This medicine is authorised for use in the European Union.


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.

This EPAR was last updated on 13/10/2022

Authorisation details

Product details
Agency product number
Active substance
delafloxacin meglumine
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Community-Acquired Infections
Anatomical therapeutic chemical (ATC) code
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.
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Via Sette Santi 3

Product information

13/10/2022 Quofenix - EMEA/H/C/004860 - IB/0019

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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

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.

Assessment history

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