Cinqaero

RSS

reslizumab

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

Overview

This is a summary of the European public assessment report (EPAR) for Cinqaero. 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 Cinqaero.

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

This EPAR was last updated on 05/12/2018

Authorisation details

Product details
Name
Cinqaero
Agency product number
EMEA/H/C/003912
Active substance
Reslizumab
International non-proprietary name (INN) or common name
reslizumab
Therapeutic area (MeSH)
Asthma
Anatomical therapeutic chemical (ATC) code
R03DX08
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
Teva B.V.
Revision
5
Date of issue of marketing authorisation valid throughout the European Union
15/08/2016
Contact address

Swensweg 5
2031GA Haarlem
The Netherlands

Product information

15/11/2018 Cinqaero - EMEA/H/C/003912 - N/0021

Contents

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

Other systemic drugs for obstructive airway diseases

Therapeutic indication

Cinqaero is indicated as add-on therapy in adult patients with severe eosinophilic asthma inadequately controlled despite high dose inhaled corticosteroids plus another medicinal product for maintenance treatment.

Assessment history

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