Grasustek

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pegfilgrastim

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

Overview

Grasustek 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 chemotherapy and can leave patients vulnerable to infections.

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

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

Grasustek is a ‘biosimilar medicine’. This means that Grasustek is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Grasustek is Neulasta.

Grasustek contains the active substance pegfilgrastim.

This EPAR was last updated on 28/06/2019

Authorisation details

Product details
Name
Grasustek
Agency product number
EMEA/H/C/004556
Active substance
pegfilgrastim
International non-proprietary name (INN) or common name
pegfilgrastim
Therapeutic area (MeSH)
Neutropenia
Anatomical therapeutic chemical (ATC) code
L03AA13
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

BiosimilarBiosimilar

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
Juta Pharma GmbH
Date of issue of marketing authorisation valid throughout the European Union
26/04/2019
Contact address

Gutenbergstrasse 13
24941 Flensburg
Germany

Product information

20/06/2019 Grasustek - EMEA/H/C/004556 -

Contents

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Pharmacotherapeutic group

Immunostimulants

Therapeutic indication

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

Assessment history

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