Nucala

RSS

mepolizumab

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

Overview

Nucala is used to treat:

  • a particular type of asthma called eosinophilic asthma in patients aged 6 years and above. It is used with other medicines in patients whose asthma is severe and not well controlled with previous treatments;
  • severe chronic rhinosinusitis with nasal polyps (inflamed lining of the nose and sinuses with swellings in the nose) in adults. Nucala is used with a corticosteroid given into the nose when corticosteroid given by mouth or injection with or without surgery does not work well enough;
  • eosinophilic granulomatosis with polyangiitis (EGPA), a disease that causes vasculitis (inflammation of blood vessels) in the lungs, heart, intestines, and nerves. This can lead to asthma, chronic sinusitis and elevated levels of a type of white blood cell called eosinophils. Nucala is used with other medicines in patients aged 6 years and above when EGPA is relapsing-remitting or not well controlled with previous treatments. ‘Relapsing-remitting’ means that the patient has flare-ups of symptoms (relapses) followed by periods of recovery (remissions);
  • hypereosinophilic syndrome (HES), a disease in which eosinophils start growing out of control. It is used with other medicines in adults whose disease is not well controlled with previous treatments and when the disease is linked to a blood abnormality or has no obvious cause.

Nucala contains the active substance mepolizumab.

This EPAR was last updated on 11/10/2022

Authorisation details

Product details
Name
Nucala
Agency product number
EMEA/H/C/003860
Active substance
Mepolizumab
International non-proprietary name (INN) or common name
mepolizumab
Therapeutic area (MeSH)
Asthma
Anatomical therapeutic chemical (ATC) code
R03DX09
Publication details
Marketing-authorisation holder
GlaxoSmithKline Trading Services
Revision
18
Date of issue of marketing authorisation valid throughout the European Union
01/12/2015
Contact address

12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland

Product information

11/10/2022 Nucala - EMEA/H/C/003860 - IB/0051

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

Drugs for obstructive airway diseases

Therapeutic indication

Severe eosinophilic asthma
Nucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older .

Chronic rhinosinusitis with nasal polyps (CRSwNP)
Nucala is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate control.

Eosinophilic granulomatosis with polyangiitis (EGPA)
Nucala is indicated as an add-on treatment for patients aged 6 years and older with relapsing-remitting or refractory eosinophilic granulomatosis with polyangiitis (EGPA).

Hypereosinophilic syndrome (HES)
Nucala is indicated as an add-on treatment for adult patients with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause.

Assessment history

Changes since initial authorisation of medicine

Related content

How useful was this page?

Add your rating
Average
3 ratings
2 ratings
1 rating
1 rating