Neulasta

RSS

pegfilgrastim

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

Overview

An overview of Neulasta and why it is authorised in the EU

Neulasta is a medicine used in cancer patients to help with neutropenia (low levels of neutrophils, a type of white blood cell), which is a common side effect of cancer treatment and can leave patients vulnerable to infections.

It is given specifically to reduce the duration of neutropenia and prevent febrile neutropenia (neutropenia accompanied by fever).

Neulasta is not intended for use in patients with the blood cancer chronic myeloid leukaemia or with myelodysplastic syndromes (conditions in large numbers of abnormal blood cells are produced, which can develop into leukaemia).

This EPAR was last updated on 04/10/2018

Authorisation details

Product details
Name
Neulasta
Agency product number
EMEA/H/C/000420
Active substance
pegfilgrastim
International non-proprietary name (INN) or common name
pegfilgrastim
Therapeutic area (MeSH)
  • Neutropenia
  • Cancer
Anatomical therapeutic chemical (ATC) code
L03AA13
Publication details
Marketing-authorisation holder
Amgen Europe B.V.
Revision
32
Date of issue of marketing authorisation valid throughout the European Union
22/08/2002
Contact address
Minervum 7061
NL-4817 ZK Breda
The Netherlands

Product information

13/09/2018 Neulasta - EMEA/H/C/000420 - IAIN/0106

Contents

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Pharmacotherapeutic group

Immunostimulants

Therapeutic indication

Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

Assessment history

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