Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Tevagrastim   
Auth. number : EU/1/08/445
Active substance : 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: Tevagrastim 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.

Tevagrastim 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 Tevagrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.

Tevagrastim 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: Teva 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/827 (2008)5213 of 15/09/2008
23/02/2009 Centralised - Notification EMEA/H/C/827/N/1
Updated with Decision(2009)10699 of 21/12/2009
09/09/2009 Centralised - Variation EMEA/H/C/827/IA/2
Updated with Decision(2009)10699 of 21/12/2009
05/10/2009 Centralised - Variation EMEA/H/C/827/IA/9
Updated with Decision(2009)10699 of 21/12/2009
05/10/2009 Centralised - Variation EMEA/H/C/827/IA/10
Updated with Decision(2009)10699 of 21/12/2009
05/10/2009 Centralised - Variation EMEA/H/C/827/IA/8
Updated with Decision(2009)10699 of 21/12/2009
05/10/2009 Centralised - Variation EMEA/H/C/827/IA/6
Updated with Decision(2009)10699 of 21/12/2009
05/10/2009 Centralised - Variation EMEA/H/C/827/IA/5
Updated with Decision(2009)10699 of 21/12/2009
05/10/2009 Centralised - Variation EMEA/H/C/827/IA/7
Updated with Decision(2009)10699 of 21/12/2009
23/12/2009 Centralised - Variation EMEA/H/C/827/II/4 (2009)10699 of 21/12/2009
25/05/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/827/IB/13
25/05/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/827/IB/12
05/07/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/827/II/11
14/10/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/827/IA/16
14/10/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/827/IB/14
14/10/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/827/IA/15
12/11/2010 Centralised - Variation EMEA/H/C/827/IA/17
Updated with Decision(2011)4629 of 23/06/2011
28/02/2011 Centralised - Variation EMEA/H/C/827/IB/18/G
Updated with Decision(2011)4629 of 23/06/2011
27/06/2011 Centralised - Variation (2011)4629 of 23/06/2011
26/10/2011 Centralised - Variation EMEA/H/C/827/IA/23
Updated with Decision(2012)769 of 06/02/2012
12/12/2011 Centralised - Notification EMEA/H/C/827/N/24
Updated with Decision(2012)769 of 06/02/2012
08/02/2012 Centralised - Variation (2012)769 of 06/02/2012
25/10/2012 Centralised - Variation EMEA/H/C/827/IB/34
Updated with Decision(2012)8005 of 31/10/2012
06/11/2012 Centralised - Variation (2012)8005 of 31/10/2012
23/07/2013 Centralised - Renewal EMEA/H/C/827/R/36 (2013)4806 of 19/07/2013
04/12/2013 Centralised - Variation EMEA/H/C/827/IB/39
Updated with Decision(2014)9465 of 04/12/2014
08/12/2014 Centralised - Yearly update (2014)9465 of 04/12/2014