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EMA Product

Quofenix

Product approved by European Medicines Agency (EU)

Basic Information

Quofenix

Regulatory Information

EMEA/H/C/004860

Authorised

December 16, 2019

October 17, 2019

9

March 5, 2025

Company Information

Italy

Via Sette Santi 3 Florence

A. MENARINI INDUSTRIE FARMACEUTICHE RIUNITE SRL

Active Substances Detail

Detailed Information

Therapeutic Indication

### 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.

Overview Summary

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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