Fasenra

RSS

benralizumab

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

Overview

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

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

This EPAR was last updated on 16/10/2018

Authorisation details

Product details
Name
Fasenra
Agency product number
EMEA/H/C/004433
Active substance
benralizumab
International non-proprietary name (INN) or common name
benralizumab
Therapeutic area (MeSH)
Asthma
Anatomical therapeutic chemical (ATC) code
R03DX10
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
AstraZeneca AB
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
07/01/2018
Contact address
SE-151-85 Sodertalje
Sweden

Product information

27/02/2018 Fasenra - EMEA/H/C/004433 - IAIN/0001

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

Fasenra is indicated as an add on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long acting β agonists.

Assessment history

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