Lonquex

RSS

lipegfilgrastim

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

Overview

This is a summary of the European public assessment report (EPAR) for Lonquex. It explains how the European Medicines Agency assessed the medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Lonquex.

For practical information about using Lonquex, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 04/04/2018

Authorisation details

Product details
Name
Lonquex
Agency product number
EMEA/H/C/002556
Active substance
lipegfilgrastim
International non-proprietary name (INN) or common name
lipegfilgrastim
Therapeutic area (MeSH)
Neutropenia
Anatomical therapeutic chemical (ATC) code
L03AA14
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.

Publication details
Marketing-authorisation holder
Sicor Biotech UAB
Revision
12
Date of issue of marketing authorisation valid throughout the European Union
25/07/2013
Contact address
Molėtų pl. 5
LT-08409 Vilnius
Lithuania

Product information

22/02/2018 Lonquex - EMEA/H/C/002556 - P46/09

Contents

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

  • 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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