Nivestim

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filgrastim

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

Overview

This is a summary of the European public assessment report (EPAR) for Nivestim. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Nivestim.

This EPAR was last updated on 04/12/2018

Authorisation details

Product details
Name
Nivestim
Agency product number
EMEA/H/C/001142
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
Pfizer Europe MA EEIG 
Revision
18
Date of issue of marketing authorisation valid throughout the European Union
07/06/2010
Contact address
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Product information

13/11/2018 Nivestim - EMEA/H/C/001142 - IB/0053

Contents

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Pharmacotherapeutic group

Immunostimulants

Therapeutic indication

Filgrastim 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.

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

Filgrastim is indicated for the treatment of persistent neutropenia (ANC ≤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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