Nucala
mepolizumab
Table of contents
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.
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List item
Nucala : EPAR - Medicine overview (PDF/70.31 KB)
First published: 03/12/2015
Last updated: 20/09/2019
EMA/466140/2019 -
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List item
Nucala : EPAR - Risk-management-plan summary (PDF/156.22 KB)
First published: 03/12/2015
Last updated: 01/03/2021
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 | |
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Marketing-authorisation holder |
GlaxoSmithKline Trading Services
|
Revision |
14
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Date of issue of marketing authorisation valid throughout the European Union |
01/12/2015
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Contact address |
12 Riverwalk |
Product information
10/02/2021 Nucala - EMEA/H/C/003860 - IA/0041/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
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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.