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 12/06/2018

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 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
Horizon Pharma Europe BV
Revision
7
Date of issue of marketing authorisation valid throughout the European Union
26/03/2015
Contact address
Chiesi Orphan B.V.
Graadt van Roggenweg 340
3531 AH Utrecht
The Netherlands

Product information

07/06/2018 Quinsair - EMEA/H/C/002789 - T/0016

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

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 (CF, see section 5.1).

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

Assessment history

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