H/C/826/II/10 (2011)5847 of 05/08/2011
07/03/2012 Centralised - Variation EMEA/H/C/826/IAin/16
Updated with Decision(2012)7155 of 08/10/2012
11/10/2012 Centralised - Variation (2012)7155 of 08/10/2012
25/10/2012 Centralised - Variation EMEA/H/C/826/IB/23
Updated with Decision(2012)7883 of 29/10/2012
05/11/2012 Centralised - Variation (2012)7883 of 29/10/2012
29/07/2013 Centralised - Renewal EMEA/H/C/826/R/25 (2013)4946 of 25/07/2013
11/10/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/826/T/28 (2013)6807 of 09/10/2013
30/10/2013 Centralised - Variation EMEA/H/C/826/IB/29
Updated with Decision(2014)8408 of 07/11/2014
11/11/2014 Centralised - Yearly update (2014)8408 of 07/11/2014