QUOFENIX Tablet Ref.[50088] Active ingredients: Delafloxacin

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: A. Menarini – Industrie Farmaceutiche Riunite – s.r.l., Via Sette Santi 3, 50131 Florence, Italy

Product name and form

Quofenix 450 mg tablets.

Pharmaceutical Form

Tablet.

Beige to mottled beige, oblong biconvex tablets of approximately 10 mm width x 21 mm length.

Qualitative and quantitative composition

Each tablet contains delafloxacin meglumine equivalent to 450 mg delafloxacin.

Excipient(s) with known effect: Each tablet contains 39 mg of sodium.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Delafloxacin

Delafloxacin inhibits bacterial topoisomerase IV and DNA gyrase (topoisomerase II), enzymes required for bacterial DNA replication, transcription, repair, and recombination.

List of Excipients

Cellulose, microcrystalline
Povidone
Crospovidone
Sodium hydrogen carbonate
Sodium dihydrogen phosphate monohydrate
Citric acid
Magnesium stearate

Pack sizes and marketing

Laminated aluminium/aluminium foil blisters.

Pack sizes of 10, 20, 30, 50, 60 or 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

A. Menarini – Industrie Farmaceutiche Riunite – s.r.l., Via Sette Santi 3, 50131 Florence, Italy

Marketing authorization dates and numbers

EU/1/19/1393/002-007

Date of first authorisation: 16 December 2019

Drugs

Drug Countries
QUOFENIX Austria, Estonia, Finland, Ireland, Lithuania, Poland, United Kingdom

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