Quinsair

RSS

levofloxacin

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

Overview

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

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

This EPAR was last updated on 22/12/2022

Authorisation details

Product details
Name
Quinsair
Agency product number
EMEA/H/C/002789
Active substance
levofloxacin
International non-proprietary name (INN) or common name
levofloxacin
Therapeutic area (MeSH)
  • Cystic Fibrosis
  • Respiratory Tract Infections
Anatomical therapeutic chemical (ATC) code
J01MA12
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
Chiesi Farmaceutici S.p.A
Revision
15
Date of issue of marketing authorisation valid throughout the European Union
25/03/2015
Contact address

Via Palermo 26/A
43122 Parma
Italy

Product information

23/11/2022 Quinsair - EMEA/H/C/002789 - IB/0034

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

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

Antibacterials for systemic use

Therapeutic indication

Quinsair is indicated for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with cystic fibrosis.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Assessment history

Changes since initial authorisation of medicine

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