Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Grastofil   
Auth. number : EU/1/13/877
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: Grastofil 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 Grastofil are similar in adults and children receiving cytotoxic chemotherapy.
Grastofil is indicated for the mobilisation of peripheral blood progenitor cells (PBPCs).
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 Grastofil is indicated to increase neutrophil counts and to reduce the
incidence and duration of infection-related events.
Grastofil 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: Apotex Europe B.V.
Darwinweg 20, NL- 2333 CR Leiden, Nederland

  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
22/10/2013 Centralised - Authorisation EMEA/H/C/2150 (2013)7041 of 18/10/2013
26/11/2013 Centralised - Variation EMEA/H/C/2150/IA/1/G
Updated with Decision(2014)3543 of 22/05/2014
17/12/2013 Centralised - Variation EMEA/H/C/2150/IB/2
Updated with Decision(2014)3543 of 22/05/2014
14/02/2014 Centralised - Variation EMEA/H/C/2150/IB/4
Updated with Decision(2014)3543 of 22/05/2014
27/05/2014 Centralised - Variation EMEA/H/C/2150/II/3/G (2014)3543 of 22/05/2014