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 18/11/2021

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 monitoringAdditional 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
10
Date of issue of marketing authorisation valid throughout the European Union
15/08/2016
Contact address

Swensweg 5
2031GA Haarlem
The Netherlands

Product information

01/06/2021 Cinqaero - EMEA/H/C/003912 - R/0038

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

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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