This medicine is authorised for use in the European Union.


Stimufend is a medicine used in patients with cancer 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).

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

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

Stimufend contains the active substance pegfilgrastim.

This EPAR was last updated on 04/04/2022

Authorisation details

Product details
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Anatomical therapeutic chemical (ATC) code
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.


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
Fresenius Kabi Deutschland GmbH
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Else-Kröner-Straße 1,
61352 Bad Homburg v.d.Höhe

Product information

Stimufend - EMEA/H/C/004780 -

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

  • Immunostimulants

  • Colony stimulating factors

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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