Pelmeg

RSS

pegfilgrastim

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

Overview

Pelmeg 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).

Pelmeg 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).

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

This EPAR was last updated on 24/02/2023

Authorisation details

Product details
Name
Pelmeg
Agency product number
EMEA/H/C/004700
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
7
Date of issue of marketing authorisation valid throughout the European Union
20/11/2018
Contact address

United Drug House Magna Drive
Magna Business Park
Citywest Road
Dublin 24
Ireland

Product information

24/02/2023 Pelmeg - EMEA/H/C/004700 - IG/1593

Other EU languages available icon 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:

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

To reduce the duration of neutropenia and the incidence of febrile neutropenia due to chemotherapy.

Assessment history

How useful was this page?

Add your rating
Average
1 rating
1 rating
2 ratings