Tevagrastim

RSS

filgrastim

Authorised
This medicine is authorised for use in the European Union.

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).

This EPAR was last updated on 15/06/2018

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)
  • Neutropenia
  • Hematopoietic Stem Cell Transplantation
  • Cancer
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
10
Date of issue of marketing authorisation valid throughout the European Union
15/09/2008
Contact address
Wasastraße 50
DE-01445 Radebeul
Germany

Product information

31/05/2018 Tevagrastim - EMEA/H/C/000827 - IAIN/0065

Contents

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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.

Assessment history

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