Nyvepria
pegfilgrastim
Table of contents
Overview
Nyvepria 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).
Nyvepria 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).
Nyvepria is a ‘biosimilar medicine’. This means that Nyvepria is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Nyvepria is Neulasta.
Nyvepria contains the active substance pegfilgrastim.
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Nyvepria : EPAR - Medicine overview (PDF/120.63 KB)
First published: 23/11/2020
EMA/559330/2020 -
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Nyvepria : EPAR - Risk-management-plan summary (PDF/653.18 KB)
First published: 23/11/2020
Authorisation details
Product details | |
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Name |
Nyvepria
|
Agency product number |
EMEA/H/C/005085
|
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 |
Pfizer Europe MA EEIG
|
Date of issue of marketing authorisation valid throughout the European Union |
18/11/2020
|
Contact address |
Product information
18/11/2020 Nyvepria - EMEA/H/C/005085 -
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
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).