Nucala

RSS

mepolizumab

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

Overview

Nucala is an asthma medicine used to treat patients aged 6 years and above with a particular type of asthma called eosinophilic asthma. It is used with other medicines in patients whose asthma is severe and not well controlled with previous treatments.

Nucala contains the active substance mepolizumab.

This EPAR was last updated on 22/10/2018

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
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
GlaxoSmithKline Trading Services
Revision
9
Date of issue of marketing authorisation valid throughout the European Union
01/12/2015
Contact address
Currabinny
Carrigaline
County Cork
Ireland

Product information

26/08/2018 Nucala - EMEA/H/C/003860 - II/0013/G

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

Drugs for obstructive airway diseases

Therapeutic indication

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

Assessment history

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