Quofenix
delafloxacin
Table of contents
Overview
Quofenix is an antibiotic used in adults to treat:
- bacterial infections of the skin and underlying tissues (acute bacterial skin and skin structure infections);
- community-acquired pneumonia (an infection of the lungs that is caught outside of hospital). It is used when other medicines are not suitable.
It contains the active substance delafloxacin.
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List item
Quofenix : EPAR - Medicine overview (PDF/144.31 KB)
First published: 20/12/2019
Last updated: 04/06/2021
EMA/572803/2019 -
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Quofenix : EPAR - Risk-management-plan summary (PDF/83.19 KB)
First published: 20/12/2019
Last updated: 10/06/2021
Authorisation details
Product details | |
---|---|
Name |
Quofenix
|
Agency product number |
EMEA/H/C/004860
|
Active substance |
delafloxacin meglumine
|
International non-proprietary name (INN) or common name |
delafloxacin
|
Therapeutic area (MeSH) |
Community-Acquired Infections
|
Anatomical therapeutic chemical (ATC) code |
J01MA23
|
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 |
A. Menarini Industrie Farmaceutiche Riunite s.r.l.
|
Revision |
5
|
Date of issue of marketing authorisation valid throughout the European Union |
16/12/2019
|
Contact address |
Via Sette Santi 3 |
Product information
13/10/2022 Quofenix - EMEA/H/C/004860 - IB/0019
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:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
Quofenix is indicated for the treatment of the following infections in adults:
- acute bacterial skin and skin structure infections (ABSSSI),
- community-acquired pneumonia (CAP), when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the initial treatment of these infections (see sections 4.4 and 5.1).
Consideration should be given to official guidance on the appropriate use of antibacterial agents.