Tevagrastim
filgrastim
Table of contents
Overview
This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.
If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).
-
List item
Tevagrastim : EPAR - Summary for the public (PDF/42.49 KB)
First published: 29/09/2008
Last updated: 29/09/2008 -
-
List item
Tevagrastim : EPAR - Risk-management-plan summary (PDF/1.16 MB)
First published: 19/10/2020
Authorisation details
Product details | |
---|---|
Name |
Tevagrastim
|
Agency product number |
EMEA/H/C/000827
|
Active substance |
filgrastim
|
International non-proprietary name (INN) or common name |
filgrastim
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
L03AA02
|
Biosimilar |
This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines. |
Publication details | |
---|---|
Marketing-authorisation holder |
Teva GmbH
|
Revision |
13
|
Date of issue of marketing authorisation valid throughout the European Union |
15/09/2008
|
Contact address |
Wasastraße 50
DE-01445 Radebeul Germany |
Product information
01/10/2020 Tevagrastim - EMEA/H/C/000827 - II/0077
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Pharmacotherapeutic group
Immunostimulants
Therapeutic 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.