Ziextenzo
pegfilgrastim
Table of contents
Overview
Ziextenzo 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 (when neutropenia is accompanied by fever).
Ziextenzo 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).
Ziextenzo is a ‘biosimilar medicine’. This means that Ziextenzo is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Ziextenzo is Neulasta.
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List item
Ziextenzo : EPAR - Medicine overview (PDF/76.43 KB)
First published: 16/01/2019
EMA/653854/2018 -
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Ziextenzo : EPAR - Risk-management-plan summary (PDF/140.77 KB)
First published: 16/01/2019
Authorisation details
Product details | |
---|---|
Name |
Ziextenzo
|
Agency product number |
EMEA/H/C/004802
|
Active substance |
pegfilgrastim
|
International non-proprietary name (INN) or common name |
pegfilgrastim
|
Therapeutic area (MeSH) |
Neutropenia
|
Anatomical therapeutic chemical (ATC) code |
L03AA13
|
Additional 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. |
Biosimilar |
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 | |
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Marketing-authorisation holder |
Sandoz GmbH
|
Revision |
5
|
Date of issue of marketing authorisation valid throughout the European Union |
22/11/2018
|
Contact address |
Biochemiestrasse 10 |
Product information
10/06/2022 Ziextenzo - EMEA/H/C/004802 - II/0019
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
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).