Cegfila (previously Pegfilgrastim Mundipharma)

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pegfilgrastim

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

Overview

Pegfilgrastim Mundipharma 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). 

Pegfilgrastim Mundipharma 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).

Pegfilgrastim Mundipharma is a ‘biosimilar medicine’. This means that Pegfilgrastim Mundipharma is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Pegfilgrastim Mundipharma is Neulasta. For more information on biosimilar medicines, see 'Related content' below.

Pegfilgrastim Mundipharma contains the active substance pegfilgrastim.

This EPAR was last updated on 12/02/2020

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
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 Biologics S.L.
Date of issue of marketing authorisation valid throughout the European Union
19/12/2019
Contact address

Calle García Ximénez, nº3-1º
31002 Pamplona (Navarra)
Spain

Product information

06/02/2020 Cegfila (previously Pegfilgrastim Mundipharma) - EMEA/H/C/005312 - IAIN/0002

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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