Quofenix

RSS

delafloxacin

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

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) when other medicines are not suitable. It contains the active substance delafloxacin.

This EPAR was last updated on 12/05/2020

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)
Skin Diseases, Bacterial
Anatomical therapeutic chemical (ATC) code
J01MA23
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
A. Menarini Industrie Farmaceutiche Riunite s.r.l.
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
16/12/2019
Contact address

Via Sette Santi 3
Florence
Italy

Product information

20/03/2020 Quofenix - EMEA/H/C/004860 - IB/0002/G

Contents

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Pharmacotherapeutic group

Antibacterials for systemic use

Therapeutic indication

Quofenix is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults 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.

Assessment history

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