Cegfila (previously Pegfilgrastim Mundipharma)

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pegfilgrastim

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

Overview

Cegfila 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).

Cegfila 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).

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

Cegfila contains the active substance pegfilgrastim.

This EPAR was last updated on 13/05/2020

Authorisation details

Product details
Name
Cegfila (previously Pegfilgrastim Mundipharma)
Agency product number
EMEA/H/C/005312
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
Mundipharma Corporation (Ireland) Limited
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
19/12/2019
Contact address

Millbank House
Arkle Road
Sandyford Industrial Estate, Dublin 18
Ireland

Product information

17/04/2020 Cegfila (previously Pegfilgrastim Mundipharma) - EMEA/H/C/005312 - N/0003

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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