Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Zarzio   
Auth. number : EU/1/08/495
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: Sandoz GmbH
Biochemiestrasse 10, A-6250 Kundl, Österreich

  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/917 (2009)974 of 06/02/2009
30/09/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/917/II/1
23/10/2009 Centralised - Variation EMEA/H/C/917/II/2 (2009)8319 of 21/10/2009
07/04/2010 Centralised - Variation EMEA/H/C/917/IG/1
Updated with Decision(2010)7731 of 03/11/2010
11/05/2010 Centralised - Notification EMEA/H/C/917/N/3
Updated with Decision(2010)7731 of 03/11/2010
20/09/2010 Centralised - Variation EMEA/H/C/917/IG/18/G
Updated with Decision(2010)7731 of 03/11/2010
24/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/917/WS/23
09/11/2010 Centralised - Variation (2010)7731 of 03/11/2010
17/02/2011 Centralised - Variation EMEA/H/C/917/IB/4
Updated with Decision(2011)5952 of 10/08/2011
24/02/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/917/WS/59
25/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/917/IG/56/G
12/08/2011 Centralised - Variation EMEA/H/C/917/WS/136/G (2011)5952 of 10/08/2011
17/10/2011 Centralised - Notification EMEA/H/C/917/N/5
Updated with Decision(2013)8079 of 13/11/2013
10/12/2012 Centralised - Variation EMEA/H/C/917/IB/14
Updated with Decision(2013)8079 of 13/11/2013
15/11/2013 Centralised - Renewal EMEA/H/C/917/R/15 (2013)8079 of 13/11/2013
15/11/2013 Centralised - Variation EMEA/H/C/917/IB/17
26/06/2014 Centralised - Variation EMEA/H/C/917/WS/583
29/10/2014 Corrigendum (2014)8181 of 27/10/2014