Quinsair
levofloxacin
Table of contents
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.
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Quinsair : EPAR - Summary for the public (PDF/77.5 KB)
First published: 12/06/2015
Last updated: 12/06/2015 -
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Quinsair : EPAR - Risk-management-plan summary (PDF/172.17 KB)
First published: 12/06/2015
Last updated: 20/02/2020
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) |
|
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 | |
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Marketing-authorisation holder |
Chiesi Farmaceutici S.p.A
|
Revision |
12
|
Date of issue of marketing authorisation valid throughout the European Union |
25/03/2015
|
Contact address |
Product information
12/11/2020 Quinsair - EMEA/H/C/002789 - IAIN/0026
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.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.