Is Lipegfilgrastim authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Lipegfilgrastim: Lonquex.

Are there safety signals or safety updates for Lipegfilgrastim?

EMA PRAC: 3 entries (latest 2018-05-17).

Active substance

Lipegfilgrastim

EMA 1
Safety 3

Open in the medicines table

EMA European Union — centrally authorised medicines

Lonquex Teva B.V. · Authorised · authorised 25 Jul 2013 · ATC L03AA14

Therapeutic indication (EMA)

Lonquex is indicated in adults and in children 2 years of age and older for reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

Safety signals and safety-related labeling changes

EMA PRAC 17 May 2018 PRAC signal: Pulmonary haemorrhage
Action for MAH: update of the product information: Yes
EMA PRAC 8 Feb 2018 PRAC signal: Aortitis
Action for MAH: update of the product information: Yes
EMA PRAC 1 Sep 2017 PRAC signal: Aortitis
Action for MAH: update of the product information: No

All safety entries for lipegfilgrastim →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.